Fiscal Year 2002 Annual Report

Diabetes Mellitus 

Interagency

Coordinating Committee
CONTENTS

Diabetes Mellitus 

Interagency 

Coordinating Committee

Introduction

3 Activities of Member Organizations

3 Agency for Healthcare Research and Quality (AHRQ)

4 Center for Scientific Review (CSR)

5 Centers for Disease Control and Prevention (CDC)

7 Centers for Medicare & Medicaid Services (CMS)

8 Department of Health and Human Services (DHHS)

8 Office of Minority Health (OMH)

11 Office of Public Health and Science (OPHS)

14 Office of the Secretary (OS)

14 Food and Drug Administration (FDA)

15 Health Resources and Services Administration (HRSA)

20 Indian Health Service (IHS)

25 National Center for Complementary and Alternative Medicine (NCCAM)

26 National Center for Health Statistics (NCHS), CDC

27 National Center for Research Resources (NCRR)

29 National Center on Minority Health and Health Disparities (NCMHD)

29 National Eye Institute (NEI)

31 National Heart, Lung and Blood Institute (NHLBI)

33 National Human Genome Research Institute (NHGRI)

35 National Institute of Allergy and Infectious Diseases (NIAID)

38 National Institute of Biomedical Imaging and Bioengineering (NIBIB)

38 National Institute of Child Health and Human Development (NICHD)

40 National Institute of Dental and Craniofacial Research (NIDCR)

41 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

51 National Institute of Environmental Health Sciences (NIEHS)
53 National Institute of General Medical Sciences (NIGMS)

54 National Institute of Mental Health (NIMH)

54 National Institute of Neurological Disorders and Stroke (NINDS)

55 National Institute of Nursing Research (NINR)

56 National Institute on Aging (NIA)

57 National Institute on Alcohol Abuse and Alcoholism (NIAAA)

58 National Institute on Deafness and Other Communication Disorders (NIDCD)

59 National Institute on Drug Abuse (NIDA)

59 National Library of Medicine (NLM)

60 Veterans Health Administration (VHA)

67 National Diabetes Education Program

73 Meeting Summaries

73 The Diabetes Prevention Program (DPP) and Translation – March 11, 2002

99 DMICC: Macrovascular Disease & Diabetes: Translation Issues – July 15, 2002

113 DMICC: The Science of Translation Research: Outcomes and Opportunities – 

September 27, 2002

149 Appendix A: National Diabetes Mellitus Research and Education Act, Section 429

151 Appendix B: DMICC FY 2002 Roster

CONTENTS
INTRODUCTION

In accordance with Section 429 of the National Diabetes Mellitus Research and Education Act, the Diabetes

Mellitus Interagency Coordinating Committee (DMICC) prepares an annual summary report of its activities as

well as other Federal research activities in the field of diabetes. It is submitted to the Secretary, Department 

of Health and Human Services (DHHS), and the Director of the National Institutes of Health (NIH). This is the

annual report of the DMICC for Fiscal Year (FY) 2002.

LEGISLATIVE MANDATE

The DMICC was authorized by Public Law 93-354 and established in fall 1974; subsequent legislation modified

some of the charges to the Committee. The legislative authority of the Committee is presented in Appendix A.

The charge to the DMICC is to coordinate the research activities of the NIH and other Federal agencies relating 

to diabetes mellitus and its complications and to contribute to the adequacy and technical soundness of these

activities by providing a forum for communication and exchange of information.

The Committee includes representatives from Federal agencies whose programs are relevant to diabetes mellitus

and its complications. The chairman, designated by the Director, NIH, is the Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). In FY 2002, the DMICC membership included representatives

of 32 Federal organizations. A roster of Committee members as of the close of the fiscal year is included as

Appendix B.

ACTIVITIES OF THE DMICC

The DMICC facilitates cooperation, communication, and collaboration among agencies that conduct or support

diabetes-related activities. These activities may range from support for biomedical research to direct provision 

of health care services. The DMICC provides both a forum for initiating interactions and a mechanism for 

tracking progress.
ACTIVITIES OF MEMBER ORGANIZATIONS
DMICC ANNUAL REPORT 3 FY 2002

Agency for Healthcare Research and Quality

(AHRQ)

The Agency for Healthcare Research and Quality 

continues to be involved in a broad range of activities

related to improving the quality of health care, reducing its costs, improving patient safety, decreasing

medical errors, and broadening access to essential

services related to diabetes. These activities include

the support of research and collaborations with 

others in the public and private sectors to improve

outcomes for those with diabetes and to prevent 

the condition across the population.

Current Activities

The Agency is funding and involved with a large

number of studies related to diabetes. A new initiative this past year should have major implications 

for efforts to improve the quality of diabetes care.

Under a partnership with the Health Resources 

and Services Administration, AHRQ funded two studies to assess the impacts of the Health Disparities

Collaboratives. Hundreds of Community Health

Centers have been involved in the diabetes collaboratives, a learning process built on the Institute for

Healthcare Improvement’s methods for improving

care and outcomes and the Chronic Illness Model.

The Agency also has numerous ongoing studies 

related to diabetes. Under the TRIP II (Translating

Research Into Practice II) and EXCEED (Excellence

Centers to Eliminate Ethnic/Racial Disparities) 

initiatives, researchers are examining why disparities

exist in the care and outcomes of minorities with

diabetes and what can be done to reduce or eliminate

them. Projects include an examination of the association between diabetes education programs and

quality of care indicators in the Indian Health

Service; implementation of successful managed care

models of diabetes care in underserved populations;

a community-based participatory research study

aimed to improve processes of care for elderly African American diabetics; an evaluation of the impact

of point of service testing of hemoglobin A1c on care

and outcomes; and the development and evaluation

of a culturally sensitive multimedia education program aimed at increasing diabetes-related knowledge,

self-efficacy, and self-care for African Americans 

and Latino populations. Other studies that are being

funded include an assessment of diabetes care in

community health centers, the effects of Navajo interpreters on diabetes outcomes, the effectiveness 

of an automated telephone disease management system for English- and Spanish-speaking patients, and 

an evaluation of the impact of changes in managed

care policy towards reimbursement for glucose selfmonitoring on utilization and outcomes.

Staff at AHRQ are also involved in a number of intramural studies of diabetes. Investigators are using

data from the Medical Expenditure Panel Survey

(MEPS) to develop national estimates for medical visits, individual expenditures, and sources of payment

for people with diabetes. Another study is identifying

factors associated with multiple hospitalizations of

diabetics using Healthcare Cost and Utilization

Project data.

ACTIVITIES OF MEMBER ORGANIZATIONS
AHRQ continues to work with individuals and organizations to ensure that the evidence-base is being

employed. The Agency recently launched an initiative

to strengthen partnerships with stakeholders across

the health care spectrum. Under a partnership with

the American College of Physicians–American Society

of Internal Medicine, the Agency will be involved

with broad efforts to improve the quality of care 

for type 2 diabetes. The Agency also continues its 

involvement with the National Diabetes Quality

Improvement Alliance (formerly called the Diabetes

Quality Improvement Project (DQIP)), an effort to

develop uniform, core measures of diabetes performance that allow benchmarking across organizations

and identify opportunities for improvement among

health plans and providers. Reporting on DQIP measures is now required of managed care organizations

by CMS and results will be madepublicly available.

Future Activities

Much of the work mentioned above will continue

during the next fiscal year. It is expected that 

additional work will be funded under the Agency’s 

program announcements (PAs) and Request for

Applications (RFAs). Priorities with particular pertinence to diabetes include translating research into

practice, patient-centered care, patient safety and

medical errors, and the relationship between 

systems factors and quality.

Center for Scientific Review (CSR)

The Center for Scientific Review is a center within

NIH, where a majority of investigator-initiated applications in diabetes and obesity areas are reviewed.

The mechanisms of application support are the

investigator-initiated individual project applications

(R01s), High Risk/High Impact Pilot grant applications (R21s), Small Business Innovation Research

Applications or Technology Transfer (SBIR/STTR),

and Individual Fellowship Applications: Predoctoral

(F31 and F30), Postdoctoral (F32), and Senior

Fellowships (F33).

Under the above research support application 

mechanisms, pertinent areas that are covered fall

into two main categories: Basic and Clinical

Translational Research. Areas include: Beta Cell

Biology, Islet and Pancreas Transplantation, Insulin

Action, Insulin Resistance, Pathogenesis of Type 1

and Type 2 Diabetes, and also study of pathogenesis

of obesity. These studies invoke molecular genetic,

metabolic (which includes nutritional intervention),

cell biological, and histochemical approaches.

These applications are reviewed in several Integrated

Review Groups (IRGs) within which individual subcommittees (study sections) are located. Each of

these sub-committees has definite expertise to review

specific areas relevant to diabetes and obesity. Thus,

the mission of CSR to activities of DMICC is central

and pivotal through help in maintaining the quality

of diabetes and obesity research in the nation. The

knowledge gained through these NIH-supported 

projects will help control/treat type 1 diabetes and

type 2 diabetes and obesity, in areas of the world

where these diseases are prevalent.

DMICC ANNUAL REPORT 4 FY 2002
Centers for Disease Control and Prevention (CDC)

The mission of CDC is to eliminate the preventable

burden of diabetes through leadership, research,

programs, and policies that translate science into

practice. CDC’s National Diabetes Program conducts

health promotion and disease prevention activities 

to improve the health of people with, or at risk for,

diabetes. CDC’s Diabetes Program is a multifaceted,

science-driven public health program that monitors

the extent of the diabetes program in the United

States through surveillance; translates research 

findings into clinical and public health practice; conducts state-based diabetes prevention and control

programs; and provides information to increase 

public awareness about how to prevent and control

diabetes. The Division of Diabetes Translation at CDC

has these major components: Define the Diabetes

Burden - Public Health Surveillance; Conduct Applied

Translational Research; Develop/Maintain National

and State-based Diabetes Prevention and Control

Programs; and Support for the National Diabetes

Education Program.

Current Activities

National Public Health Initiative on Diabetes and

Women’s Health. Obtained the support of three 

major organizations—American Diabetes Association

(ADA), American Public Health Association (APHA),

Association of State and Territorial Health Officials

(ASTHO); formed a Task Force that proposed recommendations for needed strategies, policies, surveillance, and research to improve the lives of women

across the life stages who are diagnosed with, or 

at risk for, diabetes; prepared an interim report 

that outlines proposed recommendations; and in

August 2002, with a national symposium, selected

recommendations that are of highest priority to

improve the lives of women who are diagnosed or 

at risk for diabetes.

Office of Management and Budget (OMB) Review.

Coordinated a cross-divisional response to an extensive 5-month OMB audit using the Performance

Assessment Rating Tool.

Secretary’s Prevention Initiative. Prepared a diabetes

component of this Initiative that includes proposed

new funding to support pilot projects for primary

prevention of type 2 diabetes.

Primary Prevention of Type 2 Diabetes. Developed

programmatic and scientific strategies to focus on

the population at highest risk for type 2 diabetes—

the sixteen million with “prediabetes”; co-authored

four publications on primary prevention of type 2

diabetes; initiated primary prevention pilot project

with Health Resources and Services Administration

(HRSA) and the Community Health Centers (CHC)

through the National Diabetes Collaborative.

Management Information System. Completed a

Diabetes Management Information System (that

began in 1999) for Diabetes Prevention and Control

Programs to effectively address limited access to

information, non-standardized reporting, limited

accountability, and cumbersome paper trails; as 

of June 28, 2002, all State programs went online;

designed with the ongoing involvement and support

of State program staffs to enable them to share 

information on diabetes and related programs

through a central Internet interface.

Worksite Initiatives. Produced the National Diabetes

Education Program Diabetes Worksite Kit in April

2002 as a Web-based interactive application at diabetesatwork.org, in collaboration with the Washington Business Group on Health.

DMICC ANNUAL REPORT 5 FY 2002
Project DIRECT National Forum. Held in April 

2002 in Raleigh, NC, to share lessons learned from

Project DIRECT (Diabetes Intervention Reaching and

Educating Communities Together) with interested

community and public health program planners;

attended by more than 133 people from 18 States,

one U.S. territory, and the District of Columbia,

who represented diabetes control programs (DCPs),

community health centers, REACH 2010 programs,

community-based organizations, residents of the

Southeast Raleigh community, faith-based organizations, county and State health departments, and

CDC’s Division of Diabetes Translation.

US-Mexico Border Diabetes Prevention and Control

Project. Collaborated with border health offices, the

Mexico Ministry, DCPs in California, New Mexico,

Arizona, and Texas; almost completed (86%) the

prevalence household survey with 3,960 interviews

having occurred in the United States and Mexico;

scheduled to be finished by October 1, 2002; developed a communication plan and project Web site and

established site selection and clinic criteria (Intervention Committee); actively engaged in developing 

a major component of the project—its intervention;

the committee is using a collaboration to gather

input from all partners to develop the intervention.

Community Health Workers and Promotores de

Salud Integrated Projects. The purpose of this project

is to help reduce the burden of diabetes by creating

vital links between health care providers (and/or 

systems) and communities in culturally meaningful

and linguistically appropriate ways by involving the

unique skills of community health workers (CHW)

and promotores de salud in collaboration with health

care teams; conducted a preliminary search for diabetes-related programs and literature and the National Diabetes Prevention Center is compiling these

resources into an accessible format others can use.

National Diabetes Prevention Center (NDPC). NDPC

has formed formal working partnerships directly

with the following American Indian/Alaska Native

organizations—National Indian Council on Aging;

American Indian Higher Education Consortium;

Association of American Indian Physicians; and

Native American Diabetes Program, University of

New Mexico; developed an American Indian/Alaska

Native Interactive Diabetes Atlas using Geographic

Information System mapping technology.

Diabetes Forecasting Models. Developed forecasting

models to provide projections of the numbers of people with diabetes by age, race, sex, and related cost

for the next 50 years and published reports.

Diabetes Translation Research Study: Translation

Research Into Action for Diabetes (TRIAD). Completed collection of baseline data on more than 11,000

patients in largest cohort study designed to monitor

delivery of efficacious preventive care services and

identify modifiable barriers to sub-optimal care;

completed protocol of ancillary study on examining

the relationship of socioeconomic status as a risk

factor for diabetes; completed protocol of ancillary

study on examining the relationship of socioeconomic status as a risk factor for diabetes.

Vision Health. Conducted pilot study of prevalence

and causes of visual impairment and quality of eye

care among people with diabetes in managed care

settings; established a research agenda for eye health

including partnerships with key nonprofit and voluntary organizations; convened expert panel to examine

strategies for eye health.

DMICC ANNUAL REPORT 6 FY 2002
Surveillance in Minority Populations and Other 

Surveillance Issues. Convened expert panel to advise 

us on issues relating to surveillance in minority 

populations; through University of Arizona, completed a BRFSS in-person household survey in an

American Indian population; through NY State

Department of Health, conducted Behavioral Risk

Factors Surveillance System (BRFSS) in New York

Puerto Rican population; final report on Medicaid

surveillance project received and will be edited 

and sent to diabetes control programs; continued 

to provide technical assistance to Indian Health

Service (IHS) on public health surveillance of 

diabetes in American Indians and Alaska Natives.

Future Activities

Plans for Program Effectiveness: Government

Performance and Results Act (GPRA). Achieved 

three of four of the Division’s GPRA measures; 

developed and introduced several new measures 

to gauge intermediate impact and to correspond 

with potential new projects proposed for FY 2004

funding; improvement in documentation of impact

will receive attention.

Implemented Program Effectiveness: Measuring

Program Performance. Finalized the implementation

phase of the division’s MIS; implemented strategies

to strengthen the evaluation skills of the division’s

program development officers and the evaluation

capacity of the DCPs; introduced a new program

assessment approach for the DCPs that is based 

on the 10 Essential Public Health Services.

The Future is Now for Diabetes Prevention and

Control. Plan to expand support for comprehensive

State-based DPCPs and reinforce them as the lead

venue to implement public health programs in 

diabetes; establish epidemiology, health services

research, and programs in primary prevention for

type 2 diabetes that focus on identifying preventive

behavioral strategies for people with pre-diabetes.

Centers for Medicare & Medicaid Services 

(CMS) [formerly HCFA]

Diabetes activities at CMS fell into several broad 

categories: evaluation of the quality of care provided

to Medicare beneficiaries, national and State-level

quality improvement projects designed to improve

care for Medicare beneficiaries; beneficiary educational campaigns; and research to support quality

diabetes care.

Current Activities

The Doctor’s Office Quality Project is a three-State

pilot of an outpatient quality measurement and

improvement model for chronic disease care and 

preventive services that will include diabetes.

The project goal is to develop a model for measurement and improvement of quality care for chronic

disease and prevention services at the level of the

individual physician/medical office. A toolkit of

materials and strategies for improvement will be

developed to support improvement in diabetes care.

The Doctor’s Office Quality Project will also explore

incentives for improving quality of care, including

Continuing Medical Education (CME) provisions,

linkages to reduction in malpractice premiums, and

public recognition. A focus on reduction of disparities

in care has been added to this project. The project

will take place in Iowa, New York, and California.

The National Diabetes Quality Improvement Alliance

is the group that developed the nationally used measure set for diabetes. CMS continues to support and

partner with this effort.

The Quality Improvement Organizations (one per

State) have been working to improve diabetes care 

in the following areas:

• Annual hemoglobin A1c testing.

• Biennial lipid profile.

• Biennial eye examination.

DMICC ANNUAL REPORT 7 FY 2002
These will remain a focus as the Quality Improvement Organizations move into their new contract

cycle, which ends in 2005.

Culturally and Linguistically Appropriate Services 

in Managed Care (CLAS). In June of 2002, the Center

for Beneficiary Services convened a “CLAS”. Best 

Practices Medicare + Choice plans were invited to

share effective strategies for CLAS in their plans.

Based on the presentations, a compendium of best

practices was compiled. The compendium is available

on the web site. The site is http://cms.hhs.gov/

healthplans/quality/project 03.asp. The compendium

is also available through the Quality Improvement

Organizations Net.

Future Activities

Best Practices in Diabetes Conference for Spring

2003. The goal of this conference is to present 

practices that have been successful in improving 

diabetes care over the past 4 years with an emphasis

on practices that have been aimed at improving 

disparities in care. The original conference was a

kick-off in 1999 and was co-sponsored by the

American Diabetes Association and the American

Association of Health Plans. The audience will 

be Medicare + Choice organizations, Quality

Improvement Organizations, Medicaid Agencies,

and any other organization that is interested 

in this topic.

2004 Diabetes National Project. Medicare + Choice

organizations have the option of conducting either

the national diabetes project as defined by CMS or 

a regional collaborative project of their own choosing. The national project will allow the Medicare +

Choice plans the option of focusing on reducing 

disparities in care as opposed to focusing on the

larger diabetic population.

Methods for Increasing Communications With 

People With Medicare. The Center for Beneficiary

Services has an agreement with the National 

Diabetes Educational Program (NDEP) to promote 

preventive services for people with Medicare.

Currently our promotion efforts include the “Power 

to Control Diabetes Is in Your Hands” brochures,

posters, Community Kits, and Practitioner Kits. We

are also preparing a new fact sheet that will advise

people with diabetes about the new self-monitoring

benefit and the medical nutrition benefit to supplement the Power to Control campaign.

Department of Health and Human Services

(DHHS)

DHHS Office of Minority Health

The OMH of the U.S. Department of Health and

Human Services (DHHS) was created in December

1985 with a mission to improve the health of racial

and ethnic minority populations through the development of health policies and programs to address

health disparities and gaps. As called for in its legislative mandate (P.L. 105-392), and consistent with

its mission, OMH’s role is to improve and protect the

health of racial and ethnic minority populations,

eliminate the gap in health status between minority

groups and the rest of the population, and coordinate

across DHHS the development and implementation 

of policies, programs, and practices that will address

health disparities negatively impacting racial and

ethnic minority populations. OMH supports research

and service demonstration programs, conducts evaluation activities, and depends on its resource center

for up-to-date information and information dissemination to inform policy, program, and budgetary

decisionmaking regarding health issues, such as 

diabetes, affecting racial and ethnic populations.

DMICC ANNUAL REPORT 8 FY 2002
Current Activities

During FY 2002, projects in three OMH-funded 

programs and one cooperative agreement targeted

diabetes as a priority health issue.

OMH’s Bilingual/ Bicultural Service Demonstration

Grant Program. The purposes of this program are to: 

• Improve and expand the capacity for linguistic 

and cultural competence of health care professionals and para-professionals working with limited-English-proficient (LEP) minority communities,

specifically Asian Americans, Pacific Islanders, and

Latinos with limited English proficiency.

• Improve the accessibility and utilization of health

care services among the LEP minority populations.

Activities vary by project and include utilizing 

promotores (lay health educators) to conduct education and outreach to the target population; providing diabetes screening in community settings such 

as churches, schools, and work sites; case management to assist individuals with diabetes; conducting 

workshops that encourage physical fitness and 

better nutrition; and developing bilingual health 

education materials.

These projects also reach health care providers to

enhance the quality of care delivered to minorities

with LEP through cultural competency training 

and providing health care facilities with interpreters

for LEP patients. These demonstration programs 

are funded for 3 years. During FY 2002, four projects

were in their first year of operation, and five were 

in their second year. Each project received up to

$150,000 per year of funding.

Health Disparities in Minority Health Grant Program.

This new program was implemented in FY 2001 

with projects funded for 1 or 2 years. This program 

is intended to demonstrate the merit of using local,

small-scale programs to address health problems

and issues that affect the health and well-being 

of local minority populations and to support the 

elimination of racial and ethnic health disparities.

Several of the projects within the Health Disparities

in Minority Health Grant Program addressed diabetes prevention education interventions, selfmanagement educational sessions, and access to

health care for defined minority populations. In 

FY 2001, 12 projects were awarded, and in FY 2002,

five projects were awarded, ranging between $48,000

and $50,000 per year, respectively.

Community Programs To Improve Minority Health

Grant Program. These programs include projects 

targeting diabetes. In general, the purpose of this

program is to improve the health status of targeted

minority populations through health promotion 

and disease risk reduction programs. This program

is different from the previous because it fosters the 

use of a community coalition approach to health 

promotion and risk reduction as a means of reaching

targeted minority populations, especially those at

risk or hard to reach. The program is intended to

demonstrate the effectiveness of coalitions in carrying out projects that coordinate integrated, community-based, educational screening and outreach services, including linkages for access and treatment to

minorities in high-risk, low-income communities,

and that address sociocultural and linguistic barriers to health care.

DMICC ANNUAL REPORT 9 FY 2002
This program supports existing coalitions composed

of three discrete organizations—a minority community-based organization, a health care facility, and 

at least one other entity. Activities of the projects 

targeting diabetes include seeking to improve the

delivery of comprehensive diabetes care in the community through a patient-based care management

model, health care provider education, and telemedicine technology; improving access to health care to

yield an increased number of persons screened for

diabetes among the high-risk population, specifically

Hispanics/Latinos; improving the health and wellbeing of Cherokee women through prevention and

early detection of diabetes; providing immigrants,

refugees, and other low-income residents with the

knowledge, skills, and resources necessary to meet

their health care needs relative to vision and diabetes; and increasing awareness and knowledge 

of diabetes risk factors, prevention strategies, and

methods of treatment and control among the target

population. These demonstration programs are funded for 3 years. During FY 2002, five projects were in

their second year of operation. The projects funded 

in FY 2001 and FY 2002 ranged between $129,595

and $150,000, respectively.

American Indian Higher Education Consortium

Cooperative Agreement. The Centers for Disease

Control and Prevention (CDC), the Indian Health

Service Diabetes Program, and OMH collaborated 

on the project, “Honoring Our Health: Tribal Colleges

and Communities Working Together to Prevent

Diabetes.” In FY 2001, CDC provided $748,000 to 

this project, which is aimed at supporting health 

and reducing the impact of type 2 diabetes in tribal

communities through the involvement of Tribal

Colleges and Universities (TCUs). Subcontracts 

were awarded to 10 TCUs to: 1) develop infrastructure for diabetes education and community mobilization; 2) establish diabetes-related curricula; 

3) connect diabetes prevention to land preservation,

aquaculture, gardens, and bison restoration; 4) 

develop diet-related curricula; 5) increase education,

awareness, and the opportunity to practice good

health behaviors; 6) support community health and

wellness centers; 7) foster faculty development in

diabetes-related fields; and 8) stimulate capacity

building for health-related research.

The 10 TCUs that received funding were:

• Blackfeet Community College, Browning, Montana

• College of Menominee Nation, Keshena, Wisconsin

• Fort Belknap College, Harlem, Montana 

• Fort Peck Community College, Poplar, Montana

• Haskell Indian Nations University, Lawrence,

Kansas 

• Northwest Indian College, Bellingham, Washington

• Sinte Gleska University, Rosebud, South Dakota

• Stone Child College, Billings, Montana 

• Turtle Mountain Community College, Belcourt,

North Dakota

• United Tribes Technical College, Bismarck,

North Dakota

In FY 2002, CDC funds were awarded to fund additional TCU projects, which will be selected through 

a competitive cycle.

DMICC ANNUAL REPORT 10 FY 2002
DMICC ANNUAL REPORT 11 FY 2002

Lastly, the theme of the September/October 2002

issue of the OMH publication, Closing the Gap,

was diabetes and contained information on the link

between diabetes and cardiovascular disease, complications secondary to diabetes, the rise of type 2

diabetes among minority youth, and departmental

campaigns targeting “pre-diabetes” for high-risk 

populations, including Hispanics/Latinos, African

Americans, American Indians/Alaska Natives, and

Asian Americans and Pacific Islanders. Closing the

Gap is a free, monthly publication circulated to more

than 40,000 public and private community-based

organizations, health professionals, State and government representatives, and others. The Office of

Minority Health Resource Center provides free 

information on various health issues, such as diabetes, affecting U.S. minorities, and has up-to-date

information, including Closing the Gap, on its Web

site, www.omhrc.gov.

Future Activities

In FY 2003, OMH will solicit applications for the

three grant programs—Bilingual/Bicultural Service

Demonstration Grant Program, Community Programs

To Improve Minority Health Grant Program, and

Health Disparities in Minority Health Grant Program. Funding will be awarded to the new grantee

partners and those partners who are entering their

second or third year of funding.

DHHS Office of Public Health and Science (OPHS)

The Office of Public Health and Science within 

the Office of the Secretary serves as the focal point

for leadership and coordination in public health 

and science across the U.S. Department of Health 

and Human Services provides direction to program

offices within OPHS and through the Assistant

Secretary for Health provides advice and counsel on

public health and science issues to the Secretary.

OPHS identifies innovative solutions to public health

problems and issues and provides health policy

advice to public health and other professionals and

information to the public to improve the prevention

and treatment of diseases, including diabetes.

Current Activities

Federal Information Resources on Diabetes. The

Office of Public Health and Science established and

coordinates several Federal information resource

centers with toll-free call centers and Internet portals that provide comprehensive and reliable health

information about the causes, treatment, and prevention of diabetes. They include the National Health

Information Center (healthfinder.gov and 800-336-

4797), the National Women’s Health Information

Center, (4woman.gov and 800-994-woman), the Office

of Minority Health Resource Center, (omhrc.gov and

800-444-6472), and nutrition.gov, and fitness.gov. In

2002, nutrition.gov featured an article for the public

on its homepage providing information about the

causes, treatment, and prevention of diabetes.

Within the OPHS, several offices support programs

and initiatives related to diabetes:

The Office of Disease Prevention and Health

Promotion (ODPHP) serves as the overall coordinator

of the national Healthy People 2010 effort. Diabetes

is one of the 28 Healthy People 2010 focus area chapters. The diabetes focus area identifies 17 specific

health promotion and disease prevention objectives

aimed at achieving the goal of using prevention programs to reduce the disease and economic burden 

of this illness and to improve the quality of life for

all persons who have, or are at risk for, diabetes.

In 2002, ODPHP began preparations for a progress

review on diabetes. The purpose of the progress

review, scheduled for December 18, 2002, is to provide a venue for Federal agencies to report on their

progress toward achieving the Healthy People 2010

goals and objectives for diabetes and to integrate

new data to update the status of the specific health

objectives related to diabetes. ODPHP is coordinating

the diabetes progress review, working with the two

lead agencies for this focus area—the Centers for

Disease Control and Prevention and the National 
Institutes of Health. The progress review will provide

an opportunity for discussion about implementation

challenges, strategies, and best practices. It will

identify 1)strategies for overcoming barriers to

achieving the diabetes objectives 2) areas requiring

additional efforts, and 3) the potential for collaborative diabetes prevention and treatment programs 

and initiatives with a broad range of stakeholders

and partners.

The Office on Women’s Health (OWH) programs

include a focus on raising awareness and attention

to diabetes and women. OWH reviews current scientific knowledge to prevent, reduce, or delay onset,

morbidity, and mortality of diabetes and its complications; facilitates (where appropriate) DHHS commitment to the prevention, treatment, control, and

cure of diabetes through discussion of programs,

partnerships, and plans; and serves as a forum to

strengthen partnerships and identify collaborative

opportunities to promote diabetes-related activities.

OWH supports several contracts that promote diabetes awareness and control in women including a

contract awarded to the National Indian Women’s

Health Resource Center for diabetes, lupus, HIV/-

AIDS, and domestic violence for American Indian and

Alaska Native communities. In partnership with the

Food and Drug Administration’s (FDA’s) Office of

Women’s Health, OWH awarded a contract to the

Boston University National Center of Excellence in

Women’s Health to advance research in monitoring

glucose levels in diabetics (to determine the difference in long-term diabetes control with blood glucose monitoring via finger stick versus an alternative

site). Additionally, OWH has participated in a partnership with the Division of Diabetes Translation 

of the CDC’s Office of Disease Prevention and Health

Promotion, to develop an action plan for the “National Public Health Initiative on Diabetes and

Women’s Health.” OWH also partnered with the FDA

Office on Women’s Health in the “Take Time to Care

About Diabetes” initiative. The office works with

many Federal agencies and private sector organizations to provide informational materials on diabetes

for diabetes awareness events and health fairs 

across the country. Publications produced by the

OWH include fact sheets, 2002 Women’s Health

Daybooks, and A Lifetime of Good Health, with 

sections devoted to diabetes.

The President’s Council on Physical Fitness and

Sports (PCPFS) stresses the health benefits of regular

physical activity for all Americans, including people

with chronic health conditions such as diabetes.

Each November, PCPFS publishes a Web site feature

for the American Diabetes Month: “Physical Activity:

A Key to Diabetes Control and Prevention,” which

includes information on physical activity for people

with diabetes and links to other health Web sites as

well. In March 2002, PCPFS published a feature on

the Web on diabetes for the National Diabetes Alert.

Also, in March and November 2002, PCPFS distributed talking points on diabetes for the twenty PCPFS

Council members for use in their public presentations on the health benefits of physical activity.

The Office of the Surgeon General (OSG) released

“The Surgeon General’s Call To Action To Prevent and

Decrease Overweight and Obesity” in December 2001.

This document describes obesity as a risk factor for

diabetes. It also provides a series of recommendations to mobilize all sectors of society to work to

decrease overweight and obesity, to promote healthy

lifestyles, and to decrease the risk of diabetes and

other illnesses. The Surgeon General has also made

numerous speeches and appearances on diabetes and

its prevention. OSG staff work with the leadership of

the American Diabetes Association to develop activities to support diabetes awareness, reduction, and

prevention. Additionally, OSG staff working with 

the leadership of the National Institute of Diabetes

and Digestive and Kidney Diseases identify ways 

in which the Surgeon General can help “spread the

word” about prevention and treatment of diabetes

and its complications.

DMICC ANNUAL REPORT 12 FY 2002
The Office of Population Affairs (OPA) administers

two Federal grant programs, the Title X National

Family Planning Program and the Title XX Adolescent Family Life Program. Both are designed to reduce

the incidence of unintended pregnancies in the populations they serve. The Adolescent Family Life program funds projects that are designed to prevent teen

pregnancy and to provide care and support to pregnant and parenting teens and their families. While

most projects do not directly provide clinical services, they refer for screening and treatment, including

for diabetes, when indicated. The Title X National

Family Planning program funds clinical services

related to family planning and reproductive health.

Specific laboratory testing, including diabetes testing, are required for the provision of specific methods of contraception, either on site or by referral.

Future Activities

National Diabetes Prevention Campaign. On 

November 20, 2002, Secretary Thompson launched 

the first national diabetes prevention campaign in 

an effort to stem the explosion of diabetes in the

United States and to help Americans live longer and

healthier lives. This new campaign, “Small Steps, Big

Rewards” emphasizes that modest lifestyle changes—

including healthier diets and physical activity—can

help prevent the onset of type 2 diabetes, the most

common form of the disease. The program will be 

run by the National Diabetes Education Program,

which is jointly sponsored by DHHS’ National Institutes of Health and the Centers for Disease Control

and Prevention.

Diabetes Progress Review. On December 18, 2002,

the Office of Disease Prevention and Health Promotion will convene the diabetes progress review 

for Healthy People 2010. The diabetes progress

review will identify 1) strategies for overcoming 

barriers to achieving the diabetes objectives,

2) areas requiring additional efforts, and 3) the

potential for collaborative diabetes prevention 

and treatment programs and initiatives with a 

broad range of stakeholders and partners.

Leading Health Indicators. In FY 2003, the U. S.

Department of Health and Human Services plans to

release the first-ever report on the Leading Health

Indicators. The Leading Health Indicators (identified

in Healthy People 2010) are a set of 10 high priority

public health issues in the United States including

physical activity, overweight and obesity, tobacco

use, substance abuse, responsible sexual behavior,

mental health, injury and violence, environmental

quality, immunization, and access to health care.

Progress on these indicators helps to measure the

health status of our country. Several of these health

indicators relate to diabetes prevention and control.

OPHS Consumer Information Resources. New 

information on diabetes will be included on the 

various consumer information Web sites supported

by OPHS including healthfinder.gov, 4woman.gov,

nutrition.gov, and omhrc.gov.

The President’s Council on Physical Fitness and

Sports, a publication on physical activity for people

with chronic health conditions, including diabetes.

Diabetes Town Hall Meeting: A Town Hall meeting 

on Capitol Hill is planned for the spring of 2003

focusing on women’s health and diabetes. The Office

on Women’s Health will co-lead this program with

the FDA’s Office on Women’s Health and the DHHS

Coordinating Committee on Women’s Health to 

highlight DHHS diabetes programs and initiatives.

Congressional, government, community leaders,

and the general public will be invited to participate

in this program.

Women’s Health Screening Day. The Office on

Women’s Health will coordinate a day of free health

screenings for women across the country during May

12–16, 2003. Potential screenings will be for diabetes,

blood pressure, cholesterol, mammography, BMD, and

mental health. The screening day will become a “signature event” for National Women’s Health Week. The

Federal Planning Team includes OPHS, FDA, Health

Resources and Services Administration (HRSA), CDC,

and NIH.

DMICC ANNUAL REPORT 13 FY 2002
Minority Health Grants. In FY 2003, the Office of

Minority Health will solicit applications for the three

grant programs that include a focus on diabetes—

the Bilingual/Bicultural Service Demonstration Grant

Program, Community Programs to Improve Minority

Health Grant Program, and Health Disparities in

Minority Health Grant Program. Funding will be

awarded to the new grantee partners as well as continuation for those partners who are entering their

second or third year of funding.

A Surgeon General’s Report on Prevention is 

under consideration. This report would include 

a focus on diabetes.

DHHS Office of the Secretary (OS)

The Office of the Secretary (OS) provides leadership

and policy direction on programs and initiatives

across the agencies and offices of the U.S. Department of Health and Human Services (DHHS).

Current Activities

Selected diabetes-related initiatives ongoing within

the Office of the Secretary include:

• HealthierUS is a White House initiative with 

leadership from DHHS. The aim of HealthierUS 

is to empower all Americans with the knowledge,

motivation, and skills they need to make healthy

choices in order to prevent diseases such as diabetes; improve government policies and services 

to help provide the American people with an environment that supports healthy choices for disease

prevention; and to increase collaboration among

the Federal Government, States, communities, and

the private sector to ensure that the American people receive health services that are effective and

efficient including those for diabetes prevention

and treatment.

• “VERB: It’s What You Do” a National Youth Media

Campaign. In July 2002, the Secretary of Health

launched this national education campaign that

aims to promote a healthier lifestyle for “tweens”

(children ages 9–13) through physical activity 

and community involvement while decreasing

unhealthy, risky behaviors. The campaign uses

mass media, interactive media, partnerships, and

community events to increase “tweens’” level of

physical activity and positive behaviors in order 

to promote healthy lifestyles and prevent diseases

including diabetes. The Centers for Disease Control

and Prevention are managing this campaign that

encourages youth to pick a verb, such as run, paint,

dance, bowl, and use it as a launching pad to regular physical activity and healthy social behavior.

Food and Drug Administration (FDA)

FDA is charged with approving safe and efficacious

agents for public use. This is especially important

with regard to therapeutic agents in the treatment 

of diabetes mellitus.

There has been a growing recognition that diabetes

is a vascular disease. In the Adult Treatment Panel 

III (ATP III) of the National Cholesterol Education

Program Guideline, diabetes is recognized as a Coronary Heart Disease risk equivalent. Insulin resistance is the hallmark of type 2 diabetes. Since the

approval of the new class of insulin-sensitizing

agents, the thiazolidinediones that decrease hyperinsulinemia by alleviating insulin resistance,

troglitazone, the prototype, was withdrawn from 

the market due to liver toxicity. Two newer members

of the thiazolidinedione class have since beenapproved: rosiglitazone in May and pioglitazone in 

July 1999. Numerous clinical trials are now reporting

multiple cardiovascular benefits of this class of

agents. Recognizing and treating insulin resistance

DMICC ANNUAL REPORT 14 FY 2002
has been the focus of newer therapeutic agents 

approved by FDA this current year. Avandamet (rosiglitazone maleate and metformin HCL) was approved

in October 2002. Megaglip (glipzide/metformin HCL)

was also approved in October 2002. Both were approved either as initial therapy as an adjunct to 

diet and exercise, or as second-line therapy when a

sulfonylurea or metformin do not result in adequate

glycemic control in patients with type 2 diabetes.

Along a similar line to improve glycemic control,

Prandin (repaglinide) was approved for combination

therapy use in patients whose hyperglycemia cannot

be controlled by monotherapy with any of the following

agents: metformin, sulfonylureas, repaglinide, or 

thiazolidinediones.

Other non-thiazolidinedione peroxisome proliferatoractivated receptor (PPAR) dual agonists, active at

both alpha and gamma PPAR receptors, are being

developed by various pharmaceutical companies.

Currently, there are more than a dozen such agents 

in the various phases of the drug development

process. They have been demonstrated to have both

glucose-and lipid-lowering activities.

No significantly new insulin formulation or insulinanalog has been approved this year. The use of parenteral insulin to prevent type 1 diabetes through 

the modulation of anti-islet immune response (“betacell rest”) did not prove to be efficacious in two 

independent controlled trials (the Diabetes Prevention Trial– Type 1 Diabetes Study and the European

Prediabetes Prevention–Subcutaneous Insulin Trial).

Health Care Financing Administration (HCFA) 

See Centers for Medicare & Medicaid Services

(CMS)

Health Resources and Services Administration

(HRSA)

The Health Resources and Services Administration

manages several health care systems programs that

include diabetes identification, education, prevention

or treatment.

Current Activities

Bureau of Primary Health Care. HRSA’s Bureau 

of Primary Health Care (BPHC) established two

strategic goals: to move toward the elimination of

health disparities and toward a 100 percent access

system for all Americans. The Health Disparities

Collaboratives, started in FY1999, seek to: (1) generate and document improved health outcomes for

underserved populations; (2) transform clinical 

practice through new models of care; (3) develop 

infrastructure, expertise, and multi-disciplinary 

leadership to improve health status; and (4) build

strategic partnerships.

The initiative originally focused on diabetes mellitus—to delay or decrease disease complications—

by implementing an evidence-and population-based

model of care, which relies on knowing which patients have the illness and helps them participate 

in their own care. It has six basic elements: support 

of patient self-management, clinical decisions 

support, delivery system redesign, a clinical information system, organization of health care, and

strong partnerships with local government and 

community organizations.

Activities include:

• 367 health centers participated or are in the yearlong diabetes collaboratives. Eighty-eight centers

in 1999, 118 centers in 2000, 62 centers in 2001,

and 67 centers in 2002 are currently participating

in the Diabetes 4 Collaborative.

DMICC ANNUAL REPORT 15 FY 2002
• After completing the year-long collaborative, health

centers continue to receive support to promote the

model of care throughout their organizations, bring

change to clinics, and measure its impact on the

health of underserved patients.

• An orientation and training video and brochure 

describe the initiative.

• A software program was developed to meet the 

need for a comprehensive prevention and multiple 

disease clinical information system.

• Depression screening is included in care of 

diabetes patients.

• Partnerships with other Federal agencies, State 

diabetes control programs, and private-sector 

organizations grow stronger.

Outcomes (through July 2002) include:

• Health centers continue to report on the shared 

key goal that 90 percent of patients with diabetes

will receive two HbA1c tests annually, at least 3

months apart. Starting in 2000, a shared health 

outcome measure was added to all the diabetes 

collaboratives requiring them to report on control

of glucose levels (average HbA1c) and a self-management support measure. Additional measures

focus on prevention of cardiac as well as microvascular complications, the latter including eye,

kidney, and lower extremity disease.

• There are over 60,000 persons with diabetes in 

electronic registries that enable centers to track 

and manage the health of these patients.

• The average HbA1c has decreased from 9.2 to 

8.2 for nearly 24,000 patients in the Diabetes 1 

Collaborative.

• The average HbA1c has decreased from 8.77 to 

8.06 on more than 32,500 patients in the Diabetes 

2 Collaborative.

• The average HbA1c has decreased from 8.63 to 

8.03 on more than 8,500 patients in the Diabetes 

3 Collaborative.

• Average percentage of patients with two HbA1c 

tests in 12 months increased from 24% to 39.2% 

in Diabetes 1, 2, and 3 Collaboratives as they 

disseminated the care model throughout the 

organization and the registry size grew.

• 39.6% of patients have documented collaboratively 

set self-management goals.

Strategic partnerships and infrastructure 

development includes:

• Nine cluster directors and 10 information systems 

specialists are employed by the five lead Primary 

Care Associations.

• Thirty State-based staff provide additional 

support to the centers.

• National BPHC director of the collaboratives 

started in April 2000.

• National BPHC Clinical Information Systems

Coordinator started in December 2001.

• Primary Care-Public Health partnerships are 

highlighted as a programmatic success. The partnership with the Centers for Disease Control and

Prevention’s Division of Diabetes Translation continues to be strengthened.

• 1999: 15 initial partnerships between State health

department Diabetes Control Programs (DCP) and

health centers working on the diabetes collaborative. $1.3 million direct support to health centers

from DCPs.

DMICC ANNUAL REPORT 16 FY 2002
• 2000: $2.7 million support to health centers.

• 2002: additional 15 partnerships formed 

between State health departments Diabetes 

Control Programs.

In 2002 the Agency for Health Research and Quality

began assisting with program evaluation strategy.

Maternal and Child Health Bureau. The Maternal

and Child Health Bureau (MCHB) administers maternal and child health (MCH) Block Grants to States 

to support programs that promote the health of 

all the Nation’s mothers and children and ensure

Statewide systems of health care for the MCH population. Diabetes screening, education, prevention,

and treatment programs may be supported through

these grants.

Additional Title V activities, such as MCH research,

training, genetic services, and MCH improvement

projects, are supported under Special Projects of

Regional and National Significance (SPRANS). While

these activities may not specifically target diabetes

mellitus, core elements of community systems of care

serving children with special health care needs are

addressed by the Program for Children with Special

Health Care Needs. The Healthy Start Initiative to

significantly reduce infant mortality in targeted communities also includes services addressing diabetes in

mothers and children. In addition, MCHB promotes

diabetes detection and care through school-based

and school-linked health programs. Finally, the MCH

Training Program provides training grants to graduate programs and professional schools to support

teaching, research, and service activities that focus

on women and children. Its Leadership Education in

Adolescent Health (LEAH), public health nutrition,

and pediatric nutrition grantee programs include

diabetes education, and the Indiana LEAH is nationally recognized for their work in diabetes.

HIV AIDS Bureau. Derangements of glucose metabolism, including both glucose intolerance and frank

diabetes, have been associated with the use of highly

active antiretroviral therapy to treat HIV infection.

As part of comprehensive primary care, Ryan White

CARE Act funded clinical programs provide monitoring, treatment, patient education, and nutritional

counseling for this complication of HIV treatment.

The AIDS Education and Training Centers provide

education and training to clinicians regarding this

recently described complication and rapidly disseminate information on new treatment strategies as

they evolve.

The Office for the Advancement of Telehealth has,

at a minimum, 16 active grantees that use Telehealth

technologies to provide a range of services to improve the management of diabetic patients. The Office

has funded the Marshfield Medical Foundation to

work with the Office for the Advancement of Telehealth's other grantees to create technical assistance

materials for programs that wish to employ Telehealth technologies in the management of diabetes.

Bureau of Health Professions. The Bureau of 

Health Professions (BHPr), which provides national

leadership in establishing the Nation’s health 

personnel, charges its Division of Health Careers

Development to provide technical assistance to 

community groups to improve the health status 

of diverse and disadvantaged populations significantly affected by diabetes mellitus.

Office of Rural Health Policy. In FY 2002, the Office 

of Rural Health Policy had 19 active Rural Health

Outreach and 2 Rural Network Development grants.

Each grant is awarded for up to 3 years. Currently

there are 7 active grants awarded in 2000, 5 awarded

in 2001, and 10 awarded in 2002. The awards ranged

from approximately $163,000 to $200,000 for FY

2002, each providing a variety of services, which 

may include the delivery of diabetes health care,

treatment, patient education on self-management,

and prevention. Projects focusing primarily on 

diabetes include:

DMICC ANNUAL REPORT 17 FY 2002
• The Diabetes Prevention and Care Project: a 

collaborative effort coordinated and overseen by

the Chiricahua Community Health Center, Elfrida,

Arizona, focuses on the provision of treatment 

and education about diabetes for at-risk individuals in a predominately Hispanic community (68%).

• The Pinal County Public Health Outreach project 

in Coolidge, Arizona, enhances health care services

delivery including diabetes self-management,

education, and prevention.

• The Ajo Community Health Center in Ajo, Arizona,

provides diabetes outreach and education programs to reduce the incidence of diabetes among

Native Americans (46%), Hispanics (26%), and aging

non-Native Americans.

• The Panhandle Area Health Network in Marianna,

Florida, provides diabetes screening, education,

and support to high poverty, chronically ill residents of the panhandle.

• The Baker County Health Department in MacClenny, Florida, connects chronically ill and 

medically underserved adults with appropriate

health care coverage including diabetes.

• The Rural Health Partnership of North Central

Florida in Lake Butler, Florida, provides diabetes

education and outreach to decrease morbidity

among minority and medically underserved 

populations.

• The McKinney Community Health Center in

Waycross, Georgia, provides care, medications,

patient education, and outreach to a population

with a high prevalence of chronic diseases, including diabetes in several southeast counties 

of Georgia.

• The Lowndes County Board of Health in Clyattville,

Georgia, includes The Well City Diabetes initiative

that targets the reduction of type 2 diabetes occurrence and minimizes the long-term complications for

those diagnosed with this disease.

• The East Georgia Health Cooperative, a nine-county

network in Louisville, Georgia, created an outcome

improvement health plan to treat chronic diseases

including diabetes.

• The Moloka’I Heart Health Plan in Kaunakakai,

Hawaii, uses the Cardiovascular Risk Clinic model

to identify native Hawaiians with high rates of 

diabetes, obesity, hypertension, cholesterol, and

smoking and alcohol consumption.

• The We Care Project, Inc. in Great Bend, Kansas,

addresses health disparities among Hispanics 

diagnosed with hypertension and diabetes by 

providing access to care that is affordable and 

culturally and linguistically competent.

• The Salina Cares Health Clinic in Salina, Kansas,

is part of a network of organizations that seek to

improve health care services for the poor and 

uninsured in Central Kansas.

• Migrant Health Services in Moorhead, Minnesota,

provides health care services and uses lay educators to extend education to a migrant farmworker

population, including those diagnosed with diabetes.

• Alcorn State University in Alcorn State, Mississippi, is a Collaborative project that reduces the

incidence of diabetic complications by increasing

access to and coordination of care and by improving self-management practices.

• The Park County Diabetes Project in Livingston,

Montana, seeks to improve knowledge, management, and coordination services for people 

with diabetes.

• The South East Rural Physician Alliance (SERPA) in

Crete, Nebraska, seeks to improve quality care and

treatment by training all SERPA members, increasing public awareness of risk factors, and improving

patient self-management of the disease.

DMICC ANNUAL REPORT 18 FY 2002
• The Fit for Life project in Saranac Lake, New York,

is a supervised exercise program for at-risk residents for heart disease, diabetes, and obesity.

• The Hertford-Gates Health Department (Network)

in Winton, North Carolina, is a multi-level organized network with a community-based approach 

to care for chronic disease management.

• The Hampton Regional Medical Center in Varnville,

South Carolina, seeks to increase patient awareness of the importance of preventive health screenings for diabetes, cancer, and osteoporosis.

• The Rutherford Memorial Hospital in Carthage,

Tennessee, provides access to wellness promotion,

disease prevention, and screening for conditions

such as diabetes, heart disease, cancer, and stroke.

Office of Special Programs. HRSA has been working

with the Organ Procurement and Transplantation

Network, the national system for matching donated

organs with patients on the transplantation waiting

list, to facilitate the allocation of pancreatic organs

for use in pancreatic islet cell transplants in 

treating patients with type 1 diabetes mellitus.

Five transplant centers are now performing islet 

cell transplants.

Future Activities

In FY 2003 the Maternal and Child Health Bureau

will implement the Healthy Communities Innovation

Initiative (HCII), a 20 million dollar effort to improve

prevention strategies for diabetes, obesity, and 

asthma in five communities across the Nation with

demonstrated high rates of these conditions. The 

key features of this initiative include: (1) community

control and implementation of comprehensive, evidence-based programs, (2) significant public/private

coalitions to develop and drive the implementation 

of comprehensive evidence-based programs, and 

|(3) definable health outcome goals and measures 

for accountability.

HCII will be launched in five geographically defined

communities. Based on the principles of innovative

integrated service delivery; community/individual

commitment to goals and objectives; increased

access to preventive, health, education, and social

services; and multi-agency and culturally competent,

family-centered, community-based services, the initiative is centered around the implementation of 

prevention programs that may include: (1) nutrition,

fitness, and smoking cessation counseling services,

(2) community-wide youth fitness programs, (3) expert

disease prevention and management education to children, youth, and families, as well as providers, (4)

increased availability of walking and bike trails that

link schools, work sites, and residential areas, (5)

healthy food options in schools, child care, work

sites, and aging centers, (6) training for families and

providers in identification of conditions and the use

of early interventions, (7) youth speakers bureaus for

community and provider education, and (8) home

modification education and intervention to address

potential allergens.

Although the Healthy Communities Innovation

Initiative targets two conditions in addition to diabetes, the initiative expects to contribute to the

attainment of the goals of the Secretary’s Prevention

Initiative and the Healthy People 2010 Objectives

related to diabetes. These goals include prevention 

of diabetes, reduction in the overall rate of diabetes,

the increase in the proportion of adults who are at a

healthy weight, and the reduction in the proportion

of children and adolescents who are overweight or

obese. In addition, Department of Health and Human

Services has developed shared performance measures

that will guide and focus the work of all participating agencies. This initiative is designed to achieve 

the following specific outcomes related to diabetes

among target populations in communities and States

covered by the program over a five-year period:

DMICC ANNUAL REPORT 19 FY 2002
• Increase by 25% the use of proven clinical preventive services in the areas of diabetes, obesity, and

asthma for both children and adults.

• Increase by 25% the proportion of persons with

impaired glucose tolerance (pre-diabetes) who 

are diagnosed and counseled regarding their risk 

of diabetes.

• Decrease by 25% the number of people with

impaired glucose tolerance (pre-diabetes) who

advance to a diagnosis of diabetes.

• Slow the growth of obesity by 20% for both 

children and adults.

Collaboration among Federal agencies is a required

and key component of this initiative. As indicated 

in the Secretary’s Prevention Initiative, agency programs will be operationalized as integrated efforts

with joint goals, accountability, and timelines. The

announcement of funding will be fully coordinated

among agencies, and funding decisions will be based

on a joint technical review process involving representatives from all agencies. A coordinated evaluation process will be initiated to assess progress on

the joint performance measures on an annual basis.

Indian Health Service (IHS)

The mission of the IHS National Diabetes Program

(NDP) is to develop, document, and sustain a public

health effort to prevent and control diabetes in

American Indian and Alaska Native (AI/AN) people.

The agency promotes collaborative strategies for the

prevention of diabetes and its complications in the

12 IHS Administrative Service Areas (regions) through

coordination of a network of 19 Model Diabetes

Programs and 12 Area Diabetes Consultants. They in

turn provide resource distribution, program monitoring and evaluation activities, and technical support

to 36 Federal hospitals, 63 Federal health centers,

44 Federal health stations, 13 tribal hospitals, 158

tribal health centers, 76 tribal health stations, 34

urban Indian health centers and 170 Alaska village

clinics at the local level in the delivery of comprehensive health care to over 1.5 million American Indians

and Alaska Natives. The NDP also continues to develop and operate the Special Diabetes Program for

Indians grant program with 318 grantees in 35

States. The agency also disseminates current information about all aspects of diabetes surveillance,

treatment, education, and prevention.

Diabetes was the most frequently identified health

problem in IHS Area tribal consultation workshops

for FY 2003 planning. Type 2 diabetes disproportionately affects AI/AN adults who are over 3 times more

likely to have diabetes than the general U.S. population. A recent alarming trend is the increase in prevalence of type 2 diabetes in young AI/AN. Over an 

11 year period, from 1990–2001, the prevalence of

diabetes rose 68% in AI/AN adolescents and young

adults. Recent data show that diabetes mortality is

4.3 times higher in the AI/AN population than in the

U.S. population. There was a 24 percent increase in

the American Indian age-adjusted diabetes-related

death rate from 1991–1993 to 2000. There is clear 

evidence that for Indian people the health disparity

related to diabetes is increasing.

DMICC ANNUAL REPORT 20 FY 2002
Current Activities

Special Diabetes Program for Indians, 1997 Balanced

Budget Act & 2001 Consolidated Appropriations 

Act. In 2002, the IHS National Diabetes Program

administered Year 5 of the Special Diabetes Program

for Indians of the 1997 Balanced Budget Act and the

Consolidated Appropriations Act of 2001. One hundred million dollars per year have been distributed

from these funds through 286 non-competitive grants

administered at 318 sites throughout Indian country.

Over 96% of these funds are distributed through

grants to tribes, IHS facilities, and urban Indian 

centers while 3.8% are withheld for administration 

of the grant program. Tribal entities are the direct

recipients of 81% of the grants, while Federal and

urban programs comprise the remainder. The IHS

National Diabetes Program works closely with the

Tribal Leaders Diabetes Committee to administer 

this program. The Request for Application (RFA)

developed by the IHS NDP this year once again included a Best Practices approach with 14 strategies

identified, researched, and compiled for use by applicants. Sixty-seven percent of the grantees have indicated that they devote a significant portion of their

funding to primary prevention of diabetes. A Final

Report to the Congress summarizing the findings

from this program is being prepared for submission

on January 1, 2003.

IHS became a Deeming Entity for Diabetes Education

Certification. The IHS National Diabetes Program,

with agency and tribal leader support, established 

an Indian Health Diabetes Education Accreditation

Program and received notification from the Centers

for Medicare & Medicaid (formerly HCFA) that the

IHS NDP application to become a deeming entity 

has been approved (Federal Register April 2002). This

process allows Indian health diabetes education programs to become certified and thus seek Medicare

reimbursement for diabetes education. Thus far seven

(programs have applied for and become certified, and

two additional new applications are under review.

Obesity Prevention. For 3 years the IHS National

Diabetes Program has coordinated an obesity prevention initiative targeting Head Start children (0–5 yrs),

families, Head Start staff, and AI communities. Five

tribal Head Start pilot sites, in collaboration with

their respective community health partners, have

developed obesity and diabetes prevention interventions in their local communities. Each Head Start 

site community action plan includes multifaceted

program activities and milestones focusing on

healthy eating, physical activity, healthy behavior

and community partnerships. The core component 

of the initiative is to develop and sustain local community partnerships in the implementation of each

program’s interventions. Each site has fully implemented their respective community plans. The

Initiative is presently addressing dissemination

activities and sharing promising practices with 

other Head Start programs.

Medical Nutrition Therapy (MNT) and Diabetes 

Self-Management Training (DSMT) for Medicare

Beneficiaries. IHS NDP is taking an active role in the

rapid dissemination of information on the two new

Medicare Part B Benefits: Medical Nutrition Therapy

(MNT) and Diabetes Self-Management Training

(DSMT) for Medicare Beneficiaries that have diabetes

and/or kidney disease. We provide technical assistance and consultation to the I/T/U clinicians and

medical records and patient billing office staff on

putting systems into place for electronic billing,

medical records documentation (i.e., MNT PCC+),

tracking of claims and reimbursements and implementing systems to determine outcome- and costeffectiveness of these services. This provides an

other opportunity to promote and facilitate the

implementation of the new third-party collections

opportunities within the I/T/U system.

DMICC ANNUAL REPORT 21 FY 2002
Joslin Vision Network Teleophthalmology Project.

In FY 2002 Congress increased the IHS appropriation 

by $1.5 million to address evaluating American

Indians and Alaska Natives for diabetic retinopathy

through a collaborative project with the Joslin

Diabetes Center using the Joslin Vision Network

(JVN). The JVN is a telemedicine system that uses

low-level illumination and no pupil dilation to

remotely diagnose diabetic retinopathy. The acquired

retinal image is sent electronically to a reading center using existing IHS networks, and an analysis of

the level of diabetic retinopathy is returned to the

remote site. The IHS has deployed imaging sites at

the Phoenix Indian Medical Center (PIMC), Sells PHS

Indian Hospital, Tuba City Indian Medical Center,

Parker Indian Hospital, Hopi Health Care Center, and

the Chief Andrew Isaac Health Center in Fairbanks,

Alaska. Certified readers at the IHS/JVN National

Reading Center in Phoenix evaluate the images

acquired from these sites. Since entering its clinical

phase, the program has evaluated more than 1,500

patients who had not currently met the prescribed

level of care. Many of these required referral due to 

a dangerous level of diabetic retinopathy or other

ocular pathology. Controlled study of this initial outcome indicates that this telemedicine system can

markedly increase the annual diabetic retinopathy

examination rate. The most mature deployment site

increased its examination rate from 47% to more than

70% in less than 1 year. Ten to fifteen additional sites

will be deployed during the next year at locations

throughout Indian country. Primary challenges to

future site development in remote locations include

availability of clinical space and staffing.

Joslin Diabetes Center Partnership. In addition to 

the Joslin Vision Network, the IHS NDP is partnering

with the Joslin Diabetes Center to develop a Webbased system that is based on the case management

model that tracks diabetes care and education called

the Comprehensive Diabetes Management Program

(CDMP). Its components include a Clinical Assessment Module, a Behavioral Assessment Module, and

an Education/Reinforcement Module. Health-care

professionals on this workgroup comprise clinicians

and educators who specialize in diabetes care and

education and represent Joslin, IHS, U.S. Department

of Defense and the U.S. Department of Veterans

Affairs. The CDMP will be integrated with the IHS

electronic medical records system database. Beta

testing of CDMP is targeted for January 2003.

NIDDK/IHS/TLDC/AIHEC collaboration to Recruit

AI/AN Students into Biomedical Science Research

and Diabetes Careers. In FY 2001, at the request 

of tribal leaders serving on the Tribal Leaders Diabetes Committee (TLDC), the IHS and the National

Institute of Diabetes and Digestive and Kidney

Diseases collaborated on a project to encourage

young AI/AN students to consider careers in biomedical research and diabetes. This project also

involves the Centers for Disease Control and Prevention (CDC) and the American Indian Higher Education

Consortium (AIHEC), which represents the 34 tribal

colleges around the country. An RFA was released 

in spring FY 2002 on this interagency collaborative

project designed to increase diabetes knowledge

among AI/AN students through a multicultural diabetes-based science education curriculum for grades

K–8 and high schools. By engaging AI/AN youth in

the biomedical sciences at an early age in a culturally sensitive manner, a goal of increasing the number

of American Indian/Alaska Native health science 

professionals can hopefully be achieved. Eight planning grants, approximately $150,000 each, have 

been awarded to AIHEC institutions throughout

Indian Country.

DMICC ANNUAL REPORT 22 FY 2002
CDC/IHS Collaboration on Redesign of the National

Diabetes Prevention Center. The IHS National Diabetes Program worked closely with the CDC Division

of Diabetes Translation (DDT) in FY 2001 to restructure and re-orient the National Diabetes Prevention

Center (NDPC) in Gallup, New Mexico, to ensure consistency with the NDPC's original mission to provide

diabetes outreach, information, and technical assistance to tribes throughout the U.S. Especially important in this strategic action planning process was a

report containing input from eight regional meetings

with tribal diabetes prevention workers, conducted

in 1999–2000 as a joint effort of CDC and IHS. The

Tribal Leaders Diabetes Committee also provided

valuable advice and guidance during the strategic

planning process—and continues to advise the 

NDPC on a regular basis.

The National Diabetes Prevention Center’s activities

planned for FY 2002 and FY 2003 include gathering,

connecting, and disseminating information about

“what works” in diabetes care and prevention for all

American Indian and Alaska Native communities.

Presently, the NDPC is working in collaboration with

the IHS National Diabetes Program and its partners

to develop a variety of user-friendly tools, resources,

curricula, and data approaches to assist in diabetes

care and prevention efforts; a series of reports about

“what works” in information technology, community

diabetes care, and prevention planning activities;

and educational resources.

IHS NDP continues to collaborate with NDPC on 

the development and printing of the IHS NDP Health

for Native Life magazine. This popular publication 

is developed for members of tribal communities 

who have diabetes and their family members. The

focus is on individuals who have diabetes and the

various educational topics around treatment, care,

and education and community related support systems and activities. A FY 2002 issue highlighted 

the results of the Diabetes Prevention Program and

the American Indian participants. Distribution is 

to I/T/U grant programs, facilities, and tribal 

organizations nationwide.

In addition, the CDC DDT provides diabetes epidemiologic support to the IHS National Diabetes Program

with one full-time position and close collaboration

on projects of mutual concern.

Clinical Standards, Best Practices & the Diabetes

Care and Outcomes Audit. In 2001 the IHS National

Diabetes Program updated the IHS Standards of

Care for Diabetes (originally published in 1986) to

reflect new science and best practices. In 2002 the

IHS National Diabetes Program developed 14 Best

Practices documents, in part based upon these

Standards of Care. The Annual IHS Diabetes Care

and Outcomes Audit, a voluntary medical records

review of 87 clinical care and public health practices

and outcomes, is designed to measure and trend

these standards and best practices. The standards,

best practices documents, and audit summary

results are distributed to providers IHS-wide

through a network of regional Area Diabetes Consultants and local Diabetes Coordinators and are

used as quality indicators at the local, regional,

and national levels to identify specific problems 

and to determine policy and practice.

Collaboration and Partnership with Other Federal

Agencies and Organizations. The IHS NDP Director

serves as a member of the newly formed Translation

Committee of the Diabetes Prevention Program, an

NIH-sponsored study showing that type 2 diabetes

can be prevented. The IHS NDP Director also serves

as a member of the Steering Committee of the National Diabetes Education Committee, a joint effort 

of NIH and CDC to promote national awareness

about diabetes.

DMICC ANNUAL REPORT 23 FY 2002
IHS NDP supports the American Diabetes Association's outreach initiative program for American

Indian/Alaska Native communities: Strong in Body

and Spirit. IHS NDP provides expert guidance related

to diabetes program development and modification

based on participant evaluation.IHS NDP participates in the American Indian subcommittee of the

National Diabetes Education Program. The IHS NDP

provides regular representation to the committee and

helps with the formulation and distribution of program materials. IHS NDP also participates in the

Diabetes in Children and Adolescents Work Group of

the National Diabetes Education Program. The IHS

NDP contributed to the development of the Diabetes

in Schools Guide and will assist in its dissemination

to schools serving AI/AN students.

IHS NDP partners with the National Indian Council

on Aging on a diabetes monograph series, newsletters for tribal leaders, and development of an electronic automated diabetes audit.

A key partnership has been established with the

American Indian Higher Education Consortium

Board to help build tribal college and university

capacity and infrastructure for diabetes training 

and program activities in AI/AN communities.

Several IHS Area Diabetes Programs have partnered

with CDC’s State Diabetes Control Programs (e.g.,

Montana, Alaska, California, New Mexico) to share

skills, resources, and training.

Future Activities

In FY 2003 IHS NDP will develop a Diabetes Collaborative, based on the model used by the Bureau of

Primary Health Care at the Health Resources and

Services Administration, to address primary prevention of type 2 diabetes in AI/AN.

IHS NDP plans to hold a national diabetes conference

in collaboration with the TLDC in Denver, Colorado,

December 2002. The conference will feature successful grant programs and results of the Diabetes Prevention Program study.

IHS NDP will conduct further in-depth evaluation,

validation studies, and key informant interviews of

Special Diabetes Program for Indians grant program

activities, as well as dissemination of successful

grant program strategies.

IHS NDP will implement and fine-tune culturally

acceptable screening approaches for AI/AN 

communities.

IHS NDP will develop and provide more technical

assistance and training (for health professionals,

tribal leadership, administrators, paraprofessionals,

and patients) and promote increased awareness

regarding new diabetes prevention findings 

through media, booklets, Internet, and other 

avenues of communication.

IHS NDP will partner with the American Indian/

Alaska Native Boys and Girls Clubs and the National

Native American Law Enforcement Association

(NNALEA) to promote healthy lifestyles for children

and youth aimed at reducing the risk for early on

set of diabetes in youth.

IHS NDP will continue to promote data improvement

through implementation of an enhanced electronic

medical record specific to diabetes to be used IHSwide, development of an electronic medical records

audit, centralized technical support for the Diabetes

Management System of the IHS electronic medical

record, and ongoing collaboration with and support

for a Diabetes Collaboration amongst the Tribal

Epidemiology Centers.

DMICC ANNUAL REPORT 24 FY 2002
IHS NDP will continue to focus efforts on dissemination of information on the Medicare Part B

Medical Nutrition Therapy (MNT) and Diabetes 

Self-Management Training (DSMT) benefits to 

I/T/U health care facilities. Seeking reimbursement

for MNT and DSMT will have far-reaching benefits

for tribes and tribal communities by increasing

access to diabetes education and nutrition services.

Increased access not only benefits those with diabetes and/or pre-dialysis kidney disease, but also

expands opportunities for lifestyle interventions 

for the primary prevention of diabetes and other 

chronic diseases.

National Center for Complementary and

Alternative Medicine (NCCAM)

The mission of the National Center for Complementary and Alternative Medicine is to support rigorous research on complementary and alternative 

medicine (CAM), to train researchers in CAM, and 

to disseminate information to the public and professionals on which CAM modalities work, which do

not, and why. To achieve its objectives, NCCAM supports basic and clinical research on CAM, awards

grants to train researchers in CAM, and sponsors a

variety of outreach activities. The diabetes-related

projects that NCCAM is currently supporting reflect

its commitment to the clinical study of promising

CAM substances and modalities.

Current Activities

In FY 2001, NCCAM and its cosponsors, the NIH

Office of Dietary Supplements and the National

Institute of Diabetes and Digestive and Kidney

Diseases, released a Program Announcement (PA),

“Chromium as Adjuvant Therapy for Type 2 Diabetes

and Impaired Glucose Tolerance.” The PA’s purpose 

is to generate applications from researchers interested in conducting (1) basic studies of chromium 

action on insulin secretory and signaling pathways

and (2) clinical studies to assess the safety and efficacy of chromium as an adjuvant treatment of type 

2 diabetes and/or impaired glucose tolerance. As a

result of this PA, in FY 2002, the Center funded a

project that is investigating the biochemical basis 

for chromium enhancement of insulin action.

Other diabetes-related projects the Center is 

supporting include basic studies that are examining

the mechanisms by which Ginkgo Biloba may 

accelerate pancreatic function and reduce glucose

metabolism, identifying the anti-hyperglycemic

constituents of Panax ginseng berry, and studying

the synergistic effects between these constituents.

NCCAM is also supporting a project devoted to the

pre-clinical development of a standardized botanical

extract, PMI-5011, which has lowered blood glucose

in insulin-deficient and insulin-resistant animals.

Another NCCAM-sponsored project is studying 

the effectiveness and underlying mechanism of the

angiogenic agent Picroliv for better management of

diabetic wounds, while another project is developing

technology to improve the detection of chromium in

diabetes patients. Finally, the CAM Research Center

for Cardiovascular Diseases is supporting a study

that is examining whether Reiki applied to patients

with painful diabetic neuropathy, with or without

diabetic autonomic neuropathy, can improve the

glycemic control and cardiac autonomic function.

DMICC ANNUAL REPORT 25 FY 2002
NCCAM’s intramural research program has established a Diabetes Unit. Its primary research goals

are: (1) to develop simple methods for assessing

insulin sensitivity and insulin secretion in vivo; (2) 

to evaluate the effects of nutritional supplements 

on insulin sensitivity; and (3) to understand the

molecular mechanisms of insulin action.

In FY 2002, one percent of the NCCAM clearinghouse

inquiries were related to diabetes and CAM therapies. The revamped NCCAM Web site provides links

to informative fact sheets on diabetes and CAM.

Future Activities

The Chromium as Adjuvant Therapy for Type 2

Diabetes and Impaired Glucose Tolerance PA is still

posted on the NCCAM Web site and continues to generate interest from the research community. Further,

NCCAM encourages researchers to submit investigator-initiated applications related to diabetes.

National Center for Health Statistics (NCHS), CDC

NCHS’s mission, as it relates to diabetes, is to monitor and provide national diabetes statistics in the

form of summary health measures and individual

level data for research. This information originates

from vital records, interview and examination surveys, medical records, and patient encounters (such

as, ambulatory care visits).

Current Activities

NCHS released the initial set of data from the 1999-

2000 National Health and Nutrition Examination

Survey (NHANES). This information provides national

estimates of self-reported diabetes, glycemic control,

and hypertension control among people with diabetes. Nutritional assessments and anthropometry

findings were also released. Resources provided by

CDC’s Division of Diabetes Translation facilitated the

analysis of NHANES data on lower extremity disease

risk factors among people with diabetes.

Diabetes information from national vital statistics

were disseminated, including diabetes-related mortality, prevalence estimates of maternal diabetes 

and its risk factors (e.g., maternal weight gain), and

health status of infants born to women with diabetes.

The components of the National Health Care Survey

continue to obtain information on diabetes-related

hospitalizations, doctor office visits, and home health

care. Data from these efforts can characterize trends

in diabetes pharmacologic therapy and patterns of

care for diet and weight counseling and lipid testing.

NCHS continued its collaborative research with 

multiple academic centers, such as the Johns Hopkins University. Published studies include national

assessments of diabetes-attributed mortality, renal

function among persons with diabetes, and progress

toward achieving the national objectives to reduce

the burden of diabetes.

Future Activities

A new U.S. Standard Certificate of Live Birth will be

implemented in 2003, and it will include a question

that differentiates between pre-pregnancy and 

gestational diabetes.

DMICC ANNUAL REPORT 26 FY 2002
With sponsorship by the National Institute of

Diabetes and Digestive and Kidney Diseases, the

National Health Interview Survey will obtain additional information in 2003 on preventive health 

care among people with diabetes.

The 2003 edition of the Health, United States Chartbook on Trends in the Health of Americans, will include a new section on trends in the burden of diabetes.

National Center for Research Resources (NCRR)

NCRR develops and supports research technologies

and shared resources that are critically important 

to research efforts directed at maintaining and

improving the health of our Nation’s citizens. NCRR

programs also provide support for the career 

development of clinical and veterinary biomedical

investigators. The current NCRR diabetes research

portfolio includes approximately 960 basic and 

clinical research subprojects, a significant increase

over the previous year. Selected highlights of NCRRsupported research activities and future plans 

that relate to diabetes are presented below.

Current Activities 

Now in their second year, the 10 NCRR-supported

Islet Cell Resource (ICR) centers provide approved

transplant programs throughout the country with

clinical grade islets to treat patients afflicted with

severe type 1 diabetes. A coordinating center has 

now been established to provide bioinformatics 

and biostatistical support for laboratory studies at

ICRs and clinical programs that use ICR-generated

islets nationwide.

The 81 General Clinical Research Centers (GCRCs)

and their satellites provide the infrastructure needed

by diabetes investigators, who are funded by NIH,

private foundations, and corporations to:

• Study normal and abnormal glucose metabolism,

diabetic complications, islet and whole pancreatic

transplantation, risk factors, epidemiology, genetics, and pharmaceutical interventions.

• Investigate the pathologic consequences of 

diabetes using high-intensity MRI.

• Develop novel treatments using continuous glucose

sensors and insulin pumps.

• Determine the role of race and ethnicity, gender,

age, pregnancy, and patient education in diabetes

prevention and treatment.

Three Science Education Partnership Awards (SEPAs),

which are designed to improve life science literacy,

focus on diabetes and disseminate information about

risk factors and prevention through local science

museums, schools, churches, and community groups.

The NIH Clinical Loan Repayment Program enables

talented physicians to continue their clinical 

research. NCRR sponsors three such individuals

engaged in diabetes research.

The WICELL Research Institute received an NCRR

grant to expand and distribute human embryonic

stem cells, which may lead to new methods by which

islet cells can routinely be generated for subsequent

transplantation into diabetic patients.

NCRR co-sponsored the International Congress of

the Immunology of Diabetes Society and the annual

meeting of the Western Region Islet Study Group.

Researchers continue to develop a computational

metabolic model that can be used to characterize

metabolic function in a single patient with a simple

clinical protocol.

Investigators are characterizing a transgenic mouse

that may be useful as a model for changes that occur

in the heart of diabetics.

DMICC ANNUAL REPORT 27 FY 2002
The Shared Instrumentation Grant program provided

funds for mass spectrometers, flow cytometers,

phosphoimagers, and DNA sequencers to support

diabetes research.

Investigators at six NCRR-supported Research

Centers in Minority Institutions (RCMIs) are studying neuropathy in young Puerto Rican diabetics,

expression of biochemical markers for type I 

diabetes, and health disparities among minority 

populations, particularly along the U.S. and 

Mexican border.

The Clinical Research Education and Career Development Awards at Meharry Medical College and the

University of Puerto Rico support diabetes research

and training.

The Biomedical Research Infrastructure Network 

and the Centers of Biomedical Research Excellence,

part of the Institutional Development Enhancement

Award program, support diabetes research and 

study the effects of childhood obesity, antioxidant

treatment in pregnant diabetic women and their 

offspring, oral health in diabetics, and retinopathy.

NCRR awarded eight research facilities improvement

grants for diabetes-related research.

The NCRR-supported mutant mouse resource for

type 1 diabetes at The Jackson Laboratory now 

has 27 strains of mice ready for distribution and 

an active Web site for information dissemination 

to interested diabetes researchers. The Web site 

also allows the Steering Committee to review submitted type I diabetic mouse strains.

Researchers at the University of Washington National Primate Research Center are investigating 

pancreatic islet cell allograft survival in macaques

and baboons and have found that transplanting

islets without immuno-suppression followed by a

second graft with immuno-suppression facilitates

allo-tolerance of the second graft.

At the University of California-Davis National Primate Research Center, xenografts of islet cells from

pigs to diabetic macaques were successful in 50 

percent of the animals and showed functionality 

for at least 3 months.

Porcine models are being used to investigate the significance of coronary artery disease in type 2 diabetics.

Future Activities 

Planned activities include:

• Define the incidence of b-cell autoimmunity by age,

race/ethnicity, HLA-genotype, and family history 

of type I diabetes and formally evaluate candidate

autoimmunity/diabetes risk factors available for 

all participants( e.g., early childhood diet, reported

infections, and vaccination). Expected outcomes of

the approach are filter paper blood sample testing

to predict and assess relative risks associated with

candidate environmental and genetic factors.

• Expand resources to maintain and supply genetically engineered mouse models for diabetes 

mellitus research including hyperglycemia, hyperinsulinemia, and insulin resistance. Expand and 

improve cryopreservation of murine embryo and

gametes. Improve techniques associated with in

vitro fertilization and intracytoplasmatic sperm

injection methodologies.

• Continue efforts to develop the non-human primate

model for diabetes, using molecular tools to search

for naturally occurring diabetes in non-human primates and to detect genetic predisposition.

NCRR will continue to work with minority-serving

institutions to provide access to Internet2 and

advanced bioinformatics tools to facilitate participation in NIH-sponsored clinical trials, including

those related to diabetes.

DMICC ANNUAL REPORT 28 FY 2002
National Center on Minority Health 

and Health Disparities (NCMHD)

The mission of the National Center on Minority

Health and Health Disparities is to promote minority

health and to lead, coordinate, support, and assess

the NIH effort to reduce and ultimately eliminate

health disparities. In this effort NCMHD will conduct

and support basic, clinical, social, and behavioral

research; promote research infrastructure and training; foster emerging programs, disseminate information; and reach out to minority and other health 

disparity communities.

Building on the work of the former Office of Research

on Minority Health (ORMH) through its partnerships

with the NIH institutes and centers (ICs), the NCMHD

has made remarkable achievements since its establishment just over 1 year ago. NCMHD is particularly

committed to continuing its partnerships with the

National Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK) and other NIH ICs supporting diabetes research and training. While diabetes

affects all groups in the U.S. population, Native

Americans, Mexican Americans, Puerto Ricans, and

African Americans suffer disproportionately compared to the general population. Findings in a recent

National Eye Institute/NCMHD-funded study indicated that increased efforts are needed to improve 

diabetes detection in Mexican Americans.

Current Activities

The Center is addressing disparities in health status

in racial and ethnic minorities with respect to diabetes through the support of research in three broad

areas: preventing or delaying the early onset of 

diabetes through diabetes education and lifestyle

changes, improving the management of and therapies

for diabetes, and the identification of biological and

genomic risk factors for diabetes.

Highlights of FY 2001–2002 diabetes-related specific

accomplishments and activities include the Look

AHEAD program and Project EXPORT Awards.

Look AHEAD (Action for Health in Diabetes) is a 

multicenter randomized clinical trial to examine the

effects of a lifestyle intervention designed to achieve

and maintain weight loss over the long term through

decreased caloric intake and exercise. Look AHEAD

will focus on the disease most affected by overweight

and obesity, type 2 diabetes, and on the outcome that

causes the greatest morbidity and mortality, cardiovascular disease.

Recently, NCMHD awarded grants under the Centers

of Excellence in Partnerships for Community Outreach, Research on Health Disparities and Training

(Project EXPORT). Three grant awards that are diabetes-related are: “Partnerships for Diabetes-Related

Disparities in Hawaii,” “South Hampton Roads EXPORT Center,” and “The Drew/UCLA Project EXPORT

Center.” The Project EXPORT grants aim to build

research capacity at designated institutions enrolling

a significant number of students from health disparity populations and to promote participation and

training in biomedical and behavioral research 

among health disparity populations.

National Eye Institute (NEI)

The National Eye Institute’s mission is to conduct

and support research, training, health information

dissemination, and other programs concerned with

blinding eye diseases, visual disorders, mechanisms

of visual function, preservation of sight, and the special health problems and requirements of the blind.

Diabetes is responsible for diabetic retinopathy, an

eye disease that is the leading cause of blindness in

people between the ages of 24 and 70 years. This disease is characterized by a progressive breakdown of

the normal retinal vascular system.

DMICC ANNUAL REPORT 29 FY 2002
Current Activities

NEI re-issued the program announcement (PA-02-

020), “Strategies To Identify the Genetic Basis of

Diabetic Retinopathy” in order to alert the scientific

community of the continuing interest of NEI in

encouraging research on the genetic basis of this 

disease. This PA seeks grant applications on gene

discovery; genetic epidemiology; methodological

studies of phenotypic assessment of retinopathy,

including possible surrogate markers; and the 

development and application of novel statistical

methods relevant to analyzing genetic data on

diabeticretinopathy. This PA is co-sponsored by the

National Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK). NEI is collaborating with

other NIH institutes and the American Diabetes

Association (ADA) on PA-02-153, “Translational

Research for the Prevention and Control of Diabetes.”

This PA seeks to translate recent advances in the 

prevention and treatment of type 1 and type 2 

diabetes into clinical practice for individuals and 

communities at risk. The NEI continues to participate

with other NIH institutes in a PA entitled “The 

Role of Antioxidants in the Prevention of Diabetic

Complications.” The intent of this PA is to solicit

applications on the role of antioxidants in preventing, delaying, or ameliorating the micro- or macrovascular complications of diabetes as well as the

mechanism(s) by which antioxidants might prevent 

diabetic vascular disease.

NEI is collaborating with other NIH institutes in the

re-issuance of the Request for Application (RFA) entitled, “Bench to Bedside Research on Type 1 Diabetes

and Its Complications,” (RFA-DK-03-001), which seeks

applications involving partnerships between clinical

and basic biomedical researchers with the goal of

translating advances of the molecular basis of type 1

diabetes into new therapies.

NEI continues to participate with NIDDK, the

National Institute of Dental and Craniofacial Research (NIDCR), the National Institute of Neurological

Disorders and Stroke (NINDS), and the National

Heart, Lung and Blood Institute (NHLBI) in a program announcement (PA–99–159) on “The Role of

Growth Factors in the Development of Diabetic

Complications.” This PA encourages grant applications on the role of growth factors in the etiology 

and pathogenesis of the micro- and macrovascular

complications of diabetes.

NEI continues to co-sponsor ACCORD (Action to

Control Cardiovascular Disease Risk in Diabetes),

a large multicenter trial supported by NHLBI and

NIDDK to assess treatments to reduce risk of cardiovascular disease in type 2 diabetes. For this transNIH effort, NEI is sponsoring an eye examination

component in order to collect epidemiological data.

Under the National Eye Health Education Program,

the NEI is expanding its efforts to raise awareness

about eye health among Hispanics. “Ojo con su

Visión”, under the National Eye Health Education

Program (NEHEP), is developing a new national campaign targeting Hispanic adults. Through this effort,

NEI hopes to increase awareness about the importance of dilated eye exams and to tailor vision loss

prevention messages focusing on diabetic eye disease

and glaucoma. NEHEP is developing messages and

materials and identifying dissemination strategies

through news media and community organizations.

Implementation will take place in 2003.

The NEI has begun the development of a diabetic 

eye disease program for American Indians and Alaska

Natives. A working group representing this target

audience has been established to provide guidance 

to the NEI on this new program. The NEI is conducting focus groups and key informant interviews with

the community. This research is being conducted in

collaboration with the tribal networks nationwide.

DMICC ANNUAL REPORT 30 FY 2002
NEI is supporting an initiative on evaluation of 

new treatments for diabetic macular edema, a major

cause of visual loss in patients with diabetes. An 

RFA (EY–01–001) entitled “Diabetic Macular Edema

Clinical Research Network” was issued in June 2001

calling for cooperative agreement applications to 

support core centers to plan, implement, and conduct

clinical trials on the treatment of diabetic macular

edema. The overall goal of this RFA is to develop 

an infrastructure to accelerate the development and

conduct of clinical trials of the treatment of diabetic

macular edema. These include both medical and 

surgical approaches. Grant awards have been made

for a coordinating center in Tampa, Florida, a reading

center in Madison, Wisconsin, and a chairman’s grant

in Boston, Massachusetts. Clinical centers will be

added to the network during the first year of operation. A pilot study is being developed at the NEI 

clinical center and is intended to set the stage for 

a major multicenter randomized clinical trial for 

the treatment of diabetic macular edema.

Another initiative seeks to identify genetic associations in patients with microvascular complications 

of diabetes. NEI continues to supplement the FIND

(Family Investigation of Nephropathy and Diabetes)

study funded by NIDDK to investigate the genetics of

individuals and special populations of patients with

renal disease. NEI is supporting detailed eye examinations for these patients and will search for genetic

associations with microvascular disease.

Future Activities

NEI will continue to incorporate the scientific priorities outlined in the Report of the Congressionally

Established Diabetes Research Working Group in

making funding decisions. NEHEP will continue to

develop and implement outreach activities for people

with diabetes. NEI will continue to encourage experienced investigators from outside vision research to

apply their expertise to develop novel strategies for

increasing knowledge about the pathophysiology 

and treatment of diabetic retinopathy.

National Heart, Lung and Blood Institute

(NHLBI)

The primary cause of death in patients with diabetes

is cardiovascular disease (CVD). NHLBI has continued to expand its comprehensive programs of basic

and clinical research to understand the pathogenesis,

improve treatment, and develop effective prevention

strategies to reduce or postpone the cardiovascular

complications of diabetes. Despite reductions in cardiovascular disease mortality in the general population, patients with diabetes continue to have 2–4

times the CVD rates of non-diabetics of the same 

age, gender, and ethnic group. In addition, recent

studies indicate that current treatments to prevent

these complications may be somewhat less effective

among those with diabetes than in the non-diabetic

population.

Current Activities

During the past year, NHLBI has continued work 

on three major clinical trials that will evaluate 

several therapeutic approaches designed to reduce

cardiovascular complications of diabetes. The Action

to Control Cardiovascular Disease Risk in Diabetes

(ACCORD) trial successfully completed a 1,000

patient Vanguard phase. Recruitment for the main

phase of ACCORD (9,000 additional patients) will

begin shortly. The cohort will be followed over the

next 5 years to evaluate the benefits of intensified

control of hyperglycemia compared to conventional

glucose control and also will test the benefits of

aggressive blood pressure control and intensified

control of the dyslipidemia associated with diabetes

upon CVD rates.

DMICC ANNUAL REPORT 31 FY 2002
The Bypass Angioplasty Revascularization Investigations II Diabetes (BARI 2D) trial is recruiting 

2,800 patients to evaluate whether elective coronary

artery revascularization plus optimal medical management of cardiovascular risk factors and symptoms is superior to optimal medical management

alone. It will also evaluate the important issue of

whether reducing insulin resistance provides protection against cardiovascular complications by testing

whether insulin-sensitizing drugs are superior to

injected insulin or to oral drug regimens that stimulate insulin secretion at levels of glycemic control

that are attainable with current conventional treatments. The National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK) is providing

partial support for the ACCORD and BARI2D trials.

NHLBI is also helping to fund the NIDDK-sponsored

Action for Health in Diabetes (Look AHEAD) trial,

which is evaluating the effect of obesity treatment 

on cardiovascular complications in type 2 diabetic

patients.

Taken together, these three trials should lead to 

new clinical approaches that reduce cardiovascular

complications of both type 1 and type 2 diabetes.

A better understanding of how diabetes causes an

increase in CVD may lead to innovative preventive

treatments. NHLBI supports basic research to identify other ways in which the major vascular complications of diabetes can be retarded or prevented. In

view of the complexity of the available treatments

and the burden they place on patients with diabetes,

it is particularly important to develop new therapies

that can reduce the adverse effects of diabetes on 

the heart and large vessels without requiring intensive efforts at glucose control. NHLBI has expanded

basic research related to macrovascular complications of diabetes including continuation of several

large project grants originally cosponsored with 

the Juvenile Diabetes Foundation.

NHLBI has also participated, in collaboration with

NIDDK, in the program of small, innovative grants

aimed at improved understanding of diabetic macrovascular complications. These have involved studies

of the effects of diabetes on vascular smooth muscle

cells, its effect on circulating growth factors, and 

the effect of salt restriction on insulin sensitivity.

Grants have been awarded to understand the etiology

of diabetes-associated cardiomyopathy, an abnormality that contributes to the high rates of congestive heart failure in diabetic patients.

Other investigations include examining the proatherogenic effect of consumption of a high glycemic

load diet on the endothelium, platelets, and monocytes. Studies will provide much needed information

about the cardiovascular consequences of some of

the commonly used diets in order to properly advise

individuals and the public at-large about the longterm consequences of dieting. In addition, studies

examining the role of enzymes such as the nuclear

enzyme, poly (ADP-ribose) polymerase (PARP), in 

the development of diabetic endothelial dysfunction 

are being conducted. Preliminary data found that

PARP regulates a key pathway that seems to mediate

multiple organ vascular dysfunctions prevalent in

the diabetic population.

NHLBI has also participated, in collaboration with

NIDDK, in the program of small, innovative grants

aimed at utilizing state-of-the-art gene therapy 

approaches for treatment of diabetes and its complications. The information that will be gained with 

the completion of these experiments will be significant in the continued development of angiogenic 

factor gene therapies, offering new technology that

will render the therapies safer for treating cardiovascular ischemic disorders of diabetes.

DMICC ANNUAL REPORT 32 FY 2002
Finally, it is important to recognize that many of the

other research efforts supported by NHLBI may help

to reduce or improve treatment for cardiovascular

diseases occurring in patients with either type 1 or

type 2 diabetes. This is because the effect of diabetes

on macrovascular disease is, at least in part, to accelerate progression of the underlying atherosclerosis

that is also common in non-diabetic individuals in

middle and older ages. Thus, studies on treatment 

of congestive heart failure, treatment of arrhythmias,

including public access to defibrillation, implantation of vascular stents that contain drugs that reduce

restenosis rates, regeneration of cardiac muscle, and

other treatments may have major benefits for

patients with diabetes.

NHLBI support for studies of diabetes-related

macrovascular disease has continued to increase.

Funding for this work expanded further as the 

major clinical trials have moved into their main

recruitment phases. Taken together, these clinical 

and basic studies should provide better guidance 

for physicians to reduce cardiovascular complications of diabetes in the near future and provide 

easier to use, more effective therapies to achieve 

this goal in later years.

National Human Genome Research Institute

(NHGRI)

The National Human Genome Research Institute

leads the National Institutes of Health's (NIH) 

contribution to the International Human Genome

Project, which has as its primary goal the sequencing

of the human genome. As this project nears successful completion, the NHGRI's mission has expanded 

to encompass a broad range of studies aimed at

understanding the structure and function of the

human genome and its role in health and disease.

To that end, NHGRI continues to support two major

diabetes projects conducted by investigators in the

Division of Intramural Research and their collaborators. Both studies aim to identify genetic variations

that lead to increased susceptibility to type 2 diabetes mellitus.

Current Activities

Africa America Diabetes Mellitus (AADM) Study.

There is a paucity of standardized, populationbased data on genetic and epidemiological factors

contributing to the disproportionate increase in 

complex diseases, such as diabetes and cancer, in

African Americans and other minority populations.

The NHGRI aims to collect family and populationbased information in a way that maximizes the 

participation of minority physicians, research scientists, and the community. The identification of genes

underlying susceptibility to common diseases and 

an understanding of the function of these genes 

and their interaction with environmental factors 

will lead to improved management and treatment 

of the diseases.

During the past several years, the National Center for

Minority Health and Health Disparities and NHGRI

have supported innovative research collaboration

between investigators from Howard University and

scientists in the intramural research program of the

NHGRI. The collaboration involves support for projects involving African Americans affected with 

diabetes. To achieve this and other research goals,

the NHGRI assisted Howard University in establishing a Center for collaborative research on genomic

analyses of diseases that disproportionately affect

African Americans. The National Human Genome

Center at Howard University was formally dedicated

on May 1, 2001. Initial efforts to define the scientific

focus and objectives of the Center’s diabetes research

efforts were addressed through peer-reviewed contracts with Howard University as the Coordinating

Center for the Africa America Diabetes Mellitus

(AADM) Study.

DMICC ANNUAL REPORT 33 FY 2002
Because of the high frequency of environmental risk

factors for type 2 diabetes in the African-American

population, it is more productive to study genetic

risk factors in West Africans, since they are thought

by many anthropologists to be the founding population of modern African Americans and have fewer

dietary and nutritional confounding variables. To

establish recruitment sites for the study, five sites

were selected through a peer review process from 

a total of 24 applications, three of them in Nigeria

and two of them in Ghana. Because of logistical 

challenges involved in doing a study of this type 

in West Africa, the study was planned in stages to

allow assessment of the sites’ ability to recruit

appropriate patients and collect blood, urine, and

other clinical data and successfully send the 

samples and data to the Coordinating Center at

Howard University. The 2 year pilot project fully 

met its goal of recruiting 15 affected sibling pairs/

site. Based on this experience, a full-scale study 

was implemented in September 1998 with an 

anticipated total of 400 affected sibling pairs and

200 spouse controls from West Africa by the end 

of the study period.

Genetic analysis of the blood samples was performed

at the Center for Inherited Disease Research (CIDR),

a centralized facility established in 1996 by eight 

Institutes at NIH to provide genetic services for investigators seeking to identify genes that contribute

to human disease. Scientists at the National Human

Genome Center at Howard University and the NHGRI

are currently analyzing the results of the genomewide scan performed at CIDR.

Finnish-U.S. Investigation of NIDDM Genetics.

Type 2 diabetes is one of the major causes of morbidity and mortality in the developed world. While 

environmental factors such as diet play a significant

role, familial clustering indicates that there must 

be significant genetic susceptibility factors at work.

The NHGRI assisted in the development of a consortium of groups who have agreed to pool their 

linkage data on type 2 diabetes in order to study 

the genetic factors involved in this disease. The consortium currently has support from the National

Institute of Diabetes and Digestive and Kidney

Diseases and includes all of the major groups in 

the United States with large family collections as

well as a few European groups.

For 9 years, the Institute's intramural research program has been engaged in a major project, known 

as the Finland-United States Investigation of NonInsulin Dependent Diabetes Mellitus (abbreviated

FUSION), which aims to identify susceptibility genes

for type 2 diabetes and for the related intermediate

quantitative traits in a Finnish population. The data

from the FUSION project represents a major component of the type 2 diabetes consortium's effort. Over

5,000 individuals with diabetes and suitable controls

from Finland are being studied, using careful phenotyping of diabetes and diabetes-associated traits and

genome-wide genetic linkage and association. This

project has made significant progress, shifting

almost entirely from microsatellite analysis to fine

mapping using the mass spectrometer for high

throughput single nucleotide polymorphism (SNP)

genotyping. Further evidence has shown a diabetes

locus on chromosome 22q, narrowing it down to a

few hundred kilobases and confirming the association in a West African sample set. For chromosomes

11q and 20q, where evidence has shown the strongest linkage signals in a genome-wide scan, NHGRI

has generated high density SNP maps and discovered

narrow areas that demonstrate association at the

0.001 to 0.0001 level. The project is now focusing 

on genes in these intervals as possible diabetes 

susceptibility candidates.

DMICC ANNUAL REPORT 34 FY 2002
Cultural and Ethical Issues Associated with Genetic

Family Studies. The Institute’s Ethical, Legal and

Social Implications (ELSI) Program is designed to 

provide a novel approach to scientific research by

identifying, analyzing, and addressing the ethical,

legal, and social implications of human genetics

research at the same time that the basic scientific

issues are being studied. The ELSI Program is funding

a project that aims to examine cultural and ethical

issues associated with participation in genetic family

studies by patients with a family history of type 2

diabetes mellitus in order to enhance the ascertainment process and establish strategies for genetic

counseling of patients and relatives with a family 

history of type 2 diabetes and diabetic neuropathy.

Future Activities

Technology Development for Natural Genetic

Variation. NHGRI started a program to establish 

new academic Centers for advanced genome

research. These Centers of Excellence in Genomic

Science (CEGS) will support multi-investigator,

interdisciplinary teams to develop innovative genomic approaches to address biological problems.

One of the CEGS aims to develop tools for studying

natural genetic variation and to apply those tools to

develop an improved understanding of the molecular

basis of genetic susceptibilities to type 1 diabetes,

progressive supranuclear palsy, and neutropenia.

More broadly, the Center expects, through its development of new technology and close interactions

between theory and experiment, to contribute indirectly to many research projects directed at understanding the genetic contributions to human health

and disease.

National Institute of Allergy and Infectious

Diseases (NIAID)

The National Institute of Allergy and Infectious

Diseases supports a broad range of research on 

the immunopathogenesis of autoimmune diseases,

including type 1 diabetes. Basic research focuses on

understanding the genetics of autoimmunity, elucidating the mechanisms of self-tolerance, developing

approaches to induce self-tolerance, and characterizing pathways of immune-mediated tissue destruction. These studies provide the knowledge to develop

new treatments and diagnostic tests for autoimmune

diseases, including type 1 diabetes, and novel treatments for ongoing disease.

The NIAID chairs the NIH Autoimmune Diseases

Coordinating Committee (ADCC), established in FY

1998 at the request of Congress to increase collaboration and facilitate coordination of research among

NIH Institutes and Centers, other Federal agencies,

and private organizations. In FY 2002, the ADCC completed a comprehensive strategic and collaborative

research plan for autoimmune diseases, which was

mandated in the Children’s Health Act of 2000 (P.L.

106-310). It is anticipated that this research plan 

will be presented to Congress in late 2002. The first

ADCC report, published in December 2000, summarized basic and clinical research programs supported

by NIH and non-Federal organizations, highlighting

coordination and collaborative activities in the 10

thematic areas; described ADCC activities; and 

outlined emerging opportunities for research on

autoimmune diseases.

DMICC ANNUAL REPORT 35 FY 2002
Current Activities 

The NIAID is committed to furthering understanding

of the immunopathogenesis of autoimmune diseases,

including type 1 diabetes, and to promoting the

translation of basic research to clinical applications.

During the past year, the NIAID has continued to

expand its research program in type 1 diabetes. In

FY 1999, NIAID established the Immune Tolerance

Network (ITN), an international consortium dedicated

to the clinical evaluation of novel tolerance induction

approaches for autoimmune diseases, asthma and

allergic diseases, and prevention of graft rejection.

The goal of these therapies is to “re-educate” the

immune system to eliminate injurious immune responses and graft rejection while preserving protective immunity to infectious agents. An important 

aim of the ITN is to explore the immune mechanisms

underlying efficacy (or lack of efficacy) of candidate

approaches. The ITN is conducting clinical trials

involving multiple tolerance induction approaches

for multiple autoimmune diseases, including type 1

diabetes. Examples of the ITN-supported clinical 

trials for type 1 diabetes include: 

• Type 1 diabetes funds have been utilized by the

ITN to develop cell replacement therapy for the

treatment of disease. One of the initial clinical 

trials conducted by the ITN is the “Edmonton 

Protocol,” an experimental islet transplantation 

protocol for brittle type 1 diabetics. To date, the

initial study, conducted by the University of

Alberta, resulted in insulin independence in the

majority of patients. The ITN trial will further

assess the safety and efficacy of this regimen;

expand the capacity for islet preparation and 

clinical transplantation at nine sites in the U.S.,

Canada, and Europe; establish the baseline 

success rate for islet transplantation; and 

facilitate the evaluation of new tolerogenic

approaches for islet transplantation.

• The ITN is developing therapeutic approaches 

for the prevention and reversal of type 1 diabetes.

The ITN plans to initiate enrollment in two clinical

studies to evaluate different approaches in the

treatment of diabetes. One study will evaluate a

humanized monoclonal anti-CD3 antibody recombinantly engineered to lack activating effects on 

target T cells. Another will evaluate the safety of

giving insulin B chain with adjuvant in new onset

diabetics. If this approach proves safe without 

the induction of immunity to the insulin B chain,

further studies to test the ability of this combination to interrupt the autoimmune process in new

onset or at-risk individuals will follow.

• ITN clinical trials will have integrated studies

aimed at identifying the underlying mechanisms

involved in disease progression and therapeutic

actions of the treatment regimens. The ITN has

received two proposals to sequence the regions 

of the NOD (non-obese diabetes) mouse genome

involved in the development of type 1 diabetes.

The proposals were reviewed in FY 2002, award

took place in the third quarter of FY 2002, and 

it is expected that by the end of 2003 that sequencing will be completed.

The ITN includes more than 80 basic and clinical 

scientists and physicians from over 40 institutions 

in the U.S., Canada, Europe, and Australia and is 

co-sponsored by the National Institute of Diabetes

and Digestive and Kidney Diseases (NIDDK) and the

Juvenile Diabetes Research Foundation International

(JDRF). More information on the ITN is available on

their website at http://www.immunetolerance.org.

The NIAID, in collaboration with multiple NIH

Institutes and Offices, has established several large

multidisciplinary research programs for autoimmune

diseases, including type 1 diabetes: 

DMICC ANNUAL REPORT 36 FY 2002
• Autoimmunity Centers of Excellence (ACEs) support collaborative basic and clinical research on

autoimmune diseases and perform clinical trials 

of novel immunotherapies in multiple autoimmune

diseases, including type 1 diabetes. These Centers

conduct basic research into the pathogenesis 

of autoimmunity, immune modulation, and selftolerance. Protocol development for clinical trials

in type 1 diabetes are under development. The

ACEs are co-sponsored by NIDDK, National 

Institute of Arthritis and Musculoskeletal and 

Skin Diseases, and the Office of Research on

Women’s Health.

• NIAID and NIDDK co-sponsored the Request 

for Application “Innovative Partnerships in Type 1

Diabetes Research” to provide access to specialized

expertise or technologies and facilitate the formation of interdisciplinary research partnerships 

to investigate significant biological and medical

problems associated with type 1 diabetes. This 

initiative provides for collaborative research 

partnerships between independent principal 

investigators with expertise in different aspects 

of type 1 diabetes.

• NIAID and NIDDK co-sponsored the RFA “Bench 

to Bedside Research on Type 1 Diabetes and 

Its Complications” to support partnerships between clinical and basic researchers to translate

advances in the understanding of the molecular

basis of type 1 diabetes into new therapies for 

the prevention, treatment, and cure of this disease.

There were a total of 25 applications. NIAID funded three out of the eight supported applications.

• NIAID and NIDDK co-sponsored the RFA “Gene

Transfer Approaches to Enhance Beta-Cell

Transplantation” to support feasibility and pilot

projects for methods to engineer beta cells or 

alter islets to enhance their viability. Successful

projects could lead to an improved supply of islets

for transplantation to treat type 1 diabetes.

• NIAID, with the NIH Office of Rare Diseases, NIH

Office of Research on Women’s Health, the American Autoimmune Related Diseases Association,

and the Sjogrens Syndrome Foundation, co-sponsored a workshop titled “Autoantibodies as Predictors of Autoimmune Diseases.” Using the T1D

autoantibodies as a model, meeting participants

explored the use of autoantibodies as potential

clinical predictors of autoimmune diseases.

Other NIAID-supported research programs include: 

• “Gene Therapy Approaches for Diabetes and Its

Complications” to conduct research on the development of novel vectors and targets in the treatment

of type 1 diabetes;.

• NIDDK “Diabetes Prevention Trial-Type 1,” a multisite cooperative clinical trial for the prevention of

type 1 diabetes in first-degree relatives of patients

with the disease.

• NIDDK’s “Type 1 Diabetes TrialNet,” a consortia 

of clinical centers and core support facilities to

enable rapid and efficient testing of additional

promising new strategies, including vaccines,

to prevent disease or delay its progression.

Future Activities 

NIAID will support new and ongoing clinical trials 

of promising immune therapies for multiple autoimmune diseases through renewal of the Autoimmunity

Centers of Excellence (ACEs) and through the ITN.

The ACEs support collaborative basic and clinical

research on autoimmune diseases, including singlesite and multisite pilot clinical trials of immunomodulatory therapies. These Centers bring together

many different subspecialists (e.g., neurologists,

gastroenterologists, and rheumatologists) and basic

research scientists, increasing clinical and research

collaborations on autoimmunity.

DMICC ANNUAL REPORT 37 FY 2002
National Institute of Biomedical Imaging and

Bioengineering (NIBIB)

The mission of the National Institute of Biomedical

Imaging and Bioengineering (NIBIB or EB) is to

improve health by promoting fundamental discoveries, design and development, and translation

and assessment of technological capabilities in 

biomedical imaging and bioengineering, enabled 

by relevant areas of physics, chemistry, mathematics,

materials science, information science, and the 

computer sciences.

Current Activities

The Institute plans, conducts, fosters, and supports

an integrated and coordinated program of technology

development to improve health.

During the past year, the NIBIB, in collaboration 

with National Institute of Diabetes and Digestive and

Kidney Diseases, National Institute of Dental and

Craniofacial Research, National Institute of Deafness

and Other Communication Disorders, and National

Human Genome Research Institute, released an 

initiative entitled “Sensor Development and Validation.” As a result of this initiative, seven applications specifically related to glucose sensors were

supported. In addition, other grants designed to

address basic technology development applicable 

to the treatment of diabetes were supported.

The Institute coordinates with the biomedical imaging and bioengineering programs of other agencies

and NIH Institutes to support imaging and engineering research with potential medical applications and

facilitates the transfer of such technologies to the

clinical arena.

Within this mission, NIBIB supports hypothesis-,

design-, technology- or problem-driven research

relating to the discovery, design, development, translation, and physical assessment of new knowledge 

in biomedical imaging and bioengineering. The

knowledge gained and the technologies developed 

in this endeavor will be transferred to other Institutes for the refinement and optimization that is

uniquely organ- or disease-specific.

Future Activities

Diabetes research supported by NIBIB will encompass investigation of future methods to image and

cope with this disease. The potential applicability 

of these research results will enable diabetes researchers to improve the well-being of individuals

with diabetes.

Several NIBIB initiatives will be released and 

supported in FY 2003 to address basic technology

development. Of particular interest to the diabetes

community is one that addresses the need to prevent 

biofouling of sensors. The success of this initiative

will prevent the rapid loss of sensor responsiveness

seen with the present glucose sensors.

National Institute of Child Health and 

Human Development (NICHD)

The mission of the National Institute of Child Health

and Human Development is to promote the development of healthy children. Understanding genetic and

environmental factors that contribute to the development of diabetes is consistent with this mission,

given the prevalence of both type 1 and type 2 diabetes in children and the serious complications of

diabetes later in life. The NICHD focuses its efforts 

on the earliest pathogenesis of type 1 diabetes and 

on optimizing insulin therapy in children with type 1

diabetes. In addition, NICHD supports research on

the origins of type 2 diabetes in adolescents and on

improving the outcome of pregnancy in women with

gestational diabetes mellitus.

DMICC ANNUAL REPORT 38 FY 2002
Current Activities

In efforts to prevent type 1 diabetes, the NICHD 

pioneered methods in stratifying levels of risk for

type 1 diabetes mellitus according to genetic and

immunologic markers. This work forms the basis 

of the Diabetes Prevention Trial for Type 1 Diabetes,

a major collaborative, trans-NIH study aimed at 

preventing or delaying the onset of type 1 diabetes.

The NICHD also continues its collaboration with 

the Juvenile Diabetes Research Foundation (JDRF) 

to co-fund two large prospective studies of infants

who have relatives with type 1 diabetes in order to

ascertain the earliest immunologic changes in the

pathogenesis of type 1 diabetes.

The incidence of type 1 diabetes has increased 

steadily over the past 30 years. It is presumed that

environmental factors account for this striking increase in incidence. Epidemiologic studies and animal

models implicate cow milk antigens in infant formula

as an environmental agent that may trigger the autoimmune attack. In order to test this hypothesis, the

NICHD is supporting a randomized controlled clinical

trial. Screening began in FY 2002 to enroll 2,800

infants at high genetic risk of type 1 diabetes, based

on family history and HLA genotype. The infants 

will be randomized to standard infant formula or to

Nutramigen®, a casein hydrolysate. The investigators

will follow the development of autoantibodies in

these children through 2005. Meade- Johnson will

provide the standard formula and the Nutramigen®.

The study will be funded by the NICHD, JDRF, the

Canadian Institutes of Health Research, the European

Foundation for the Study of Diabetes, and the Netherlands Diabetes Foundation. Specially appropriated

type 1 diabetes funds are being used to help support

the first 3 years of the project. These funds are administered by the National Institute of Diabetes and

Digestive and Kidney Diseases (NIDDK).

Although genetic factors predispose children to 

type 1 diabetes, environmental agents are necessary

to trigger the onset of the disorder. In order to 

elucidate this process, the NICHD recently joined

NIDDK to support a Consortium for Identification 

of Environmental Triggers of Type 1 Diabetes. The

consortium will be supported entirely by special

type 1 diabetes funds in FY 2002 and FY 2003. In 

FY 2004-06 the NICHD will support one of the six

centers of the consortium.

NICHD also emphasizes research on the earliest

pathogenesis of insulin resistance and type 2 diabetes. In FY 2002 the Institute continued to support

eight grant applications submitted in response to

Request for Applications in the areas of fetal origins

of adult disease and prevention of type 2 diabetes 

in adolescents. Both of these initiatives focus on 

early pathogenesis of insulin resistance and glucose

intolerance prior to the onset of clinical diabetes.

The investigators of one of these projects reported

recently that oral glucose tolerance testing revealed

states of impaired glucose tolerance in 25% of 

obese children.

NICHD is currently supporting a 15-site, prospective,

international study of hyperglycemia and adverse

pregnancy outcomes. This study of gestational diabetes mellitus will enroll 25,000 women early in their

pregnancy and will follow them through their gestation, delivery, and postpartum period. Their infants

will be studied as well. NIDDK is co-funding this

large study.

Congressional Report 106-293 encourages NICHD 

to work with the National Institute of Allergy and

Infectious Diseases (NIAID) and NIDDK on efforts 

to develop a vaccine to prevent juvenile, or type 1,

diabetes. In response to this Report, NICHD joined

NIDDK in co-funding TrialNet, a Network of 14 

centers designed to perform clinical trials of new

immunomodulatory agents to treat, delay, or prevent

the onset of type 1 diabetes. The NICHD also joined

NIDDK and NIAID in co-funding the Cooperative

DMICC ANNUAL REPORT 39 FY 2002
Study Group for Autoimmune Disease Prevention,

a network of investigators who are developing new

methods to induce immune tolerance to self-antigens

of the beta cells of the pancreas. Ultimately, this collaborative research promises to mitigate or reverse

the autoimmune process that leads to type 1 diabetes.

NICHD also supports a Cooperative Multicenter

Research Network to test the accuracy and efficacy 

of glucose sensors in children with type 1 diabetes.

This effort is designed to reduce the incidence of

hypoglycemic attacks in diabetic children on intensive insulin therapy. This multicenter trial of glucose

sensors in children will utilize funds appropriated by

Congress for research in type 1 diabetes for the first 

3 years and will then be co-funded by NICHD NIDDK.

The Intramural Research Program of NICHD is 

following children in a 15-year study designed to

understand the earliest pathogensis of insulin resistance and glucose intolerance in obese children and 

in non-obese children of obese parents. In two randomized clinical trials, these investigators are also

studying the effects of metformin and orlistat in

obese insulin-resistant children.

Future Activities

The Intramural program plans to initiate a casecontrol study of new-onset type 1 diabetes to 

elucidate the genetic and environmental factors 

that interact to initiate the autoimmune attack on 

the beta cells of the pancreas. The Pediatric Pharmacology Research Unit Network plans to augment 

its Phase 1 and Phase 2 studies of new molecular 

entities designed to ameliorate glucose intolerance 

in children and adolescents.

National Institute of Dental and Craniofacial

Research (NIDCR) 

The mission of NIDCR is to support research on 

the causes, prevention, diagnosis, and treatment of

oral and craniofacial diseases and conditions. The

oral complications of diabetes include greater prevalence and severity of periodontal diseases, increased 

susceptibility to oral mucosal infections, impaired

wound healing, salivary gland dysfunction, and neuropathies resulting in loss or alteration of taste,

smell, and mucosal sensory perception. NIDCR supports research on the oral complications of diabetes

and the effects of oral diseases and conditions on

the metabolic control of blood glucose.

Current Activities

Results of an April 2001 meeting evaluating linkages

between oral health and diabetes were published 

in FY 2002 (Annals of Periodontology Vol 6(1), December, 2001). As reviewed in the publication, a welldocumented relationship exists between diabetes

and increased severity and incidence of periodontitis. Potential underlying mechanisms, including

damage of oral tissues by glycosylated proteins in

the diabetic patient, are discussed. New findings 

are also presented that suggest that periodontitis

adversely affects blood glucose levels in diabetic

patients.

FY 2002 findings from NIDCR-supported basic

research include the following:

• IA-2, a major autoantigen in type 1 diabetes, was

discovered several years ago in NIDCR laboratories. Autoantibodies to IA–2 have been shown to

appear years before the development of clinical

disease and are now being used as a predictive

marker. Recent studies by NIDCR intramural

investigators suggest that IA-2 plays a role in

insulin secretion.

DMICC ANNUAL REPORT 40 FY 2002
• Oral inoculation of normal and diabetic NOD mice

with a periodontal diseases-causing bacterium

resulted in exaggerated bone loss in diabetic mice.

More inflammatory genes were upregulated and a

prolonged inflammatory response occurred in diabetic mice compared to normal mice.

• Monocytes from patients with diabetes appear to

produce more tissue-reactive oxygen products and

to have enhanced enzyme activity associated with

the inflammation.

In addition, studies were initiated on the role of

defects of innate immunity found in diabetic NOD

mice and on abnormal pro-inflammatory cytokine

production in ob/ob diabetic mice and individuals

with type 2 diabetes.

Translational and clinical research/clinical trials

NIDCR supported in FY 2002 include:

• Studies on salivary gland dysfunction in animals

and humans with diabetes.

• A randomized clinical trial to evaluate the effects

of treating periodontal infection in reducing

inflammation and immune cell activation associated with tissue destruction in patients with type 2

diabetes.

• Studies on host/pathogen interactions in endodontic patients with type 1 diabetes.

• Studies on host modulation and the effects of periodontal therapy on diabetic complications.

• A pilot case-control study on the role of periodontal disease in preterm deliveries among pregnant

diabetic Asian and Pacific Islander women.

• A study of racially diverse children and adolescents with type 1 and type 2 diabetes to assess

oral disease burden, determine the natural history

of periodontal complications, and test a health

care provider education program.

An ongoing training and career development program is developing researchers with the skills needed to study relationships between oral and systemic

diseases, including diabetes.

Future Activities

NIDCR continues to participate in two active multiInstitute program announcements (PAs), "The Role 

of Growth Factors in the Development of Diabetes

Complications" and "Enhancing Adherence to Diabetes Self-Management Behaviors." No additional

initiatives are planned.

National Institute of Diabetes and Digestive 

and Kidney Diseases (NIDDK)

The National Institute of Diabetes and Digestive 

and Kidney Diseases (NIDDK) is the lead agency 

of the Federal Government for research efforts to

combat diabetes and its complications. The Division

of Diabetes, Endocrinology and Metabolic Diseases 

has responsibility for extramural programs related

to diabetes research and research training. The

Division of Intramural Research; the Division of

Digestive Diseases and Nutrition; and the Division 

of Kidney, Urologic and Hematologic Diseases support additional diabetes-related activities.

DMICC ANNUAL REPORT 41 FY 2002
Section 330B of the Public Health Service Act 

provides the Secretary, HHS, special funding for

research on the prevention and cure of type 1 diabetes in the amount of $1.14 billion for FY 1998

through FY 2008. The Secretary has designated to

the NIDDK the lead authority for planning, implementing, and evaluating this program. The special

diabetes programs were mandated for the period 

of FY 1998 through FY 2003 by the Balanced Budget

Act of 1997 (P.L. 105-33) and the 2001 Consolidated

Appropriations Act (P.L. 106-554). On December 17,

2002, the President signed the Public Health Service

Act Amendment for Diabetes (P.L. 107-360), which

extends the programs at the level of $150 million 

per year for FY 2004 through FY 2008.

Under the leadership of the NIDDK, the Special

Statutory Funding Program for Type 1 Diabetes

Research has engaged in a broadly consultative

process that includes the participation of multiple

NIH institutes and centers, the CDC, and other 

HHS components in all aspects of the planning,

implementation, and evaluation of the special 

program. In addition, the active involvement of

external scientific and lay experts with respect to

type 1 diabetes and the major diabetes voluntary

organizations--the Juvenile Diabetes Research

Foundation International and the American 

Diabetes Association--has been vital to the program's success in establishing a vigorous and 

productive research enterprise.

The laws that established the special diabetes 

funding programs also mandate interim and final

evaluation reports to the Congress. The interim

report on the special funding program for type 1

diabetes research was transmitted to the Congress

in June 2000. The enactment of P.L. 107-360 changed

the due date of the final program evaluation report

from January 1, 2003, to January 1, 2007.

The NIDDK is in the final stages of preparing the

evaluation report that was originally intended to

meet the January 2003 statutory reporting requirement. Now, with the enactment of P.L. 107-360, the

NIDDK is proceeding to issue the current report

because it provides an important interim assessment

of the program by external scientific experts, grant

recipients, and NIH and CDC staff who have analyzed the associated scientific literature and other

relevant data on the program. Moreover, the report

contains a highly useful summary of research opportunities identified by external experts in the field.

These opportunities can thus serve as a scientific

guidepost in developing this trans-HHS program in

the years ahead.

The NIDDK also led the NIH-wide participation 

in preparation of a detailed progress report,

“Conquering Diabetes: Highlights of Program

Efforts, Research Advances, and Opportunities,”

describing research achievements and initiatives

since 1999, when the Diabetes Research Working

Group (DRWG), published its five-year Strategic 

Plan. The progress report reflects the advice of 

many scientists at the forefront of diabetes research

and identifies new research opportunities that 

have emerged since the DRWG made it recommendations. It also outlines recent advances, both clinical and basic, in type 1 and type 2 diabetes and 

the pre-diabetic conditions, usually asymptomatic,

that precede disease onset.

Current Activities

NIDDK supports a vigorous program of both basic

and clinical research to further understanding of

the development, treatment, prevention, and cure 

of diabetes and its complications. To maximize

research on diabetes, the Institute has fostered collaborations among the many Institutes and Centers

of the National Institutes of Health (NIH), as well 

as with the Centers for Disease Control and Prevention (CDC), the Juvenile Diabetes Research Foundation International (JDRF), and the American

Diabetes Association (ADA).

DMICC ANNUAL REPORT 42 FY 2002
Capitalizing on and responding to recent advances

amd emerging opportunities, the NIDDK continues

to foster cutting-edge research in diabetes—from 

the recognition and support for innovative ideas 

in investigator-initiated research, to the Institute-led

establishment of consortia focused on important

fundamental and clinical research issues. Examples

of ongoing activities and new initiatives for FY 

2002 follow.

Genetics of Type 1 Diabetes: Type 1 diabetes usually strikes in childhood or young adulthood but can

affect an individual at any age. It is an “autoimmune

disease,” in which the body attacks is own tissue.

Type 1 diabetes is characterized by the immune system’s destruction of insulin-producing beta cells,

contained in islets within the pancreas. Without

insulin, the body cannot properly regulate glucose,

lipid, and protein metabolism—resulting in physiologic alterations that can rapidly cause death.

Researchers have yet to determine the precise factors that cause the immune system to initiate this

misguided attack. However, many studies have suggested that an environmental exposure may trigger

this autoimmune disease process in individuals 

who have an underlying genetic susceptibility to

develop type 1 diabetes. Multiple genes are believed

to be involved in this susceptibility and to interact

with each other and with the environment to initiate

the cascade that leads to the development of type 1

diabetes. Several comprehensive new initiatives 

are under way to identify genes conferring risk for

type 1 diabetes.

International Type 1 Genetics Consortium:

Established by the NIDDK, in collaboration with 

the National Institute of Allergy and Infectious

Diseases (NIAID), the National Human Genome

Research Institute (NHGRI), and the JDRF, this 

consortium builds upon recommendations from a

pivotal meeting of international experts held in

November 2000. This consortium is striving to identify type 1 diabetes susceptibility genes by “scanning” human genome sequences in families from 

the U.S., Europe, and Australia. Thus far, the data

from over one thousand diabetic sibling pairs have

been combined and analyzed. These analyses have

revealed several chromosomal regions that may be

harboring diabetes susceptibility genes. Because

large sample sizes are required to identify susceptibility genes, especially for complex diseases such 

as diabetes, the consortium proposes to continue

this effort by collecting data on an additional 2,000

families for genetic analysis.

Genetics of Type 2 Diabetes and Obesity: As with

type 1 diabetes, susceptibility to type 2 diabetes 

and obesity is determined by both genetic and environmental factors. We know that the environmental

factors such as diet and activity are risk factors but

we know much less about the genes involved in disease susceptibility. There are many different pathways that lead to the development of diabetes. The

spectrum of clinical presentations of type 2 diabetes–and the close association of the disease with

other conditions such as obesity, high blood pressure, and lipid abnormalities--add to the complexity

of defining the causative genes. While these considerations make it particularly challenging to identify

the genetic variations that predispose to type 2 diabetes, it is nonetheless critically important to meet

this challenge, given the large and increasing health

burden type 2 diabetes imposes on the American

people and its disproportionately heavy burden on

minority populations.

DMICC ANNUAL REPORT 43 FY 2002
International Type 2 Diabetes Genetic Linkage

Analysis Consortium: The NIDDK has bolstered the

research efforts of this consortium, formed in 1998

to accelerate the search for genes. The pooling of

genetic data from the many groups in the consortium increases the probability of identifying genes

that influence this genetically complex disease. This

combined effort also means that more samples are

available for analysis of individual ethnic groups

than is possible within a single study. With support

from the NIDDK, the groups in the consortium are

currently undertaking more precise mapping of a

region of a potential diabetes susceptibility gene

suspected to be on chromosome 1q as well as investigating potential susceptibility genes on other 

chromosomes. Because African Americans are disproportionately affected by type 2 diabetes and are

underrepresented among the data in the consortium,

the NIDDK has supported the collection of additional DNA samples from this population. These samples

have been genotyped by the NIH-funded Center for

Inherited Disease Research (CIDR) and will be combined with the other African American samples in

the consortium for analysis of genetic variation that

may be specific to this population. Biannual meetings of consortia participants are convened to monitor progress attained to date and to identify new

research avenues and strategies.

Genetics of the Complications of Diabetes: Genes 

are a critical factor not only in the onset of type 1

and type 2 diabetes but also in the onset and progression of the complications that result from 

both forms of the disease. Familial clustering of

complications of diabetes suggests an important

genetic component to their development. Finding

susceptibility genes for complications has important implications for identifying and intervening 

in individuals at increased risk as well as for developing new therapeutic approaches. Several new 

initiatives are under way to identify genes that 

predispose individuals with diabetes to the development of complications. Some of these will use 

samples obtained from populations that have 

been well characterized through participation in

epidemiological studies or clinical trials.

Epidemiology of Diabetes Interventions and Complications (EDIC): An important genetics component

has been added to the EDIC follow-up study of type

1 diabetes patients who participated in the landmark Diabetes Control and Complications Trial

(DCCT). The DCCT demonstrated that patients who

maintain their blood glucose levels as close to normal as possible throughout the day can prevent or

delay eye, kidney, and nerve complications of the

disease. In total, these patients with diabetes have

been followed clinically for up to 15 years. Recently,

the EDIC was expanded to include a genetic study

that will acquire samples from 1,388 patients studied in the DCCT and their parents. Data will be used

initially to study candidate genes that may predispose to diabetic complications.

Family Investigation of Nephropathy and Diabetes

(FIND): Two studies have recently shown that diabetic kidney disease is a highly heritable trait. In

response to this new information, the NIDDK established the FIND study to uncover candidate genes

associated with development of kidney complications in patients with type 1 or type 2 diabetes.

FIND has also incorporated a retinopathy study as

part of its subject evaluation. A specific objective 

is to search for susceptibility genes in subpopulations of Caucasians, African Americans, Hispanic

Americans, and Native Americans across the U.S.

Mouse Models of Diabetic Complications

Consortium: This cross-disciplinary consortium 

will develop mouse models of diabetes complications to facilitate the study of disease prevention

and treatment and the testing of candidate genes

that emerge from human genetic studies. Mice

developed through the consortium will be distributed to the research community. Co-sponsors of 

this initiative are the National Eye Institute; the

National Heart, Lung and Blood Institute; the

National Institute of Dental and Craniofacial

Research, and the JDRF.

DMICC ANNUAL REPORT 44 FY 2002
Beta Cell Biology and Cell Signaling: Further

understanding of cell signaling in the beta cell has

been a top priority because altered function of this

cell is central to the pathogenesis of both type 1 

and type 2 diabetes. Research momentum was

spurred through a series of workshops, entitled

“Pancreatic Development, Proliferation, and Stem

Cells” and “Beta Cell Biology in the 21st Century,”

held in late 2001, to define the current state-of-theart in signaling in the beta cell. These workshops

were an important means of assembling key investigators, recruiting new researchers to the field,

identifying new technologies and approaches to 

be applied, and defining goals for future work.

Initiatives have been designed to promote the development of multi-disciplinary consortia among 

laboratories to bring resources to bear more effectively on cell signaling and cell regulation in the

beta cell. The Beta Cell Biology Consortium will

work to apply the tools of functional genomics 

to the endocrine pancreas, to identify the genes

expressed in mouse and human pancreas at all

stages of development, and to generate DNA arrays

and other tools to facilitate the identification of

important signaling components. This consortium

will also attempt to delineate pathways of islet and

beta cell signaling in development, and potentially,

in beta cell renewal. A second initiative, Comprehensive Programs in Beta Cell Biology, will bolster

investigator-initiated collaborative research focused

on signaling networks within the adult beta cell 

and the integration of signaling networks within 

the pancreatic islet. It will seek to characterize each

step in the molecular pathway by which glucose

stimulates insulin secretion, mechanisms by which

other signals modify beta cell function, and the 

factors that regulate beta cell growth.

Genome Anatomy Projects: To build upon the

achievements of the Human Genome Project, the

NIDDK has established a range of Genome Anatomy

Projects (GAPs) to map the complex network of cellular interactions in normal and diseased tissues.

The beta cell consortia described previously comprise one such GAP. Other related large-scale projects will foster multi-disciplinary team approaches

applying genomic and proteomic technology to

understanding, at the molecular level, the signaling

events in tissues involved in the pathogenesis of

diabetes and its complications. Efforts will focus on

developing a comprehensive understanding of tissues that are major sites of insulin action—such as

liver, muscle and fat—and how signaling and cell

regulation are altered in diabetes.

The Diabetes Genome Anatomy Project (DGAP) will

enable researchers to take a systematic approach 

to the complex problem of diabetes by cataloging 

all genes expressed in tissues relevant to the disease. The initial step in this multi-faceted program

was an initiative on the Functional Genomics of 

the Developing Pancreas. This program has already

identified 500 novel genes expressed primarily in 

the pancreas. These genes are being evaluated using

microarray technology to understand their function

in the pancreas and how their expression is altered

in diabetes. Based on the success of this approach,

the NIDDK now plans to expand this effort to other

tissues affected by diabetes. To make these technologies widely available to researchers, the NIDDK also

established Biotechnology Centers to provide gene

profiling resources to investigators working on diabetes and other diseases.

DMICC ANNUAL REPORT 45 FY 2002
DMICC ANNUAL REPORT 46 FY 2002

Clinical Trials and Clinical Research: The NIDDK

has significantly expanded clinical trials and clinical research directed at advancing the prevention

and care of diabetes. In particular, considerable

work has been done to establish the clinical 

infrastructure needed to efficiently conduct large,

long-term trials by creating national, multi-center

research networks or consortia. Many of these

consortia provide opportunities for partnerships

between the NIH, academia, and industry for collaboration and co-funding of clinical trials and for 

support of clinical research training in diabetes.

They also provide for collection of biologic specimens for use in ancillary clinical research studies 

to address key questions of disease pathogenesis

and mechanisms of response to therapies as well 

as opportunities for development and validation of

surrogate markers that can be used to gauge the

health of the patient before development of diabetes

or its complications. This section of the report describes major new results achieved and new clinical

research undertaken to address the prevention and

treatment of diabetes and its many complications.

Prevention of Type 2 Diabetes in People at High Risk:

The Diabetes Prevention Program (DPP) demonstrated that individuals at substantial risk of developing

type 2 diabetes could prevent or delay disease onset

and improve their blood sugar levels through modest improvements in diet and exercise. Minority

groups who suffer disproportionately from type 2

diabetes—African Americans, Hispanic Americans,

Asian Americans and Pacific Islanders, and Native

Americans—made up 45% of the over 3,200 individuals enrolled in the trial. The DPP, conducted at 27

centers nationwide, is the first major clinical trial 

to show that diet and exercise can effectively reduce

diabetes in a diverse American population of overweight people with pre-diabetes. The lifestyle intervention, which targeted a 7% (or an approximate 15

pound) weight loss, and 150 minutes of walking or

other moderate-intensity exercise per week, reduced

the risk of getting type 2 diabetes by 58% compared

to the control group, which received standard medical advice. The same study found that treatment

with metformin also reduces diabetes risk, though

by a less dramatic 31%, in people at high risk for

type 2 diabetes.

Long-term follow up studies are under way to

assess the durability of the DPP interventions in

preventing or delaying diabetes and to determine

whether the interventions reduce cardiovascular

disease and atherosclerosis, major causes of death

in people with type 2 diabetes. This study will 

also provide important information on the clinical

course of new-onset type 2 diabetes in this diverse

study population.

Continued Benefits of Improved Blood Sugar

Control: The Diabetes Control and Complications

Trial (DCCT)—a large, randomized, and controlled

clinical trial completed in 1993—definitively tested

the hypothesis that improved blood sugar control

prevents or delays complications in type 1 diabetes

patients. In a report on a follow-up study to the

DCCT, scientists demonstrated that the benefits of

strict blood sugar control first observed in the DCCT

persist for at least 7 years. When the DCCT trial

ended, both groups were encouraged to use intensive therapy and were closely monitored. Overall

blood sugar levels soon became similar in the two

groups--with better control in the former conventional group and looser control in the former intensive group. Despite their similar levels of control

during the subsequent 7 years, follow-up showed

that those who had initially been in the intensive

therapy group were still less likely to develop eye 

or kidney disease than those whose blood sugar 

was initially controlled using conventional therapy.
DMICC ANNUAL REPORT 47 FY 2002

This follow-up study, the Epidemiology of Diabetes

Interventions and Complications (EDIC) study, is

still ongoing. Using the DCCT closeout examination

results as a baseline for comparison, the scientists

found that patients initially in the intensive treatment group were less likely to develop retinopathy

and impaired kidney function than those in the conventional group. Individuals initially in the intensive treatment group were also less likely to develop

high blood pressure.

The DCCT results demonstrated that by strictly

monitoring and controlling their blood sugar, patients can significantly reduce their risks of developing complications. The new results from EDIC

show that the benefits of a finite period of stricter

blood sugar control persist for at least 7 years 

after levels of control were equalized. Because 

of this proven, persistent benefit, it is important 

to begin intensive treatment to control blood 

sugar as early as possible.

Diabetes Prevention Trial for Type 1 Diabetes (DPT-1):

In this major clinical trial, NIDDK-supported researchers tested the hypothesis that low dose insulin

injections can prevent type 1 diabetes in those 

most at risk–relatives of type 1 diabetes patients.

Although the study did not demonstrate a benefit for

this therapy in pre-diabetic patients, it did show

that it was possible to accurately identify individuals at very high risk for progression to type 1 diabetes and it set the stage for future studies through

a new clinical trial network, the Type 1 Diabetes

TrialNet. The ability to recognize the onset of autoimmunity before damage is sufficient to cause diabetes and to identify individuals likely to progress

to diabetes will be essential for the design of future

clinical trials to prevent type 1 diabetes.

A parallel trial, testing the efficacy of orally administered insulin for preventing the onset of type 1

diabetes in persons at increased risk (25-to-50 

percent risk of developing disease in 5 years), has

finished recruiting and analyses of its outcome is

expected in the Spring of 2003.

Type 1 Diabetes TrialNet: A consortium of investigators, clinical recruitment centers, and core 

support facilities has been established to perform 

intervention studies to preserve pancreatic beta cell

function in patients with new-onset type 1 diabetes

and to prevent type 1 diabetes in high risk individuals. TrialNet centers are completing the Diabetes

Prevention Trial for Type 1 Diabetes (described previously). Furthermore, TrialNet will design and 

execute pilot and expanded studies of new agents 

to prevent or ameliorate type 1 diabetes as well as

natural history and genetics studies in populations

screened for or enrolled in these studies. Fourteen

clinical centers and approximately 350 satellites

and sites affiliated with these centers throughout

the U.S. and Canada are participating in this consortium. The TrialNet will conduct studies in collaboration with the Immune Tolerance Network, a consortium of leading immunologists that is focused on

assessing methods to reprogram the immune system

to reverse autoimmunity in a number of autoimmune disorders, including type 1 diabetes.

Network for Type 2 Diabetes in Children and

Adolescents: To combat the rising epidemic of type 

2 diabetes in children, the NIDDK created a network

of investigators to develop trials for treatment of

type 2 diabetes in children and to develop and test

interventions to reduce their risk of developing type

2 diabetes. The majority of children with type 2 diabetes are in the pre-adolescent or adolescent age

range, a period that presents special challenges to

health care providers and families when attempting

to promote behavior and lifestyle changes. Prevention and treatment programs must also consider

cultural differences among racial and ethnic groups

that may influence acceptance of medical regimens.

This is especially important for type 2 diabetes 

in children, which disproportionately affects 

minority populations.
DMICC ANNUAL REPORT 48 FY 2002

In addition to those with frank diabetes, significant

numbers of children may be at high risk of developing diabetes based on the presence of insulin 

resistance and blood glucose levels above normal

but not as high as in diabetes. The Network for 

Type 2 Diabetes in Children and Adolescents is developing a prevention trial protocol that will focus 

on cost-effective, school-based interventions to

decrease risk factors for type 2 diabetes and thus

lower the incidence of this disease in children and

adolescents. It is anticipated that the prevention

strategies developed and tested will have the potential for broad, population-wide application.

To address its other major research goal, the Network will design trials to identify appropriate and

effective treatment regimens for type 2 diabetes in

children. The drugs currently available for the treatment of this disease in adults have not been used

widely in children. Treatment options, including

lifestyle changes and pharmacologic therapy, need

to be studied in this population to determine the

most efficacious, safe, and cost-effective strategies

to achieve and maintain near normal blood glucose

levels in the pediatric age group. Such treatment

strategies are essential for reducing the long-term

progression to diabetic complications for those who

were diagnosed with diabetes during childhood and

are at particularly high risk due to early development, and therefore longer duration, of their disease.

Obesity–Critical in Diabetes and a Major Problem

of its Own: The number of overweight and obese

Americans has risen dramatically in the past two

decades and is now at epidemic levels. Obesity is 

a major risk factor for numerous serious diseases,

including type 2 diabetes, heart disease, and cancer.

Approximately 80 percent of the type 2 diabetes in

the U.S. occurs in overweight or obese individuals.

Overweight and obesity disproportionately affect

minority populations, particularly African American,

Hispanic, and Native American women and children.

NIDDK-supported investigators are working to elucidate the molecular factors that control appetite,

metabolism, and energy storage, and are identifying

potential targets for the development of new pharmacological agents to promote safe, long-term

weight loss. As demonstrated recently by the landmark Diabetes Prevention Program (DPP), a five 

to seven percent sustained reduction in weight–

achieved through modest changes in diet and exercise--can delay or prevent the onset of diabetes

in a high risk population. Investigators are continuing behavioral research like that employed in the

DPP, to help people achieve lifestyle modifications

that include increased physical activity and

improved diet.

The NIDDK maintains a strong program of research

on and related to obesity, both as a serious risk factor for type 2 diabetes and its complications and as

an independent health problem. The National Task

Force on the Prevention and Treatment of Obesity

was established by the NIDDK and includes both

NIH scientists and experts from the extramural

community. This Task Force provides science-based

guidance to aid research strategies. The Task Force

also generates public health messages about obesity. The Director of NIDDK recently created the Office

of Obesity Research within the Institute to coordinate obesity research across the many Institutes

and Centers of the NIH. The NIDDK also supports

Obesity/Nutrition Research Centers and Clinical

Nutrition Research Units, which conduct both 

basic and clinical research studies.

Look AHEAD: Action for Health in Diabetes: With

support from other NIH Institutes and Centers, the

NIDDK has launched Look AHEAD—a multi-center

clinical trial that will examine the health effects 

of intentional weight loss in 5,000 obese diabetic

patients, with particular emphasis on cardiovascular health. Enrollment, begun in June 2001, is now 

at the halfway point at 16 Look AHEAD Clinical

Centers and a Data Coordinating Center. Trial participants, who will be followed for up to 11.5 years,

are randomly assigned to one of two protocols, the

Lifestyle Intervention, which is designed to help

participants achieve and maintain weight loss over

the long term, or Diabetes Support and Education.
Translating the Results of Clinical Research into

Clinical Practice: The past few years have seen

encouraging progress in development of effective

new treatments for diabetes. Now, a key challenge 

is to ensure the American people benefit from what

researchers have discovered. One approach to this

challenge is education—dissemination, to those at

risk and their care providers, of information about

measures proven effective for treating type 1 and

type 2 diabetes and for preventing type 2 diabetes 

in individuals at high risk for this disease. However,

providing information alone is not sufficient to

translate what we know into practice. We need to

develop methods to take interventions that have

been demonstrated to be beneficial in careful clinical investigations, and extend or adapt them to 

larger populations or other settings. There is also

increasing recognition that behavioral factors play 

a major role in the increased prevalence of obesity

and type 2 diabetes and in the management of 

diabetes and its complications.

National Diabetes Education Program (NDEP): The

NDEP is a collaborative initiative of the NIDDK and

the CDC that uses over 200 public and private partnerships to promote, through education, routine

clinical application of the therapies and other activities that have demonstrated value in the prevention

of type 2 diabetes and diabetic complications. A key

feature of this program is the participation of individuals who represent communities such as African

Americans, Hispanics/Latinos, Native Americans/

Alaska Natives, and Asian and Pacific Islanders who

are disproportionately affected by type 2 diabetes.

Among its many educational efforts, the NDEP is 

the primary mechanism for translating the striking

results of the DPP into real health improvements for

the public.

A new national diabetes prevention campaign,

launched on November 20, 2002, by HHS Secretary

Tommy Thompson, will be coordinated by the NDEP.

The program, entitled “Small Steps, Big Rewards,”

represents the first major NDEP effort to translate

the DPP results on a national level, and its message

is targeted at the 16 million Americans most at

risk—those with pre-diabetes. The program emphasizes the practical application of the DPP findings

and includes lifestyle-change tools for those at risk,

patient education materials for healthcare providers

and consumers, and TV, radio and print public 

service announcements.

While working to increase awareness about diabetes

and effective means for prevention, the NDEP is 

continuing a core campaign, “Be Smart About Your

Heart: Control the ABC’s of Diabetes.” This campaign

is designed to make people with diabetes aware of

their high risk for heart disease and stroke—the

leading cause of death in these patients—and the

steps they can take to dramatically lower that risk.

The campaign emphasizes not only managing blood

glucose, but also blood pressure and cholesterol.

The National Kidney Disease Education Program:

This new program will raise awareness of the 

seriousness of kidney disease and the importance 

of early diagnosis, and increasing implementation 

of the appropriate management and prevention

strategies for the disease and its complications.

The number of people with end-stage renal disease

has doubled each decade for the last two decades.

These increases appear to parallel the rising prevalence of diabetes, the leading cause of kidney disease. Clinical trials have shown that optimal 

management of diabetes and blood pressure can

reduce onset and progression of kidney disease.

DMICC ANNUAL REPORT 49 FY 2002
DMICC ANNUAL REPORT 50 FY 2002

Behavioral Research—Key to Prevention and

Treatment of Diabetes: Recent clinical trials have

provided definitive evidence that type 2 diabetes 

can be prevented with lifestyle change and that rigorous control of blood glucose, blood pressure and

lipid levels can delay or prevent diabetes complications. Yet, this control can be arduous—requiring

adherence to a complex regimen of medications, diet

and physical activity–and it is optimal in very few

Americans with this disease.

In response to the needs in this research area, the

NIDDK has acted to stimulate application of behavioral science to diabetes through multiple initiatives. One solicitation called for research related to

sociocultural, environmental, and behavioral mechanisms that contribute to successful self-management of diabetes. A subsequent solicitation specifically addressed diabetes self-management in the

minority populations who are disproportionately

affected by diabetes and its complications. A broader NIH-wide solicitation addressed the clarification

of disease-relevant social and cultural factors and

the linking of behavioral research to practices for

improved prevention and treatment. More targeted

research has focused on the role of psychological

disorders--such as depression and eating disorders-

-on the risk of developing diabetes and its complications. People with diabetes have twice the rates of

depression seen in the general population; moreover,

people with depression have increased prevalence 

of diabetes. An NIH conference focused on research

issues in depression in diabetes and other selected

chronic diseases; this was followed by a solicitation

to increase research on the relationships among

depression, eating disorders, diabetes and obesity,

and to explore how treatment of psychological disorders may improve outcomes in diabetes.

Translational Research for the Prevention and

Control of Diabetes: Sadly, advances from “gold 

standard” clinical trials on therapy of diabetes 

and prevention of its complications have not been

successfully incorporated into general health care

practice. Under-utilization of current knowledge 

was highlighted in a recent study of individuals

with diabetes that demonstrated a low frequency 

of self-monitoring of blood glucose, good glycemic

control, regular foot care, and ophthalmic examinations, all of which markedly reduce the development and progression of diabetic complications.

With the demonstration that modest lifestyle

changes can dramatically reduce the risk of developing type 2 diabetes in high risk individuals comes

the imperative to develop both population-based

and clinic-based strategies to establish cost-effective programs to identify individuals at high risk

who could benefit from prevention programs and/or

successfully promote lifestyle change. Additional

research is also needed on improved methods of

health care delivery to patients with diabetes and 

to compare the effectiveness and use of different

clinical practices, interventions, and technologies 

in particular population subgroups. These opportunities are being explored through new Diabetes

Prevention and Control projects.

Diabetes-Based Science Education in Tribal 

Schools (DETS): American Indian and Alaska Native

communities have the highest rates of diabetes in

the world. Using the network of Tribal Colleges and

Universities, the DETS program is developing supplemental curricula for Tribal elementary, middle

and high schools to instruct students about lifestyle

changes that can dramatically reduce the risk of

diabetes and to encourage them to prepare for 

biomedical careers.

Strengthening Research Talent in Diabetes:

Solving the puzzle of diabetes will require a cadre 

of exceptionally talented and dedicated researchers.

To that end, a number of specific new initiatives

were developed to recruit, train, and support new

diabetes research talent.
DMICC ANNUAL REPORT 51 FY 2002

Attracting New Talent to Diabetes Research: An

innovative partnership program is promoting collaboration among diabetes researchers and those 

in areas other than diabetes who have expertise or

technology that could advance diabetes research

projects. This program was initiated with the special

type 1 diabetes funding, using the diabetes centers

as a catalyst to bring researchers together from 

disparate components of institutions for collaborative, multi-disciplinary research relevant to problems associated with type 1 diabetes. Subsequently,

the program was expanded to investigators at all

institutions. The goal is to encourage diabetes researchers to act as “talent scouts” to identify other

researchers who could contribute to research breakthroughs in diabetes.

Bringing Together Basic and Clinical Researchers: 

An innovative program supports collaboration

between basic research scientists, whose findings

have potential direct applicability to development 

of new treatments or diagnostic tests, and clinical

scientists, who can help to translate these basic 

discoveries into pre-clinical or clinical trials. The

special type 1 diabetes funding allowed this program to be initiated with a focus on type 1 diabetes

and diabetes complications. If successful, this

bench-to-bedside research program will be expanded to all forms of diabetes.

Developing Clinical Researchers for Childhood

Diabetes: In collaboration with the ADA and the

JDRF, the NIH is intensifying efforts to expand 

the cadre of pediatric endocrinologists pursuing

research careers. A new program addresses a critical

shortage of clinical researchers in the important

field of childhood diabetes. This effort will support

a combination of complementary programs at institutions with particular strength in pediatric diabetes research. These combined programs will support development of new researchers by providing 

research training during pediatric endocrinology fellowships followed by a special career development

award framed to provide research support for individuals who have completed their research training

and have dedicated themselves to becoming independent clinical researchers.

National Institute of Environmental Health

Sciences (NIEHS)

Many environmental agents have been investigated

as contributing to the risk of type 1 diabetes.

Environmental components have been suggested

because concordance rates between identical twins,

where one twin has type 1 diabetes, remain at 30-

50%. NIEHS is pursuing research in several areas 

relevant to the etiology of type 1 diabetes, as summarized below.

Current Activities

Recent studies have raised the possibility that 

certain chemicals in the environment, such as

nitrates in well water, increase the risks of juvenile

diabetes. Studies in the United Kingdom, Finland,

and Colorado indicate that the incidence of childhood diabetes is higher in areas with elevated levels

of nitrate in the drinking water. This finding is 

significant for agricultural communities because

well water can have elevated nitrate levels in areas

where there is extensive use of fertilizers. Current

and future activities in this area by NIEHS intramural scientists include.

• Further investigation of the possible association

between nitrates and juvenile diabetes in a rigorous prospective study, such as the Agricultural

Health Study.

• Evaluation of diabetes along with other health 

outcomes in the Agricultural Health Study.
DMICC ANNUAL REPORT 52 FY 2002

In other studies, intramural investigators at NIEHS

have reported an association between the body burden of a persistent organic pollutant (polychlorinated biphenyls) and type 1 diabetes. Current and

future studies in this area include. Further studies 

to examine the relation between diabetes and body

burden of persistent organic pollutants are either

underway or being planned. For example, DNA is

being collected from a cohort of men so that polymorphisms in the Ah-receptor (binds with dioxinlike polychlorinated biphenyls) can be examined in

relation to body burden of persistent pollutants and

risk of diabetes.

In extramural studies supported by the NIEHS,

investigators are studying the possibility that

arsenic in drinking water causes an increase in 

diabetes risk. Elevated levels of arsenicals in drinking water are common throughout the world, and

oxidative forms of arsenic are known to have cytotoxic effects. These studies will:

• Investigate the effects of trivalent arsenicals 

and related compounds on glucose-stimulated

insulin secretion in pancreatic islets and cell 

culture systems.

• Examine the effects of these compounds on insulin

sensitivity in insulin-sensitive peripheral tissues

and in intact animals.

Other extramural research efforts are examining the

contributions of stress-activated protein kinases to

insulin resistance and type 2 diabetes and the mechanisms of action of xenobiotic beta-cell toxins in

animal models.

As noted above, the intermediate concordance 

rates for type 1 diabetes have stimulated the search 

for contributing environmental factors. Current 

and future activities in this area by intramural

investigators include:

• In collaboration with investigators in the United

Kingdom, NIEHS is investigating the hypothesis

that persistant materno-fetal michrochimerism

influences the development of type 1 diabetes in 

a set of monozygotic twins discordant for type 1

diabetes.

• NIEHS is investigating the possibility of establishing a discordant monozygotic twin registry in the

United States for twins with type 1 diabetes, so

that prospective studies of at-risk twins can be

carried out.

Recent findings by intramural investigators using

knockout mice have identified the guanine nucleotide

regulatory or G protein G0 as an important regulator

of glucose tolerance and glucose-stimulated insulin

secretion in mice. Future studies will involve:

• Investigations into the molecular nature of the

enhanced glucose tolerance seen in the intact mice.

• Studies of the molecular mechanisms of the

enhanced glucose-stimulated insulin secretion

seen in isolated islets from the G0 knockout mice.

NIEHS investigators are also investigating the role 

of menstrual and reproductive risk factors in diabetes and are looking at mechanisms of how environmental agents can affect pancreatic cancer cells.
DMICC ANNUAL REPORT 53 FY 2002

National Institute of General Medical Sciences

(NIGMS)

The National Institute of General Medical Sciences

supports research and research training in the basic

biomedical sciences that provide the foundation for

a better understanding of fundamental life processes. Some of this work has relevance to understanding

and treating diabetes.

Current Activities

NIGMS supports the Human Genetic Cell Repository,

a collection of over 7,900 cell lines from individuals

with a wide variety of genetic disoders, including

diabetes, and from normal individuals. Cell lines in

the collection include those from individuals with

both type 1 and type 2 diabetes mellitus and its

complications. The repository includes an extensive

collection of cell lines from members of an extended

pedigree with maturity-onset diabetes of the young.

This collection is of value in studies designed to 

map and characterize the gene(s) responsible for

these disorders.

DNA is also available for many of the cell lines in 

the Human Genetic Cell Repository. In new initiatives, the Repository has obtained two large panels

of cell lines collected from individuals in ethnically

identified, minority populations within the United

States. These new collections supplement the panels

of cell lines from 500 unrelated individuals that were

acquired earlier, in cooperation with the National

Human Genome Research Institute, in order to facilitate analyses of the genetic diversity of the U.S. population. This resource has proven to be of great value

to researchers for the discovery of DNA polymorphisms important in pharmacogenetic studies and in

the identification of genes involved in complex genetic disorders such as diabetes. The NIGMS Human

Genetic Cell Repository will continue to cooperate

with the National Human Genome Research Institute

in the collection of cell lines from around the world

for the HapMap project.

NIGMS has an interest in understanding how genetic

and environmental components interact to result 

in complex diseases such as diabetes. The Institute

supports a portfolio of grants to develop better 

statistical methods for mapping and identifying

genes underlying complex traits, develop mathematical models for studying gene-gene and geneenvironment interactions, investigate DNA sequence

variation and its evolution, examine gene activities

and the consequences of abnormalities in these

activities, and optimize sampling strategies. NIGMS

also supports pre- and postdoctoral training that

emphasizes statistical and computational skills 

and workshops to provide additional training in 

statistical methods to biologists.

NIGMS support for research on the mechanisms

underlying individual variations in drug response,

while not specifically targeting diabetes, has the

potential to have an impact on the treatment of diabetes and its complications. Researchers are studying the structural features of a powerful peripheral

vasodilator related to insulin identified as an important prospective drug for peripheral angiopathies

associated with diabetes.

NIGMS, in conjunction with several other Institutes,

is supporting a mouse mutagenesis and phenotyping

center whose emphasis is the high-throughput generation and identification of mice with mutations in

biochemical and developmental pathways that may

prove useful as models for human diseases.

NIGMS is also participating in the Trans-NIH

Zebrafish Initiative, whose goal is to improve 

the genomic resources for the zebrafish, another 

potentially valuable model for diabetes studies.
DMICC ANNUAL REPORT 54 FY 2002

Future Activities

In the future, NIGMS will continue to support basic

research that focuses on underlying mechanisms and

principles that are expected to shed light on both

normal and disease processes and to lead to the development of new modes of treatment and prevention.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health supports

research on the processes and mechanisms underlying co-morbid mental disorders and diabetes. It 

also supports research to develop and test preventive, treatment, and rehabilitative interventions 

for mental disorders in people with diabetes. The

interventions may be pharmacologic, behavioral,

or psychosocial.

Current Activities

In FY 2000–2001, NIMH and the National Institute 

of Diabetes and Digestive and Kidney Diseases cosponsored a major research conference, "Depression

and Mental Disorders in Patients With Diabetes,

Renal Disease, and Obesity/Eating Disorders," on

January 29–30, 2001 at the Natcher Conference

Center, National Institutes of Health. The papers

resulting from the conference have been published 

in a 2002 special issue of the Journal of Psychosomatic Research (October 2002; 53(4)). The two

Institutes jointly released a Request for Applications

with a set aside of $1.5 million to fund new research

projects in 2002. The NIMH supported two applications with its available funds.

In addition, NIMH re-issued in 2002 its program

announcement calling for research applications 

on co-morbid mental and physical disorders, including diabetes.

National Institute of Neurological Disorders 

and Stroke (NINDS)

The National Institute of Neurological Disorders and

Stroke supports a portfolio of research to study neurological complications of diabetes. Over 60% of people with diabetes are affected by neuropathy, and in

many patients symptoms such as pain, numbness,

weakness, or even paralysis are serious enough to

interfere with daily activities. Symptoms of diabetic

autonomic neuropathy can include heart rate abnormalities, hypertension, dizziness, digestive disturbances, and impotence. Autonomic neuropathy is an

important cause of sudden cardiac death in people

with diabetes. Prevention and treatment of neurological complications is a central therapeutic problem

in diabetes mellitus, and research is conducted in

such diverse areas as metabolism, sensory disorders,

impaired wound healing, hypoglycemia, and pain.

Current Activities

NINDS has participated in nine initiatives related 

to the special type 1 diabetes appropriations, three

as the lead institute. As the result of three Request

for Applications published each year between FY

1998 and FY 2000, NINDS has greatly expanded its

research into neurological complications of diabetes.

New areas of study include early detection of diabetic neuropathy, gene transfer for prevention of neuropathy, autonomic neuropathy, behavioral effects of

hyperglycemia, and mechanisms of neuropathic pain.

Several new NINDS applications were funded from

two new FY 2002 RFAs. Applications in response to

the RFA “Surrogate Endpoints for Diabetic Microvascular Complications” are looking for ways to

detect early signs of diabetic neuropathy. Applicants

whose grants were in response to the RFA “Effects of

Hypoglycemia on Neuronal and Glial Cell Function” are

studying mechanisms that may explain hypoglycemia’s

effect on cells in the central nervous system.
DMICC ANNUAL REPORT 55 FY 2002

NINDS continues to support a large epidemiological

study of neurological complications of diabetes in

the Rochester, Minnesota, area in the Caucasian and

Mdewakanton Dakota Native American populations.

Future Activities

In addition to the Caucasian and Mdewakanton

Dakota Native American populations, the Rochester

epidemiological study will be expanded to include

Hispanic subjects. Diabetes is characterized by large

disparities in prevalence among ethnic groups, but

little is known about the extent of neurological complications in these populations. This study will be

the first to document the extent and progression of

neurological complications in a longitudinal multiethnic cohort. Additional studies of this type have

been solicited in a new jointly issued Program

Announcement, “Race/Ethnic Disparities in the

Incidence of Diabetes Complications” (PA-02-165).

National Institute of Nursing Research (NINR)

The mission of the National Institute of Nursing

Research is to support clinical and basic research to

establish a scientific basis for the care of individuals

across the lifespan—from management of patients

during illness and recovery to the reduction of risks

for disease and disability, the promotion of healthy

lifestyles, the improvement of quality of life in those

with chronic illness, and care for individuals at the

end of life. One purpose of this research, specific to

diabetes, is to understand how to promote healthsustaining behavior and to improve quality of life by

relieving the effects of disease processes and their

progression. Nursing research focuses on how physical and psychological responses to diabetes symptoms and treatment of the disease affect health

throughout the lifespan. NINR research programs

pay particular attention to the effect of diabetes in

minority and underserved populations.

Current Activities

NINR joined one new and one reissued program

announcement (PA) in FY 2002: “Race/Ethnic

Disparities in the Incidence of Diabetes Complications” and “Translational Research for the

Prevention and Control of Diabetes,” respectively.

Additionally, NINR continued to encourage research

in this area with three ongoing program announcements: “Enhancing Adherence to Diabetes SelfManagement Behaviors”, “Diabetes Self-Management

in Minority Populations”, and “Self-Management

Strategies Across Chronic Diseases.” These PAs are

consistent with Diabetes Research Working Group

(DRWG) recommendations (NINR was a participant

in this working group).

In response to increased congressional support 

for type 1 diabetes research, NINR joined three

requests for applications issued in FY 2002: “Innovative Partnerships in Type 1 Diabetes Research”,

“New Approaches To Prevent Hypoglycemia in Patients with Diabetes”, and “Understanding Hypoglycemia Unawareness in Patients with Diabetes.”

Funded grants relating to diabetes research included

career development, postdoctoral training, and

investigator-initiated research. Diabetes-specific 

topics included ethnic variations in type 2 diabetes

prevention knowledge, adolescents with type 1 and 

2 diabetes, autonomy and self-care in adolescents

with type 1 diabetes, Spanish language self-management programs, biobehavioral intervention studies

in several ethnic groups, a description of the integration of diabetes self-care in Mexican-Americans with

type 2 diabetes in the southwest, an intervention 

for parents of young children with newly diagnosed

diabetes, biophysical determinants of diabetes foot

ulcer healing, weight loss in diabetes, and children’s

response when a sibling has type 1 diabetes.
DMICC ANNUAL REPORT 56 FY 2002

Future Activities

NINR plans to continue to support research that

focuses on problems experienced by persons with

diabetes. Research efforts will be guided by the 

following goals:

• FY 2003: NINR will work collaboratively with

other Institutes and organizations to increase 

and facilitate diabetes research activities.

• FY 2004: NINR plans to focus support on promising ongoing and new diabetes research areas,

while building on recent nursing science advances.

In summary, NINR activities are designed to support

research related to interventions for persons with

diabetes, self-management, quality of life, special

and diverse population needs, problems of defined

age groups and across the lifespan, basic research,

genetics, and other initiatives relevant to clinical

practice and client outcomes. Translation of 

advances of science to the practice setting will 

be encouraged.

National Institute on Aging (NIA)

The mission of NIA as it relates to diabetes is to

support biomedical and behavioral research leading

to improved therapies to prevent diabetes and its

complications, as well as improved quality of life 

for older diabetic patients.

Current Activities

NIA continues to support studies of potential 

metabolic mechanism(s)/factors that contribute 

to and/or underlie deleterious changes in body composition that can lead to metabolic disorders in old

age. Ongoing studies in animal models have demonstrated a cause-and-effect relationship between 

visceral fat and major components of the metabolic

syndrome. Surgical removal of visceral fat in aging

(20-month-old) F344/Brown Norway (FBN) and in

Zucker Diabetic Fatty (ZDF) (accounting for approximately 18% of their total body fat) rats was sufficient

to restore peripheral and hepatic insulin action to

the levels of young rats. While removal of visceral fat

in ZDF rats prevented the progressive decrease in

insulin action and delayed the onset of diabetes, it

did not alter plasma-free fatty acid levels. This data

suggest that insulin resistance and the development

of diabetes can be significantly reduced in aging rats

by preventing the age-dependent accumulation of

visceral fat.

An NIA-supported project examined aging rats that

underwent calorie restriction throughout their lives,

maintaining their youthful body fat pattern and

metabolic profile in order to examine whether leptin's failure in aging is due to aging per se or to

changes in body fat mass or distribution. As assessed by a number of parameters of leptin action, it

appears that the age-related decline in leptin action

is independent of the body fat pattern. Leptin's failure in this model suggests a possible causative role

in the metabolic decline seen with aging.
DMICC ANNUAL REPORT 57 FY 2002

Numerous studies in laboratory animals have shown

that chronic caloric restriction (CR), i.e., limiting

caloric intake below ad libitum levels, extends maximum and average lifespan by as much as 40% and

delays age-related pathologies correspondingly. CR

increases life span whether initiated in early adult

life or middle age, but its effects diminish with

increasing age of onset of CR. The amount of lifespan extension increases with the degree of caloric

restriction (up to approximately 40% restriction);

substantial effects have occurred with 20% restriction. Among the aging, changes slowed by these regimens are declines in glucose tolerance and insulin

sensitivity and increases in body weight.

Chronic CR in nonhuman primates has been found 

to produce parallel physiologic changes to those

seen in rodents; studies of its effects on nonhuman

primate lifespan have not been completed. To evaluate the effects of CR interventions in humans, NIA

recently initiated the group of U01 projects known as

CALERIE (Comprehensive Assessment of Long-Term

Effects of Reducing Intake of Energy). CALERIE consists of exploratory controlled human intervention

studies on the effects of CR interventions on physiology, body composition, and risk factors for age-related pathologies in non-obese persons. The CALERIE

clinical sites and respective Principal Investigators

include: Washington University, St. Louis, John

Holloszy, M.D (PI); Pennington Biomedical Research

Center, Eric Ravussin, Ph.D. (PI); and Tufts University, Susan Roberts, Ph.D.(PI). The CALERIE Coordinating Center is located at Duke Clinical Research

Institute, James Rochon, Ph.D. (PI).

NIA was a cosponsor of the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

study, Diabetes Prevention Program (DPP).

NIA was a cosponsor of the NIDDK Request for

Application (RFA DK-03-002) “The Life Cycle of the

Adipocyte.” Application receipt date is March 13,

2003. Awards will be issued at the end of FY 2003.

NIA was a cosponsor of the National Heart, Lung

and Blood Institute (RFA HL-03-008) “ Role of Sleep

and Sleep-Disordered Breathing (SDB) in Metabolic

Syndrome.” This RFA seeks to develop a better understanding of relationships between sleep deprivation,

SDB, and the metabolic syndrome with the goal of

reducing the risk of cardiovascular complications

and age-associated pathologies. Application receipt

date was February 11, 2003.

National Institute on Alcohol Abuse 

and Alcoholism (NIAAA)

The National Institute on Alcohol Abuse and Alcoholism encourages research to understand the role

of alcohol consumption as a risk factor in the development of diabetes mellitus. NIAAA also supports

research to determine the effects of moderate alcohol

consumption on diabetes. Several studies suggest

that alcohol consumption may directly or indirectly

contribute to the development of type 1 diabetes.

This line of reasoning is based on the following

observations: a) alcohol impairs pancreatic insulin

secretion; b) chronic alcohol intake increases plasma

TNF (tumor necrosis factor) levels, which have been

shown to cause pancreatic beta cell apoptosis leading to decreased beta cell number and insulin secretion; and c) chronic alcohol consumption may impair

beta cell function by eliciting immunotoxicity.
DMICC ANNUAL REPORT 58 FY 2002

Chronic alcohol consumption also has been implicated in the development of type 2 diabetes based on

the following findings: a) chronic alcohol feeding in

rats reduces the number of insulin-binding sites 

on isolated hepatocytes; b) alcohol impairs insulinmediated tyrosine phosphorylation of insulin receptors in a tumor cell line; c) chronic alcohol exposure

blunts tyrosine phosphorylation of insulin receptor

substrate-1 in rat hepatocytes and a tumor cell line;

and d) chronic alcohol exposure inhibits the activity

of rat hepatocyte phosphotidylinositol-3kinase, which stimulates glucose transport. These effects of

alcohol may lead to insulin resistance and impaired

glucose transport.

Current Activities

Currently, NIAAA supports three projects that investigate the relationship between alcohol intake and

diabetes. The following research areas are under

investigation:

• Impact of moderate alcohol consumption on the

risk of diabetes mellitus.

• Effects of fetal alcohol exposure on the biochemical and physiological changes in the insulin

response and glucose homeostasis.

• Molecular mechanisms of disruption of insulinmediated glucose transport by ethanol.

Future Activities

NIA has on going initiatives to build up our portfolio

on the interaction between alcohol consumption and

diabetes mellitus and tissue injury.

NIA is planning to hold a workshop on Alcohol and

Diabetes in FY 2003.

National Institute on Deafness and Other

Communication Disorders (NIDCD)

Disorders of hearing, balance, smell, taste, voice,

speech, and language exact a significant economic,

social, and personal cost for many individuals. The

mission of the National Institute on Deafness and

Other Communication Disorders is to support and

conduct research and research training in the normal processes and the disorders of human communication that affect many millions of Americans.

NIDCD supports basic and clinical research on diabetes mellitus in the area of taste. Taste preferences

for sweet-tasting substances play a crucial role in

the development of insulin and non-insulin dependent diabetes.

Current Activities

NIDCD is supporting research on taste and endocrine factors in women with gestational diabetes.

Gestational Diabetes Mellitus (GDM) is a common

complication of pregnancy with serious consequences for maternal and child health. Diet is an

integral part of the management of GDM, but current

diet strategies for pregnant women with GDM are

poorly defined and often fail. NIDCD-supported 

scientists have observed that GDM increases the

preference for sweet taste and dietary intake of

sweet foods, which could have important implications for the management of this disease. At the 

time of diagnosis (approximately 30 weeks gestational age), pregnant women with GDM showed a

higher preference for sweetened dairy drinks compared to pregnant women without GDM. In addition,

increased plasma glucose in women with GDM was

related to higher preference for the sweet taste of

glucose and higher dietary intake of simple sugars

as fruit and fruit juices. Because these studies were

limited to a single observation point during gestation

and excluded women with severe diabetes or those

treated with insulin, further studies are needed.
DMICC ANNUAL REPORT 59 FY 2002

The specific aims of this project are: 1) to determine

the relationship between hyperglycemia and increased taste preference and dietary intake of sweet foods

in GDM, 2) to compare the temporal pattern of taste

and dietary changes in women with GDM to those 

of women without GDM across pregnancy stages,

and 3) to relate these taste changes to alterations in

gestational hormone and metabolic profiles. A single

prospective study will be conducted to measure

sweet taste preferences, food cravings, dietary intake

of sweet foods, and plasma indices of selected hormones and metabolites (including insulin, cortisol,

and leptin) during early, middle, and late gestation

and at 6-week and 20-week post-delivery. The longterm goal of this project is to obtain a better understanding of taste changes in women with GDM to

develop better preventative and therapeutic dietary

intervention strategies for this disease.

National Institute on Drug Abuse (NIDA)

A study on glucose metabolism disorders in HIVinfected drug abusers will be considered for funding

in FY 2003. Further, the proceedings of a workshop

on "Interventions for Metabolic and Endocrine

Complications of HIV/AIDS and Drug Abuse,” guestedited by Jag Khalsa, Sander Genser, and Henry

Francis of the Center on AIDS and other Medical

Consequences of Drug Abuse, NIDA, has been accepted as a special supplement volume in the Clinical

Infectious Diseases journal.

National Library of Medicine (NLM)

NLM explores the use of new information technologies to enable diabetes patients to manage their 

disease and avoid or delay the onset of costly and

debilitating complications, especially patients from

minority and medically underserved populations.

In particular, we seek to learn how the use of NLM’s

MEDLINEplus Web site, and other computer-based

health information resources, can be helpful to patients, their families, and members of the public to

learn about and understand the latest research news

on diabetes, nutritional requirements, tests, devices,

secondary prevention techniques, and for obtaining

answers to patient-specific questions. In the clinical

setting, the principal hypothesis is that MEDLINEplus can reinforce and supplement the information

provided by physicians, nurses, and health educators. A related hypothesis is that a combination of

individualized training and access to publicly available computer resources at hospital libraries and

elsewhere in the community can help bridge the

“digital divide” experienced by minority populations

that have less ready access to computers in the home,

school, and workplace than the majority population.

Current Activities

NLM’s diabetes-related objectives are to develop,

design, implement, and evaluate a comprehensive

program of diabetes-focused outreach initiatives in

collaboration with academic health science centers

and libraries, clinical centers, community-based

organizations, and voluntary health organizations.

Project A. In collaboration with the Naomi Berrie

Diabetes Center at Columbia/Presbyterian Hospital

in New York City, study the benefits of MEDLINEplus

and the Center’s own Web site with Hispanic and

African-American teenage type 1 diabetes patients

who are on the insulin pump. These new resources

are intended to reinforce and supplement the information provided by the Center’s physicians,
DMICC ANNUAL REPORT 60 FY 2002

nutritionists, and educators. The Center is also working with the medical informatics department at

Columbia to build a type 1 diabetes module for a

promising telemedicine system now under development for patients and hospital staff.

Project B. In collaboration with the Childrens 

Hospital of Los Angeles and the University of Utah

School of Medicine, study how a diverse patient 

population, including Hispanic and African-American teens and the families of newly diagnosed type

1 patients can benefit from using MEDLINEplus 

to learn about and understand the latest research

news, nutritional requirements, and uses of new

medical devices for promoting better diabetes management and control.

Project C. In collaboration with two churches 

serving the African-American community in Montgomery County, Maryland, experiment with the 

concept of “peer tutors” as a means to recruit teenagers at risk for type 2 diabetes; enhance their 

diabetes knowledge with the use of MEDLINEplus;

and observe changes in risk behaviors by them and

by their peers.

Project D: Enhance the usability of MEDLINEplus 

for Spanish-speaking users by developing a Spanish

language version of the more than 500 health topics,

patient tutorials, medical encyclopedia, and drug

information database and evaluate its acceptance

among diabetes patients.

Project E. In collaboration with the University of

Texas Health Science Center at San Antonio, and its

regional health center and clinics in the Lower Rio

Grande Valley, study how a computer workstation

installed in the clinic waiting room can provide

Hispanic patients with diabetes-related information.

Health care providers will encourage use of MEDLINEplus with special information referral prescription pads.

.Project F. Explore with the Juvenile Diabetes Research Foundation (JDRF) a variety of mutually supportive uses of new information technologies. These

include enhancement of NLM’s MEDLINEplus diabetes content for children and teens; user evaluations of MEDLINEplus; inclusion of JDRF-sponsored

trials in NLM’s ClinicalTrials.gov database; creation

of Spanish language resources based on JDRF’s

Countdown research magazine; experimentation

with informatics tools to lessen the probability 

of misdiagnosis of type 1 diabetes, particularly in

emergency departments serving minority and other

medically underserved populations; and experiment

with informatics and distance education tools for science teachers and nurses in low-income high schools.

Veterans Health Administration (VHA),

Department of Veterans Affairs

The mission of the Veteran's Healthcare System is to

serve the needs of America's veterans by providing

primary care, specialized care, and related medical

and social support services. To accomplish this mission, VHA needs to be a comprehensive, integrated

healthcare system that provides excellence in healthcare value, excellence in service as defined by its

customers, and excellence in education and research,

and it needs to be an organization characterized by

exceptional accountability and by being an employer

of choice.

The mission of the VHA diabetes program is to

improve the health of veterans with diabetes by

decreasing the incidence of adverse health outcomes,

especially macrovascular and microvascular disease.

This will be accomplished through systems-level

integration of guidelines, performance measurements, and data feedback to promote the increased

use of evidence-based preventive and treatment

processes. VHA research service supports this mission through clinical, basic science, and health 

services research. VHA reports the following

progress in FY 2002.
DMICC ANNUAL REPORT 61 FY 2002

Current Activities

Performance Measurement (Office of Quality and

Performance, OQP). In FY 2002,VHA, through its

External Peer Review Program, collected data from 

a random sample of 23,561 charts of veterans with

diabetes. A patient, to be established in the “plan,”

(not just enrolled as a veteran) must have accessed

VHA for any type of care some time at least once 2

years ago and at least once during the previous 12

months. OQP data analysis showed that the percentage of patients having chart documentation of the

following Diabetes Quality Improvement Project

(DQIP) measures using DQIP abstraction criteria

within 12 months (or as noted) of chart review is 

as follows: 

• HbA1c test (94%); 78% of HbA1c values less than

9%; 65% less than 8.0%; 41% less than 7%, and 17%

greater than 9.5% (for less than 9.5% the results

are 87%).

• Lipid profile within 2 years 94%; 70% less than 130

mg/dl, 64% of LDL-C values less than 120 mg/dl,

43% less than 100 mg/dl.

• Blood pressure control, 58% less than 140/90.

• Dilated retinal examination (72%).

• Nephropathy screening within 2 years (78%).

• Visual examination of feet 92%; palpation of pedal

pulses 86%; sensory examination of feet 82%; referral of patients with “high risk feet” to a foot care

specialist 84%.

Since VHA uses DQIP measures, comparison to the

private sector is possible. In FY 2001, VHA national

adherence to most measures was at the 90th percentile of the individual private sector plans, included in the National Committee on Quality Assurance

(NCQA) Quality Compass Report.

VHA Diabetes Registry (Office of Policy and Planning). The VHA has developed a nationwide diabetes

registry derived from administrative data. Veterans

are identified as having diabetes using one inpatient

or two outpatient codes with a diabetes-specific 

code or receipt of an oral agent or insulin. The denominator is defined as veterans who had at least

one clinical visit during the year. For FY 2001 

there were 764, 603 veterans with diabetes out of

3,843,832 unique veteran users, for a prevalence 

of 20%; this compares to 639, 323 (19% prevalence)

for FY 2000; 503, 321 (16% prevalence) for FY 1999,

and 420, 486 patients (14% prevalence) in FY 1998.

This cross-sectional calculation technique probably

yields an underestimate compared to the prevalence

calculated from a longitudinal analysis.

Based on registry data analysis for patients with A1c

performed in VHA laboratories, the mean HbA1c for

FY 2001 was 7.37 compared with 7.61 in FY 2000;

and the mean LDL was 104 mg/dl compared with 108

mg/dl in FY 2001.

Lower Extremity Amputation Programs (Offices of

Policy and Planning and Patient Care Services).

In collaboration with the Centers for Disease Control

and Prevention, Division of Diabetes Translation,

a 12-year Lower Extremity Amputation (LEA) Registry has been created by the Office of Policy and

Planning. From FY 1997-FY 2000, the age-adjusted

rate (standardized to the VHA 1998 User Population)

of LEA in the entire veteran population has decreased from 2.18 (0.78 major amputations [e.g., below

knee or above knee]) to 1.42 (0.65 major amputations)

per 1,000 VHA users in FY 2000. The VHA is in the

process of updating its data through 2002.

In FY 2001 the Under Secretary for Health reissued

the VA Preservation, Amputation Care and Treatment

Directive (PACT), which mandates multidisciplinary

foot care programs, including screening, surveillance, and salvage components, at all VHA facilities.
DMICC ANNUAL REPORT 62 FY 2002

VHA recently participated as a full partner with 

the American Diabetes Association, the Centers for

Medicare & Medicaid Services (CMS), the American

Podiatric Medical Association, and the Centers for

Disease Control and Prevention in an initiative to

improve foot care for Medicare beneficiaries with

diabetes. CMS’s comprehensive decision memorandum cites five VHA research papers as providing 

scientific evidence to support the requested 

coverage benefit.

Guideline Development (Offices of Quality and

Performance and Patient Care Services ). VHA, in

partnership with the Department of Defense, has

revised its February 2000 version of the Diabetes

Clinical Practice Guidelines. The guidelines, covering

outpatient management of glycemia, blood pressure,

hyperlipidemia, diabetic retinopathy, foot care, and

renal disease, emphasize transparency of the evidence underlying clinical recommendations as well

as principles of absolute risk reduction and patientclinician target (HbA1c) value negotiations.

Research Service. There are three VA Diabetes

Centers of Excellence focused on diabetes research

co-funded by Medical Research Service and the

Juvenile Diabetes Foundation International. Investigators at these sites are investigating the effects of

diabetes upon the vascular system; mechanisms of

insulin resistance; cellular and molecular processes

by which intensive therapy reduces insulin resistance; the role of exercise in modulating the effectiveness of therapy; and mechanisms responsible for

defective low blood sugar regulation.

VHA has funded a 5-year cooperative study (VA

Diabetes Trial (VADT), CSP #465) to evaluate the

effect of near-normal glycemic control upon cardiovascular outcomes in type 2 diabetes. The VADT will

enroll 1,700 men and women from 20 VHA sites randomized to intensive versus conventional control.

The outcome will be assessed by evaluating composite cardiovascular events. Recruitment is ongoing.

The VHA Quality Enhancement Research Initiative

(QUERI) has been cited as a model by the Institute 

of Medicine. The goals of QUERI initiatives are to

translate research into improvements in patient care

and outcomes. The primary focus of the Diabetes

Mellitus QUERI–DM program is upon more–aggressive treatment of modifiable risk factors and the prevention of progressive complications among veterans

with diabetes. These activities range from the implementation of interventions to assist “front-line” clinicians with targeting high-risk patients to the design

and evaluation of alternate methods for constructing

diabetes care quality indicators. QUERI–DM continues to work with partners outside VA, including the

Centers for Disease Control (Translating Research

Into Action for Diabetes). This project will produce 

a structural and organizational analysis of VHA 

diabetes care and allow direct comparisons with 

diabetes care in the private sector.

Joslin Vision Eye Network (Office of Patient Care

Services). The VHA is a participant in the Telemedicine Project for Non-Mydriatic Retinal Examination in partnership with the Joslin Vision

Network. The Joslin Vision Network is a congressionally mandated project, which currently includes

the VHA, the Department of Defense (DoD), and the

Indian Health Service. The project involves imaging

the retina with a non-mydriatic camera and transmitting the images to a reading center. A recent 

VHA teleopthamology (digital imaging) consensus

conference made recommendations on the technical

aspects of data acquisition. DoD, and the VHA is 

in the process of evaluating the operational issues

associated with the implementation of teleopthamology at the facility level.

Standardization of Glycated Hemoglobin Testing.

Consistent with a directive from the Under Secretary

for Health, all VHA facilities use methodology traceable to the Diabetes Control and Complications Trial

(DCCT) standard as recommended by the National

Glycosylated Hemoglobin Standardization Program

(NGSP). This has been acknowledged by the NGSP in

its publications and on its Web page.
DMICC ANNUAL REPORT 63 FY 2002

Education. Over 30 VHA facilities have obtained

American Diabetes Association Recognition of their

patient education programs—more than any other

national system of health care. VHA hosted the 4rd

annual National Diabetes Symposium for over 250

endocrinologists and primary care clinicians, as well

as the annual VA Diabetes Educators Conference 

for nearly 300 VHA clinician educators. These conferences represent an institutional commitment to

translating agency priorities and research findings

into results at the field level.

Future Activities

VHA remains committed to improving outcomes for

veterans with diabetes. A nationwide approach to

more aggressive blood pressure control, instituted

last year, remains a priority. Research Service funded

proposals for research to improve eye care and blood

pressure control. The Under Secretary for Health, in

the reissued PACT directive, has directed that senior

management review network amputation rates. A

national Web-based learning center is being pilot

tested. VHA has a national Computerized Patient

Record System (CPRS), with clinical reminders, and

improvements to CPRS to support all clinical care,

including diabetes, are ongoing. The VHA leadership

role in the use of medical informatics has been noted

by the Institute of Medicine.
THE NATIONAL DIABETES EDUCATION PROGRAM
DMICC ANNUAL REPORT 67 FY 2002

Fiscal Year 2002 Accomplishments

INTRODUCING THE NATIONAL DIABETES

EDUCATION PROGRAM

The National Diabetes Education Program (NDEP) 

is jointly sponsored by the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

and the Centers for Disease Control and Prevention

(CDC) and is a subcommittee of the Federal Government’s Diabetes Mellitus Interagency Coordinating

Committee (DMICC). The program speaks to a national audience of people with diabetes and their families, health care providers, payers and purchasers of

health care, health care system policymakers, and the

general public, including people with undiagnosed

diabetes and those at risk for the disease.

The NDEP’s efforts are aided by a Steering Committee

comprised of representatives from diabetes-related,

health care, racial/ethnic, and voluntary service

organizations. Federal liaisons to the NDEP Steering

Committee include several representatives from the

DMICC. Members of the Steering Committee also

serve on NDEP Work Groups that provide direction

and help implement NDEP initiatives.

The NDEP also has developed a Partnership 

Network of about 200 organizations to help disseminate program messages through the mass media,

community groups, and health systems serving 

people with diabetes. A new web site, called “Team

Diabetes,” has been launched to provide an interactive, online site for NDEP partners to exchange

resources and information.

In June 2001, the NDEP published Changing the 

Way Diabetes Is Treated, A Progress Report from the

National Diabetes Education Program that reviewed

the NDEP’s accomplishments since its inception in

1997 through Fiscal Year 2000. This booklet details

the origins, development, activities, and future priorities of NDEP and has been distributed widely in 

the diabetes community. To obtain copies of this publication, please contact Joanne Gallivan, Program

Director, NDEP, NIH at Joanne_Gallivan@nih.gov.

During FY 2002, NDEP supported a variety of activities to promote awareness about the importance of

comprehensive diabetes care and to add an important new message about diabetes prevention. Highlights of NDEP’s activities during the past year are

summarized below.

NDEP Steering Committee

The Steering Committee met twice—in October 2001

and June 2002 in Washington, D.C. The purpose of 

the meetings was to coordinate and advise on program policies, initiatives, and goals and to help coordinate efforts. The October meeting was planned to

outline the Program’s three-year strategic plan and 

in June, the meeting included a discussion of plans

to develop a diabetes prevention campaign, as well

as program evaluation efforts.

THE NATIONAL DIABETES EDUCATION PROGRAM
DMICC ANNUAL REPORT 68 FY 2002

Mass Media Campaigns

From June 1998, when NDEP launched its first Public

Service Announcement (PSA) campaign, through FY

2002, NDEP’s campaigns have obtained well over $13

million in free advertising time or print media space.

The NDEP continues to promote its comprehensive

care campaign and provided support for tailoring

this campaign targeted to several minority audiences. The program also began planning the launch

of its diabetes prevention campaign and initiatives.

NDEP carried out extensive market research prior to

initiating these campaigns and developed the materials in conjunction with appropriate NDEP Work

Groups. The program also provided ongoing support

for continuing campaigns targeted to African Americans, Hispanic/Latino Americans, American Indians,

and Asian Americans and Pacific Islanders.

“Be Smart About Your Heart: Control the ABCS of

Diabetes” creates awareness about the link between

diabetes and heart disease and promotes comprehensive diabetes care to control blood glucose (hemaglobin A1c), blood pressure, and cholesterol—the ABCs

of diabetes. In November 2001, the "Be Smart About

Your Heart" brochure was completed and printed.

A major promotion of the brochure was conducted 

in the media as part of National Diabetes Month.

In February 2002, in coordination with the American

Diabetes Association (ADA), U.S. Department of Health

and Human Services Secretary Tommy G. Thompson

announced the results of an ADA-commissioned survey showing the lack of awareness in people with

diabetes about the link between diabetes and cardiovascular disease. In June 2002, NDEP and ADA announced results of an ADA commissioned survey of

health care providers understanding and promotion

of the comprehensive care messages. “Be Smart”

messages and materials continue to be promoted 

by NDEP partners.

“Si Tiene Diabetes, Cuide su Corazón” is NDEP’s

campaign aimed at helping Hispanic Americans better understand the need to control all aspects of their

diabetes to help prevent heart disease. Hispanic and

Latino Americans with diabetes are at higher risk of

heart disease, but they can reduce that risk, according to a new bilingual brochure, “Usted es el corazón

de la familia...cuide su corazón” or “You are the heart

of your family...take care of it.” In July 2002, the campaign was announced at the National Council of La

Raza’s annual meeting.

“Move It!” is the call to action of the American

Indian Youth Campaign, which addresses the rising

prevalence of type 2 diabetes in American Indian

young people. The campaign includes a series of three

posters, a print ad, a fact sheet, and suggestions for

ways to increase physical activity at school. A “Move

It!” kit has been sent to the Bureau of Indian Affair’s

American Indian schools.

In May 2002, during Asian/Pacific Islander Heritage

month, the NDEP promoted a specially tailored

tracking card for comprehensive diabetes care for

this population.

Media Outreach

In conjunction with these PSA campaigns, NDEP 

continued to conduct media outreach to obtain coverage about diabetes in the print and broadcast media.

Program messages were featured in a number of national media outlets. In November 2001, a Video News

Release was distributed to over 150 stations in top

media markets that promoted the ABCs message and

availability of the ABCs brochure. BET.com featured

messages about the ABCs of diabetes and famous

African Americans with diabetes during Black History

month and Heart and Soul magazine featured an

article on this topic. As part of the partnership with

ADA, the “Be Smart” campaign has been covered in

Newsweek, Time and U.S. News & World Report.
DMICC ANNUAL REPORT 69 FY 2002

NDEP Conference Participation

Program spokespersons gave presentations and 

represented NDEP at several meetings in FY 2002.

Conferences included the American Dietetic Association’s annual meeting in October 2001; the American

Public Health Association meeting in November 2001;

the ADA Postgraduate Course in January 2002; the

American Association of Diabetes Educators annual

meeting in August; the CDC’s Diabetes Translation

Conference in May; the annual meeting of the ADA in

June; and the annual meeting of the National Council

of La Raza in July.

Diabetes at the Worksite

NDEP’s Business and Managed Care Work Group 

has designed a web-based resource that employers

and human resource and health professionals can

use to assess the scope of the diabetes problem in

their workforces and to conduct diabetes education

at the worksite. Hosted by the Washington Business

Group on Health, this resource was launched in April

2002 and is available at www.diabetesatwork.org.

Diabetes in Children and Adolescents

This Work Group has completed a set of resource

materials for health care professionals, parents,

and others concerned about diabetes in children and 

adolescents. Materials include fact sheets, an annotated bibliography, and a resource directory. The

Work Group is developing a series of tip sheets for

children with type 2 diabetes and their families. In

addition, a manual for school personnel on managing

children with diabetes at school is being finalized.

Health Care Professional Work Group Activities

NDEP’s Health Care Provider Work Group provided

guidance for the Comprehensive Care Campaign 

and continued to promote the “ABCs of Diabetes”

message. The group is developing a Web site that 

will promote various system changes and approaches

to improve the quality of diabetes care, including

clinical practice tools.

The Pharmacy, Podiatry, Optometry, and Dentistry

(PPOD) Work Group is developing a diabetes primer

to expand PPOD professionals’ understanding of

their role in care for people with diabetes beyond

their own specialty and to include education about

the need for glycemic, blood pressure, and cholesterol control for people with diabetes. The group 

also helped revise the publication “7 Principles for

Controlling Your Diabetes,” adding messages about

the ABCs of diabetes and caring for the feet, eyes,

and teeth and proper medication use for people 

with diabetes.

The Older Adults Work Group is developing materials

to promote the newest benefits for people with diabetes who are Medicare recipients, including Medical

Nutrition Therapy and diabetes self-management.

Future Activities

During Fiscal Year 2003, NDEP will not only continue

to promote comprehensive diabetes care but it also

will take the lead in translating and promoting the

findings of the recently completed Diabetes Prevention Program (DPP) clinical trial. The DPP demonstrated that the onset of diabetes could be prevented

or delayed among people at risk for the disease through modest lifestyle changes such as 150 minutes

of moderate activity per week and losing 5 to 7 percent of one’s body weight. This important prevention

message will add a new dimension to the NDEP and

its goal of “changing the way diabetes is treated.”

For more information about the National Diabetes

Education Program, please visit our web sites at

http://ndep.nih.gov and www.cdc.gov/team-ndep 

on the Internet.
MEETING SUMMARIES
DMICC ANNUAL REPORT 73 FY 2002

THE DIABETES PREVENTION PROGRAM (DPP)

AND TRANSLATION

March 11, 2002

National Institutes of Health

Bethesda, Maryland

WELCOME 

–Allen Spiegel

Dr. Spiegel opened the March 11, 2002, meeting of 

the DMICC for the purpose of discussing the critical

issue of translating the results of the Diabetes Prevention Program (DPP). He stated that data from the

Centers for Disease Control and Prevention (CDC)

shows that the incidence of type 2 diabetes is growing at an epidemic rate in the United States and

worldwide. Dr. Spiegel indicated that findings of the

DPP have received extensive coverage and interest

since Dr. David Nathan, DPP Study Group Chair, first

presented them to the DMICC on August 8, 2001.

Immediately after the August 8th DMICC meeting,

Secretary Tommy G. Thompson of the U.S. Department of Health and Human Services (DHHS) held 

a press conference to publicly announce the results

and declare his commitment to disseminating them.

The DPP primary results were published in the

February 7, 2002, issue of the New England Journal

of Medicine.

Dr. Spiegel reminded the group of the statement of

Dr. Claude Lenfant, Director of the National Heart,

Lung and Blood Institute, who said, “It’s great to

have a paper in the New England Journal [but] if it

sits on the shelf, we will have accomplished nothing.” Dr. Spiegel asked that the group address the

translation problem cohesively and that they apply

their scientific, critical thinking to recommend pragmatic, effective ways to move forward and translate

the reality of these prevention findings.

To prepare for developing a framework for action,

the group first heard from representatives of the

public sector. Dr. Nathan presented an overview of

the DPP trial and its results. The potential role of 

the National Diabetes Education Program (NDEP)

was given by Drs. Charles Clark and David Marrero.

Dr. Richard Kahn then discussed the American Diabetes Association’s concerns about the challenges 

of translating the results into effective action.

Ms. Kathy Berkowitz spoke of the interest of the

American Association of Diabetes Educators in DPP.

Mr. Ned Calogne discussed translation issues at 

the State level, and Dr. Joseph Selby described the

managed care perspective. The presentations are

summarized here. Copies of their slides can be 

found at http://www.niddk.nih.gov/federal/dmicc/

meetings.htm.

MEETING SUMMARIES
DMICC ANNUAL REPORT 74 FY 2002

PRESENTATIONS

DPP Primary Results – David Nathan

An overview of the DPP primary results presented 

by Dr. David Nathan demonstrated that type 2 

diabetes could be prevented or delayed in a group 

of participants at high risk for developing type 2 

diabetes by reason of their having impaired glucose

tolerance and that there are approximately 10 million

individuals in the United States at comparable high

risk. The DPP demonstrated that modest lifestyle

changes or the use of metformin can help stem the

growing diabetes epidemic of more than 800,000 new

cases of type 2 diabetes a year. Dr. Nathan emphasized that, although the U.S. population is projected

to increase only slightly, the risk of developing diabetes is projected to increase 100 percent over the

next 50 years. Thus, diabetes and its complications

will create an enormous health care and financial

burden for our Nation.

The DPP, along with Finnish and Chinese studies,

has shown that managing impaired glucose tolerance

(IGT) can slow or prevent progression to diabetes 

in those at high risk and even reverse the IGT. Since

most diabetics are not diagnosed until 4 to 7 years

after developing the disease, at which time early

complications such as cardiovascular disease have

already started, screening for IGT and intervening

early can produce significant human and financial

cost savings. Results are still being analyzed, but

early indications are that managing IGT also has

prevention benefits for cardiovascular events and

atherosclerosis.

The DPP selected participants from the upper half 

of a group considered to be at risk for developing

type 2 diabetes. Since people are not normally identified as having IGT, the DPP screened for patients who

were overweight and had a family history of diabetes. Eligible study candidates had both a 2-hour

oral glucose tolerance test (OGTT) glucose level of

140 to 199 mg/dL and a fasting glucose level of 95 to

125 mg/dL. Forty-five percent were from minority

groups and 20 percent were age 60 or older, both

groups who are disproportionately affected by diabetes. Eligible participants at the 27 clinical centers

were randomized to either intensive lifestyle; metformin, 850 mg BID; or to placebo.

Dr. Nathan made the distinction that the lifestyle

intervention was a supportive, comprehensive,

and intensive program with moderate exercise and

weight loss goals. The goal of the lifestyle intervention group was loss of 7 percent of body weight 

(10 to 15 pounds), restriction of daily dietary fat to 

25 percent and caloric intake to 1200-1800 calories,

and 150 minutes per week of physical activity, such

as brisk walking. Participation and retention were

both excellent. At the end of the study, 93 percent 

of participants completed the study and 93 percent

completed all study outcome visits. Dr. Nathan 

said that these retention and participation figures

reflect the motivation and dedication of the study

volunteers and the skill of the centers and the DPP

staff members.

Because of the strong positive results achieved by

May 2001 and the recommendations of the Study

Data Monitoring Board, the NIDDK ended the study

one year early. The study findings demonstrated that

lifestyle intervention reduced the risk of developing

diabetes by 58 percent and metformin reduced the

conversion to diabetes risk by 31 percent for an average of 2.8 years of exposure.
DMICC ANNUAL REPORT 75 FY 2002

Dr. Nathan said that to have a public health impact

the target at-risk audience must be identified and

their cooperation must be obtained in order for

translation of the study results to the at-risk population. Whether public health results similar to those

of the DPP can be obtained will depend a great 

deal on the public health message developed and

channels used for communication.

Dr. Nathan pointed out that important questions

need to be resolved about the cost-effectiveness 

of the DPP interventions, how the results will translate to the larger population group at high risk, and

how to accomplish the translation. The DPP Research

Group is conducting analyses and preparing for a 

5-year followup study with the cohort of DPP participants to determine the clinical consequences and

benefits of DPP interventions over time.

The National Diabetes Education Program Role in

DPP Translation – Charles Clark, David Marrero

Dr. Charles Clark and Dr. David Marrero reported 

on a proposed multi-faceted, three-phase NDEP 

campaign with specific target audiences, objectives,

messages, and plans of action. A tentative slogan 

for the diabetes prevention campaign is “Small Steps.

Big Rewards.” The program targets three separate

audiences—health care providers and allied professionals, people at risk for type 2 diabetes and other

stakeholders, and health care purchasers, payers,

and the media. With the help of CDC, NDEP will conduct focus groups with each audience to test and

refine the effectiveness of the campaign strategies

and messages.

Following an initial 3-month provider phase, the

campaign will target the at-risk population similar 

to the volunteers in the DPP. Diabetes tends to run in

families and disproportionately affects racial/ethnic

minority groups. The campaign will therefore target

the at-risk group’s family and friends, those who

have diabetes and their supporters, and the community at large. Dr. Marrero emphasized that communicating the DPP results requires less a medical model

as much as a community health model. Changing the

behavior of the ten million high-risk people similar

to those in the DPP is a community effort. The message will be that modest changes make a big difference. Individuals will be encouraged to see their 

doctors and be tested. Options will include lifestyle

modification—eat better and get moving—and/or

medication. Channels of communication will include

local and culture-based media outlets, food editors

and shows, celebrities, and community and faithbased groups. Messages will stress that diabetes 

prevention is not only for adults at risk; it applies 

to children and young people who are developing

patterns that lead to increased risk.

Drs. Clark and Marrero pointed out that NDEP began

with the goal of changing the treatment of diabetes

today and ultimately trying to prevent diabetes. The

“ultimately” came quicker than expected. Now the

goal is not only to change the way diabetes itself is

treated, but also the way pre-diabetes is treated as 

a health risk.
DMICC ANNUAL REPORT 76 FY 2002

American Diabetes Association (ADA) Perspective

– Richard Kahn

Dr. Richard Kahn, Chief Scientific and Medical

Officer, ADA, stated that ADA took the lead many

years ago to screen people for diabetes. Now, he

said, perhaps we are going to screen people for 

pre-diabetes. Dr. Kahn presented the following

issues that his organization considers crucial to 

creating a framework for action to translate the 

DPP results:

•Achieving results similar to the DPP will be difficult. There is no provision in today’s health care

systems to pay for the type and extent of the intervention done in the clinical trial. If we identify 

people and tell them they are at risk, then we must

offer them specific, focused, doable interventions.

This must be more than “lose weight and exercise.”

This public awareness message has been around

for a decade and has not been very successful. We

need a lifestyle intervention similar to DPP that is

less expensive than DPP’s. Or are there other, more

cost-effective strategies that would produce the

same results? Can the results be maintained?

•The means for identifying the target audience must

be decided. Will the OGTT or fasting glucose test

(FGT) be used? They are not interchangeable. What

happens when the scientific community changes

the values defining pre-diabetes and diabetes? Or is

there another algorithm that can be used for which

a scientific basis does not yet exist.

•The term for the condition that defines the at-risk

population must be carefully selected. Is IGT or

IFG, whichever is chosen, a pre-disease condition 

or a disease? Is it early stage diabetes or prediabetes? There are very few diseases we treat,

and receive reimbursement for treating, in the predisease stage. What do we tell people they have?

Deciding what to call the state is important for 

the message, the testing, the reimbursement, and

the intervention.

It was also announced that ADA and NIDDK will

publish a position statement on diabetes prevention

in the April 2002 edition of Diabetes Care. (Diabetes

Care, Vol. 25: 742, 2002).

American Association of Diabetes Educators

(AADE) – Kathy Berkowitz

Ms. Kathy Berkowitz, President, AADE, assured

DMICC that her group of some 10,000 nurses,

dieticians, pharmacists, and other health care disciplines are experienced, qualified, and committed 

to a team approach to translate the DPP results. Most

of AADE’s members have been involved with diabetes

for 10 or more years. Currently the country’s 12,000

Certified Diabetes Educators must serve some 16 

million persons with diabetes. To assist in the translation effort, many more educators will be needed 

to reach the 10 to 20 million persons at risk.

AADE expects the DPP to widen the scope of the 

diabetes educator’s role, increase the demand for

services, and enhance the value of the diabetes educator. AADE is in the process of developing a position

statement on diabetes prevention and the impact 

of DPP on the diabetes educator’s role. AADE has

planned a multi-organizational Lay Health Worker

Summit for April to reach community health workers.

This effort is designed to identify those who are

already delivering some diabetes education and

reach consensus on a role for them in reaching more

people with diabetes and those at risk for diabetes.

DPP will be a prominent subject at their August 2002

annual meeting. The association will include some

form of prevention education and the interventions

in their practice standards, such as distributing 

the “Am I at Risk” pamphlet. They are planning to

develop web-based, continuing education programs

and articles in their publications.

Ms. Berkowitz noted that AADE will be developing

both patient education materials and professional’s

toolkits to help their members understand, apply,

and disseminate the DPP information. They also will

be working with CDC’s training program for community health workers.
DMICC ANNUAL REPORT 77 FY 2002

Translation at the State Level – Ned Calogne

Dr. Ned Calogne, prior to becoming Chief Medical

Officer and State Epidemiologist for the Colorado

Department of Public Health and Environment,

was Chief of Preventive Medicine for Kaiser Permanente and worked closely with the DPP principal

investigator at the Denver center. Dr. Calogne pointed

out that States do not receive much State funding 

for public health efforts. Funding for much of what

they do comes from other sources, such as Federal

grants from CDC, prevention block grants, tobacco

settlements, local and national foundation grants,

and non-public health community partners. State

funds only allow for limited training, production of

materials, and information dissemination. Another

challenge to any role for States in translating DPP

research is that most public health takes place at the

local level. Matching State needs with Federal goals

can be difficult, but trying to match local needs and

State goals is often more difficult. Translating programs down into local health departments—which

have their own issues, their own strategies for funding, their own county commissioners, their own local

politics—is a huge issue.

Dr. Calogne identified three areas for translation 

of the DPP findings: (1) screening and definition 

of the glycemia problem; (2) behavior change; and 

(3) chemoprophylaxis.

There are no public health funds currently available

for screening for impaired glucose tolerance. The

State would need to influence supportive policies 

for screening through its community partners, including health systems, insurers, community health

services, Medicare, and Medicaid. To translate DPP,

Dr. Calogne said States would need assistance and

cooperative efforts from DMICC member agencies.

Funding through grants and cooperative agreements

is a familiar and comfortable mechanism for States.

Integration with existing programs, such as the 

cardiovascular, diabetes, and weight management

programs, would ease the oversight and 

administrative burden.

Dr. Calogne described several things that have

worked in public health. One was the use of 

tobacco money to fund a quit-line and the collaboration with Kaiser Permanente to provide smoking 

cessation pharmaceutical aids to quit-line participants. Although the effectiveness of the intervention

is still unknown, it is an example of a collaborative

effort to create awareness and facilitate an intervention. Use of the Internet as active deliverer of an

intervention might be a low-cost possibility that

could be applied on a broad basis.

Dr. Calogne asked rhetorically what the role of the

public health service should be? Should it be primarily to raise awareness? Or to provide direct care?

Managed Care Perspective – Joseph Selby

Dr. Joseph Selby, Director of the Division of Research,

Kaiser Permanente, is overseeing the TRIAD study 

in diabetes management in a managed care setting.

Although he was speaking about Kaiser’s reactions 

to DPP, he pointed out that other organizations were

also very interested in DPP. One is the American

Association of Health Plans (AAHP), the national

organization representing the vast majority of health

plans in D.C. AAHP coordinates a CDC-funded research program and sponsors a number of chronic

illness initiatives relevant to translating the DPP.

Working with NIH, it is actively engaged in promoting clinical trial participation for HMO-enrolled

members in its health plans. Another organization 

is the HMO Research Network, a 6-year-old research

center association of 14 large health plans covering

20 to 30 million people. Currently, the HMO Research

Network is receiving more than $30 million in NIH,

CDC, and Agency for Healthcare Research and

Quality (AHRQ) research funds. This is an active,

population-based research effort and group that 

will very likely participate in translation of the DPP.
DMICC ANNUAL REPORT 78 FY 2002

Kaiser Permanente’s Care Management Institute

(CMI) responded very quickly to announcement of 

the DPP results. CMI was already working in the

areas of overweight and diabetes. The Institute supports the development of evidenced-based population

disease management across the nine separately

incorporated regions of the Kaiser Permanente program. Nationally, Kaiser has 8.2 million members,

90,000 employees, and 11,000 physicians. CMI identifies affected populations; identifies and disseminates

best practices; supports clinicians and specialized

staff; provides feedback; and measures, reports,

demonstrates, and, hopefully, improves outcomes.

Dr. Selby stated that diabetes is the paradigmatic

chronic illness, the classic disease management 

disease, the care for which must be solved and resolved if we are ever to manage health care costs.

Kaiser has been aware of the tremendous impact of

diabetes on its membership for years. In 1994, Kaiser

was spending $3,300 additional dollars per member

per year on care for its diabetic members in the

Northern California region alone. About half of this

was spent on acute and chronic complications. In

monitoring the incidence of chronic illnesses, using

the same criteria from 1996 to 2000, Kaiser has found

no change in the prevalence of congestive heart failure, no change in the prevalence of coronary artery

disease, but a 33 percent increase in the prevalence

of diabetes over just the past 5 years.

Shortly after the August press release on DPP,

CMI convened a meeting in Portland of clinicians,

other providers, and health educators interested in

obesity and diabetes. They developed short- and

long-term themes on strategies for preventing obesity including (1) development of partnerships with

schools, employers, government agencies, and academic researchers; (2) establishing collaborations

with other health plans on coverage and incentive

issues, such as employer-based incentive programs

around weight management; and (3) establishing a

national advisory group on overweight and obesity.

The Kaiser Permanente Clinical Network managed

and supported by CMI will risk-stratify the overweight population, including the subgroups with

decreased HDL, hypertension, IGT, and gestational

diabetes, to direct intensive efforts toward those 

at high risk. Dr. Selby said it is doubtful that Kaiser

Permanente will push now to identify the IGT 

population per se.

Kaiser’s strategies for ongoing improvement include

the clinical network to rapidly disseminate new 

findings as they are published or as Kaiser becomes

aware of them. CMI intends to see research conducted on translation within its membership and its

research centers funded by internal Requests for

Applications (RFAs). Kaiser also hopes to partner

with Federal and State-level demonstration projects.

Presentation of Risk Assessment Concept

Discussions during the morning presentations 

centered on which risk assessment measurement

should be used (IGT or IFG), which test should be

used (OGTT or FGT ), or whether there is another

profile or test that could be used for risk assessment.

It was suggested that a possible risk assessment

model based on BMI and other factors might provide

enough of a profile to justify lifestyle intervention 

for a subset of the population and further screening

for another subset thought to be at higher risk.

Before the group recessed for lunch, Dr. Allen Spiegel

offered the following risk assessment concept that

could be used for the afternoon discussions. He suggested that this tool could be Internet-based.
DMICC ANNUAL REPORT 79 FY 2002

A potential at-risk group would be identified based

on a weight and family history profile. The total

group would then be stratified into low, middle,

and high subgroups according to each person’s risk

assessment profile. Parameters would need to be

defined for this stratification, and guidelines would

be needed for each subgroup. For those placed in the

low-risk subgroup, the guideline might be that there

is no problem. For the middle subgroup, although it

is arguable, some form of lifestyle counseling might

be needed, such as the doctor simply advising them

to lose weight and exercise. These persons would 

not be tested or receive medication.

In Dr. Spiegel’s concept, persons in the high-risk 

subgroup would be screened for glucose tolerance.

If the test indicated the person was in the normal

range, then a retest would be done at some interval

(e.g., 3 years). If the test showed the person was diabetic, then treatment would be necessary. If the test

indicated the person was pre-diabetic according to

the criteria established, then intervention would be

required, either lifestyle or medication.

The ADA/NIDDK position statement on the result 

of recent prevention studies including the DPP recommends lifestyle intervention be tried first. What

the lifestyle intervention would be and how it would

be provided would have to be determined. There is 

a continuum in glucose intolerance to a point where

diabetes is present. There may also be a continuum

where exercise and diet are no longer effective

enough to prevent diabetes without the assistance 

of medication.

DMICC Agency Actions and Perspectives

The plans and viewpoints of several of the DMICC

agencies were presented by their representatives: Dr.

Judith Fradkin, NIDDK; Dr. Daniel Stryer, Agency for

Healthcare Research and Quality (AHRQ); Dr. Steve

Phurrough, Centers for Medicare & Medicaid Services

(CMS, formerly HCFA); Dr. David Stevens, Health

Resources and Services Administration (HRSA); Dr.

Kelly Acton, Indian Health Service (IHS); Dr. Leonard

Pogach, U.S. Department of Veterans Affairs (VA); 

Dr. Frank Vinicor, CDC; and Dr. Jean Flagg-Newton,

National Center for Minority Health and Health

Disparities (NCMHD). The panel’s presentations are

summarized here.

NIDDK

Dr. Judith Fradkin, Director, Division of Diabetes,

Endocrinology ,and Metabolism, NIDDK, stated that

NIDDK is working with the ADA, CDC, and NDEP to

translate the DPP results. There also are opportunities for collaboration among the DMICC members.

One major NIDDK focus of translational research 

is R18s for demonstration-and evaluation-projects.

These programs test clinical trial results with 

specific populations in the community setting.

The current R18 program announcement is focused

on developing cost-effective strategies for improving

treatment of patients with diabetes. NIDDK plans to

reissue that R18 with several other components of

the NIH and CDC and ADA. The re-issued version will

continue the focus on improving care for people with

diabetes, but it will now stress many of the research

goals identified in the ADA/NIDDK position paper

appearing in the April issue of Diabetes Care. The

program announcement will incorporate many of the

issues discussed at this meeting. Applications will be

accepted three times a year following the standard

R01 receipt date schedule. A special study section

will be convened by the NIDDK review branch and

meet three times annually.
DMICC ANNUAL REPORT 80 FY 2002

Another NIDDK new initiative focuses on prevention

of type 2 diabetes in children. NIDDK has been working with CDC to define the extent of impaired glucose

tolerance and of type 2 diabetes in children. Given

the anecdotal evidence and now the DPP sciencebased evidence for adults, the Institute felt it important to investigate methods for prevention of type 2

in children. Rather than the medical model used in

DPP, this will be a public health-focused initiative.

It will target school-based interventions that stress

increased physical activity and dietary education.

The outcome to be measured will be some form of

metabolic outcome, such as reaching a glycemic

threshold, rather than actual development of diabetes. Sites have been selected, and the first steering

committee meeting has been held.

A third effort is benchmarking what we are achieving

in translation through CDC’s NHANES, the mechanism by which we know what is happening in the

Nation and how well we are succeeding or failing in

terms of reducing risk or treating persons with diabetes. NIDDK has long provided data collection 

support of NHANES. Following NHANES III, NIDDK

stopped supporting glucose tolerance tests and supported fasting blood glucose measures, based on

ADA’s changed recommendations for diagnosis. Now

NIDDK would like to hear from the community if that

decision should be reviewed and oral glucose tolerance tests now be used for NHANES to monitor the

prevalence of impaired glucose functioning.

AHRQ

Dr. Daniel Stryer, Medical Officer and Internist,

Center for Outcomes and Effectiveness Research,

Agency for Healthcare Research and Quality,

explained that AHRQ is the Federal Government’s

organizational home for research on the delivery of

health care. Quoting Andrew Balas, a researcher at

the University of Missouri, Dr. Stryer said, “It takes

17 years to turn 14 percent of original research 

to the benefit of patient care.” Dr. Stryer listed the 

following DPP-related activities as part of AHRQ’s 

discretionary programs:

• The U.S. Preventive Services Task Force, an independent panel of experts that reviews the evidence

of effectiveness and develops recommendations 

for preventive practices, reviewed the DPP and 

recommended diet and exercise changes, but 

not screening.

• AHRQ’s Put Prevention Into Practice (PPIP) develops tools and resources for clinicians, office staff,

and patients. They will be creating diet and exercise materials to incorporate the DPP message.

• The Office of Health Care Information will add DPP

to its present prevention activities portfolio.

Dr. Stryer also mentioned his agency would welcome

any submissions to a new RFA being issued in partnership with the VA for AHRQ’s Translating Research

Into Practice (TRIP) portfolio. Another TRIP RFA in

partnership with HRSA will be coming out shortly to

assess the Disparities Collaboratives, of which diabetes has been one, to find ways to improve their

effectiveness and efficiency. There are also plans for 

a collaborative focused on diabetes prevention.

Information gained from the work of AHRQ’s Excellence Centers to Eliminate Ethnic/Racial Disparities

(EXCEED) should help implement the DPP message.

Nine centers across the country are focused on

understanding why disparities exist and identifying

strategies to reduce or eliminate them. The University

of Colorado center is looking at Native American

health. Other programs are focused on risk communication and cultural competence. Other AHRQ community-based participatory research activities should

also help in DPP translation by building on the

strengths of these groups.

In closing, Dr. Stryer told the group of the sad 

loss the previous day of AHRQ’s Director, Dr. John

Eisenberg, with whom many of those present had

worked over the years.
DMICC ANNUAL REPORT 81 FY 2002

HRSA

Dr. David Stevens, Director of the Clinical Management and Professional Development Branch, Health

Resources and Services Administration, presented a

brochure and video, “Changing Practice, Changing

Lives,” to each DMICC member. Dr. Stevens stressed

that HRSA realized that to get better results in diabetes, major system changes were needed. HRSA 

provides approximately 26 percent of the funding 

for community-controlled health centers offering

comprehensive primary care to underserved, highrisk populations. Eighty percent are low income,

more than 66 percent are below the Federal poverty

level, and 40 percent are uninsured. A major goal 

is to reduce health disparities.

HRSA has identified four main areas in changing

clinical care practices that Dr. Stevens stressed were

very important. First is leadership; second is a documented model of care and a model for improvement

and learning. Third is infrastructure, and fourth is

strategic partnerships.

After the report of the DPP results, HRSA and CDC

thought this provided a great opportunity for their

health centers. They plan to set up an expert panel to

develop concepts and evaluation measures for translating DPP recommendations into preventive care for

the underserved, based on their diabetes primary

care model. The centers’ program will include weight

reduction, exercise, and/or metformin. HRSA hopes to

have a pilot established by the third quarter of 2002.

The 9- to 12-month pilot will target their enrolled

patients and other persons in their communities.

With their current resources plus other resources

from CDC and a partnership with AHRQ, HRSA plans

to integrate the DPP initiatives into a prevention 

collaborative currently being designed. If additional

resources become available, they will develop a freestanding DPP prevention group, taking into account

the complexities inherent in this effort. Either

model—stand-alone or integrated—will be started 

by the latter part of 2002.

CMS

Dr. Steve Phurrough, Director of the Division of

Medical and Surgical Services, Coverage and Analysis

Group, Centers for Medicare and Medicaid Services,

explained that one of his group’s responsibilities is

to recommend items for CMS coverage to the Secretary of DHHS. Diabetes issues have been prominent

in their discussions the past couple of years and several new benefits have been added. When it comes to

DPP translation, Dr. Phurrough had to say that there

was not much CMS planned to do on this front. CMS

buys health care for its 39 million beneficiaries, 34

million of whom are over age 65, based on what

Congress tells CMS to purchase. Congress’s specific

requirements and specific limitations are basically

limited to what is reasonable and necessary for the

diagnosis and treatment of disease. Unless Congress

directs CMS to provide a benefit over and above diagnosis and treatment of disease, it is not covered.

Prevention, including screening, is a large category

that generally is not paid for.

Currently DPP screening and interventions do not 

fit into a CMS benefit category. There does exist the

potential for defining the risk state as a disease. Also,

DPP may not be primary prevention, but rather secondary prevention for obesity, which is not currently

a CMS disease. Secretary Thompson and former

Surgeon General Dr. David Satcher rather took issue

with that this past year, and there is discussion now

at CMS on whether obesity is a disease. If obesity

becomes defined as a disease, then there will be a

whole host of new coverage decisions to define treatment and diagnoses associated with obesity. If this

should happen, then treatment may fall in line with

what DPP is recommending. The problem, obviously,

in defining obesity as a disease is that the treatment

of obesity in the Medicare population would cut

physicians’ income by 20 to 25 percent across the

board to cover all the treatments that fall into the

realm of treating obesity. Therefore, it is unlikely 

this will happen in the near future.
DMICC ANNUAL REPORT 82 FY 2002

IHS

Dr. Kelly Acton, Director of the Indian Health Service

National Diabetes Program, stated that IHS has a

unique government-to-government relationship with

American Indian and Alaska Native (AI/AN) Tribes.

This puts constraints on the way IHS may do business with people. They may not dictate what will be

done. The Tribes have considerable input about and

control over their own health care.

As a federally funded primary health care agency,

IHS takes both a public health and a clinical approach to diabetes. The program’s basic components

are conducting surveillance, describing the problem,

providing standards of care and clinical guidelines

generated from the bottom up, developing publications, and reviewing the science. A yearly diabetes

care and outcomes audit looks at both process and

outcomes measures around diabetes. A new activity

has been the addition of 318 new diabetes grant 

programs under a special $100 million diabetes program funded through 2003 for American Indians.

Since IHS is not a grant-issuing agency, monitoring

318 new grants has been a real adventure. The program priorities are set by local tribal communities.

The director decided this was not going to be a topdown activity. Most communities are doing combinations of different preventions and two-thirds of the

programs are doing primary prevention activities.

Their efforts may have something significant to tell

us about translating DPP activities at the local level.

Dr. Acton provided evidence that incidence and mortality from diabetes significantly disproportionately

affect American Indians. Also rates in cardiovascular

disease (CVD), for which diabetes is a risk factor, are

decreasing in the overall U.S. population, but increasing in the AI/AN population. Fifty-six percent of 

cardiac events in American Indian men are in people

with diabetes, and their relative risk of CVD mortality is 2.9. Seventy-eight percent of cardiac events in 

AI women occur in those with diabetes, and their 

relative risk of mortality is 3.8.

Other data provided by an epidemiologist from CDC

shows that from 1990-98, there was a 6 percent

increase in prevalence rates for diabetes in children

under 15-years-old, a 68 percent increase in the 

15-19 year-old group, a 47 percent increase in 20-

24 year-olds, and a 50 percent increase in 25-34

year olds. IHS is deeply concerned about this trend 

in AI/AN youth. The National Diabetes Education

Program, American Indian Subgroup, is working 

with focus groups to ask the youth how to get a 

message across to them, and they have provided

some very insightful comments.

Dr. Acton researched the cost of care for diabetics

and found that a few years ago managed care estimated the cost of treating diabetes was about $5,000

to $9,000 per person, per year. It has probably gone

up. IHS currently cares for about 90,000 people with

diagnosed diabetes, so a conservative estimate is that

it should cost the Federal Government about $450

million a year. Unfortunately, the agency receives

only $1,578 per person, per year, so there are significant economic disparities in terms of the ability to

provide adequate diabetes care.

Since IHS and its providers already have difficulty

handling the current volume of patients with diagnosed diabetes, they are concerned about how they

can translate the DPP results. As an underfunded

agency working with a unique, primarily rural, population, IHS must be creative to translate the DPP

results into something meaningful. The agency would

like to enhance the current lifestyle programs in prevention. Could the non-clinical part of DPP be done

by trained community mentors or lay persons? They

are also talking about how to adjust their pharmacy

budgets to buy metformin when the budgets cannot

afford other drug therapies at this time.
DMICC ANNUAL REPORT 83 FY 2002

Dr. Acton said the agency’s short-term plans for 

DPP translation included a press release sent to the

Indian press and published around the country in 

all the Indian newspapers. DPP will be featured at

the National Tribal Leaders Diabetes Conference in

Denver in December 2002. Focus groups have been

held at four sites and interviews been done with

American Indian participants of the DPP. A special

edition of Health for Native Life focuses on DPP and

features DPP celebrities within American Indian

communities. These celebrities tell how they accomplished the interventions to inspire people and give 

a positive message about what DPP could mean to

the individual in American Indian communities.

IHS long-term plans include participating in discussions like those at the DMICC meeting to define

screening criteria and resolve other issues. The

agency wants to use experience being gained from

the grant programs and other programs to develop

lifestyle activities specific to AI/AN communities,

based on best practices or promising practices. They

will also be working to expand the funding base to

be able to purchase pharmacy supplies and equipment, fitness equipment, and so forth.

Dr. Acton said that, personally, she feels DPP means

HOPE to AI/AN communities. There is so much fatalism in the communities about diabetes. “You are just

going to get it. There’s nothing you can do.” Hopefully, DPP can change this mindset by projecting a

positive message. It can say, “This is not the same 

old story because now we have proof that diet and

exercise work.”

In the discussions on translating the research, Dr.

Acton emphasized that since diabetes tends to occur

within families, a method that has worked in the

AI/AN communities to change behavior has been to

relate it to preventing diabetes and its complications

in the children.

VA

Dr. Leonard Pogach, National Program Director 

for Diabetes, U.S. Department of Veterans Affairs,

presented the perspective of the Nation’s largest integrated health care system. Its Chief Medical Officer

is the Undersecretary for Health, who reports to the

DHHS Secretary. The VA treated 3.3 million veterans

in Fiscal Year 2000. The number is closer to 4 million

now, approximately 15 percent of the Nation’s veterans. The median age of a U.S. veteran is about 59.

Thirty-eight percent were over 65 in 2000, which is a

larger percentage than in the general U.S. population.

Women and African-Americans tend to be younger

than the white, male population, probably reflecting

changes in the military over the past several decades.

The health care agency uses an enrollment system

with a global budget and the effect of a capitation

system. In a sense, it is a giant staff model HMO for

patients who are largely, but not completely, economically challenged. Their indigent population, many 

of whom are minorities, is larger than that of most

other health care systems.

As a corollary to DPP, Dr. Pogach cited the 4S Study

reported by Hafner and Herman in 1999. In a subgroup of persons with impaired fasting glucose, simvastatin significantly reduced the number of major

coronary events, revascularizations, and total and

coronary mortality. The significance is the relationship of IFG and cardiovascular disease, which 

is the major cause of morbidity and mortality in 

diabetes. Dr. Pogach added that the efficacy of

aggressive blood pressure and cholesterol control 

in preventing morbidity and mortality in an IFG 

population also needs further study.
DMICC ANNUAL REPORT 84 FY 2002

According to Dr. Pogach, there are several unresolved

issues for the VA in translating the DPP results to its

patients. The VA is dealing with an older population,

with persons who have a number of disabilities that

might interfere with lifestyle interventions, and with

persons who are sick to begin with. The agency provides health care for about 750,000 people with diabetes. Some 1.2 or 1.5 million people with diabetes

receive care in the combined. U.S. Department of

Defense/VA care systems. Dr. Pogach estimated that

there are roughly 1.8 million veterans who are not

being treated for diabetes.

The agency is considering opportunistic screening

for impaired fasting glucose in veterans with other

DPP risk factors, but is not prepared to use the 

OGTT yet. VA expects to find that a lot of their

patients will have the DPP risk factors. Fortunately,

VA already provides access to dietary and lifestyle

education. They also distribute and share NDEP

materials. A prime issue is how to apply the DPP

intervention, which was rather intensive, to the VA

patient population. Use of metformin will be a fairly

convenient option. However, for those over 60 and

with lower BMIs, this was not shown to be a very

effective intervention. Dr. Pogach felt that it was very

important to vigorously identify and treat hyperlipidemia and hypertension in this same population.

To assist with DPP translation, VA has an active

health services research and development program.

Dr. Pogach indicated that for an issue of this magnitude, it probably would be possible to get servicedirected research to study it. Investigators can 

obviously put in for individual grants at any time.

Another asset the VA can offer is in terms of its

established performance measurement system and

computerized electronic medical records. They have 

a metric to identify individuals who should be targeted for screening and how they should be targeted.

Based on their experience, they can quickly and 

cost-effectively develop and validate a performance

measurement and collect data on how well a care

mechanism is performing. Their electronic medical

records system has computerized reminders that can

embed health factors, such as medical risk factors or

conditions that do not have codes, and then extract

that data from the system. This capability is something that the VA could provide in collaboration with

its Federal partners.

CDC

Dr. Frank Vinicor, Director of Diabetes Translation,

Centers for Disease Control and Prevention, spoke of

primary prevention from a public health standpoint.

Specific CDC prevention activities for 2002 include:

• Developing population-based methods for identifying persons at very high risk.

• Conducting formative research through focus

groups on views of primary prevention in collaboration with NDEP.

• Supporting demonstration projects with the CDCfunded Diabetes Control Programs and Community

Health Centers.

• Serving as purchaser/insurer of a possible 

TRIAD pilot project exploring managed care 

and primary prevention.

• Establishing an international work group with the

Finnish group on primary prevention in diabetes.

• Collaborating with NIH programs such as the 

DPP extension and “Environmental Approaches 

to Obesity.”

• Expanding economic studies of primary prevention, such as the cost implications of possibly

screening for unrecognized diabetes and IFG 

and IGT.
DMICC ANNUAL REPORT 85 FY 2002

Dr. Vinicor was emphatic in expressing his CDC division’s role as a leader in the public health community in diabetes. He insisted that the group must stick

with the DPP science and what works. The impact

that the power of science from DCCT and UKPDS had

on policymakers should not be underestimated. An

important issue is what investment in diabetes prevention are people, who do not see themselves as

direct stakeholders, going to be willing to make. Also,

what investment are providers willing to make?

There is a very large population at risk and there is

not a huge amount of money in any group to translate the DPP findings. Increasing the caseload from

16 million persons with diabetes to 10 or 20 million

at risk will be a challenge. If one case manager in 

the DPP took care of 20 or 25 people, and if the lifestyle intervention could be modified so that one case

manager could take care of 100 people, 50,000 case

managers would be needed to handle the minimum

10 million people with impaired glucose tolerance.

The country does not have 50,000 additional case

managers. There certainly are not the resources 

to take on 200 million people in this country. Like 

the bank robber Willie Sutton and the researcher

Doctor Baruch Blumberg, going to where the money

is, where the action is, and where the most likely

effect can take place is the thing to do.

Another reason for targeting a DPP-type population

is that there is not science to support that these

interventions are “good for everyone,” that they will

prevent a whole array of diseases. Dr. Vinicor cited 

a study done in England in which ethicists looked at

the quality of the evidence needed to make a difference for persons on a spectrum from terminal to

healthy. A quality value of only 20 was satisfactory 

to the terminally ill but a value of 80 was needed for

those at risk to pay attention and 90 was required 

by the healthy person. This again demonstrates the

importance of the DPP science and the importance 

of applying it accurately.

Dr. Vinicor stressed it is essential to focus on what is

known and what works and build on that beginning.

What works best in public health efforts is using

multi-faceted approaches. He said being an active

partner with others in cardiovascular disease and

obesity is okay, but that is not the primary role of

those whose assigned area of public health responsibility is diabetes. Their role is to focus on and lead

the DPP translation effort to prevent diabetes.

Finally, Dr. Vinicor said, “We need to go slowly and

move fast.”

NCMHD

Dr. Jean Flagg-Newton, Deputy Director of the National Center on Minority Health and Health Disparities, said that NCMHD’s vision is that there will be

an America in which all populations will have an

equal opportunity for long, healthy, and productive

lives. In its first year, the Center has spent considerable time focusing on congressionally mandated 

programs, completing the development of the transNIH strategic plan on research to address and eliminate health disparities, and working to establish its

Centers of Excellence networks across the country.

The law that established the Center was very specific

in terms of the activities that NCMHD would carry

out. There is a two-fold focus. First, the group is to

continue the collaborations that the previous Office

of Research on Minority Health had established.

Those collaborations are primarily with the other

NIH institutes and centers (ICs). There are also partnerships with AHRQ for their EXCEED Program and

the CDC Reach 2010 Programs. Secondly, NCMHD 

has a mandate to develop independent programs

focused on research, particularly in the areas of 

biomedical research, biobehavioral research, and 

the social sciences.
DMICC ANNUAL REPORT 86 FY 2002

NCMHD was a partner with NIDDK in support of the

DPP Program, as well as other programs related to

diabetes in terms of research and capability building. It is now the Center’s policy that the trans-NIH

Strategic Plan on Health Disparities will guide its

collaborations with the other NIH ICs. NIDDK’s portion includes the DPP followup and another major

initiative with a focus on racial and ethnic disparities in the incidence of diabetes and its complications. Dr. Flagg-Newton confirmed that NCHMD will

certainly be working with NIDDK in these areas.

NCHMD is also looking at what research needs to 

be initiated that is not now being done. Dr. FlaggNewton promised that they will be looking at those

areas in terms of future translation efforts. One 

of the areas that NCHMD might support would be

research in why sustainability is a problem.

In summary, Dr. Flagg-Newton encouraged everyone

to evaluate the proposed strategies for translation

and guard against thinking that a one-size-fits-all

translation program will yield equally successful

results across all racial and ethnic groups.

Discussion Summary

Questions and lively discussions on the issues 

and challenges of translating the DPP findings took

place after each of the presentations. The comments

and recommendations centered on the following

questions:

• What should the risk be named?

• Who is the target audience?

• How should the at-risk group be identified?

• How should the at-risk person be treated?

• What translation strategies are most effective?

• What are the challenges?

What Should the Risk Be Named?

Selecting the correct name for the risk that was

responsive to the DPP interventions was thought to

be crucial for implementing the DPP science, for

reimbursement, and for the impact of the message

on providers, persons at risk, payers, and policymakers. Of the many terms suggested (pre-diabetes,

impaired glucose tolerance, hyperglycemia, homeostatis dysregulation), pre-diabetes seemed to provide

the most promise. “Treating pre-diabetes” was

deemed more apt to be taken seriously than “preventing diabetes.”

Who Is the Target Audience?

Focusing on a high-risk population similar to that 

of the DPP trial was thought to have the greatest

potential for success in translating the DPP results.

Although “eat right and exercise” is good common

sense and a message Americans have been hearing

from many quarters in the past decade, it was felt

that to make the DPP translation a general population appeal would dilute its impact and effectiveness. First, the current messages about behavior

modification have been disappointingly ineffective.

Second, the DPP results occurred with a selected

high-risk group of persons who were overweight,

had impaired glucose metabolism, and a family history of diabetes. Targeting a similar group from the

10 to 20 million at-risk persons will be more effective than targeting the entire U.S. population or even 

only those who are overweight. Other target groups

should be health care providers, friends and families

of this high-risk group, especially racial and ethnic

minorities, and persons with diabetes and their 

supporters. Primary targets to assist in delivering

the message would be the media, community-and

faith-based groups, local and State governments,

and employers.
DMICC ANNUAL REPORT 87 FY 2002

How Should the At-Risk Group Be Identified?

The discussion centered on the risk assessment concepts presented before the lunch break by Dr. Spiegel

and described above. For those persons considered 

at high risk, there is the issue as to whether they

should be screened for glucose tolerance levels, and,

if so, which test should be used. The OGTT tends to

be the more reliable for identifying those with diabetes. On the other hand, an overnight fasting glucose test, currently being used under ADA guidelines

for identifying diabetes, is less expensive. Other

questions included: What parameters should be set

for each of the tests? What will happen if the values

identifying pre-diabetes change as they have done for

both diabetes and hypertension? Is there a different

test that could be used? Another issue was that it is

unlikely that either test would be reimbursable for

an at-risk rather than disease condition.

Some concern was expressed about categorizing the

at-risk population. One problem in presenting people

with categories is the tendency to think, “Well, I’m in

the lower end, so that’s okay for now” or “I’m a little

bit in the upper part, but I’m on the lower end of the

upper part.” In other words, people tend to think “I’m

sick or I’m healthy.”

How Should the At-Risk Person Be Treated? 

If the person is in the IGT- or IFG-positive group, by

whatever test, then he or she already has increased

cardiovascular disease risk and increased risk of

developing frank diabetes, but it is not inevitable.

The group felt that the cholesterol paradigm was

very relevant. The significance at this point is that

type 2 diabetes is very difficult to treat and may,

at some stage, be irreversible because of beta cell

failure.

In DPP, the lifestyle modification was generally the

better intervention in all groups, but it was emphasized that medication as an intervention should not

be dismissed. Both the DPP younger group and those

who were more obese responded equally well to metformin and lifestyle intervention. It is also important

to consider people’s biases regarding medication or

behavior changes.

There was concern that prescribing the comprehensive lifestyle intervention as practiced in the DPP

trial would be unrealistic, too expensive, and probably not reimbursable under our health care system.

Possibilities outside the private and public health

care system were suggested such as communitybased programs in schools and senior centers, advocacy group sponsorship, faith-based sponsorship,

employer-sponsored programs, and Federal and

State-supported prevention centers. Advocacy groups,

private foundations, and the fitness, exercise, and

food industries might also be sources of some financial support. An example given was the smoking 

cessation partnerships between physicians and the

heart and lung associations.

What Translation Strategies Are Most Effective?

The group agreed that translating research results 

is always a daunting task. The greatest asset in 

the current case is DPP’s science and impressive

results. The science and its relationship to the risk

can hopefully cut through the crowd of health 

care messages being issued today. A multi-faceted

approach was deemed necessary. The messages

should highlight that a very modest weight loss of

only 10 to 15 pounds and walking 5 days a week 

can reduce one’s risk by more than 50 percent. While

emphasizing the benefits to be gained from modest

behavior changes, the messages to health care

providers should not neglect the importance of 

the metformin intervention.
DMICC ANNUAL REPORT 88 FY 2002

The following are some of the group’s 

recommendations: 

• Keep the message simple and focused.

• “Brand” the lifestyle intervention; make it desirable

from a health, not looks, point of view; make it 

feel achievable.

• Be clear that “eat well and exercise” might be a

good message for everyone, but for the targeted

group it is of extreme importance to prevent a 

serious disease.

• Partner with other agencies and other organizations, especially local groups.

• Rely on the willingness of adults to change their

habits to benefit and protect their children and

other family members even when they are reluctant

to work to benefit themselves. This has been especially true in racial/ethnic groups.

• Use media avenues specific to professional and 

cultural groups.

• Test messages and programs with focus groups

and ask for their suggestions.

• Leverage support from celebrity spokespersons and

the fitness, sports equipment, and food industries.

• Imitate the health care marketing tactics of 

the pharmaceutical industry but with a 

smaller budget.

• Develop tools for at-risk persons to help them

achieve and maintain their goals. Suggestions

included a simple chart to show them they need 

to lose less weight than they probably think they

do; recipes for lower-fat, lower-calorie foods that

taste great; and a pedometer to track their 2,000

steps a day.

• Develop guidelines, tools, and toolkits for providers

and other health professionals to help them assess

and counsel their overweight patients.

• Develop toolkits to help local groups set up and

sponsor their “DPP Lite” program.

• Use the Internet. Ensure important websites are

easily found through search engines.

• Work with other Federal and State agencies to provide financial assistance, such as a tax break or

part of the spa fee, to help the at-risk person carry

out the lifestyle intervention.

• Work with other agencies through their programs,

such as the food stamp program and the school

food program, to provide access to lower-calorie,

lower-fat, more nutritional food.

• Work with other agencies to increase physical

activity at school and the workplace.

• Work with insurers and payers, decisionmakers

and policymakers to determine the benefits of 

prevention over the difficulties and high cost of

treating diabetes and to find ways to apply these

interventions to stem the diabetes epidemic.

What Are the Challenges?

Marketing behavior change is a difficult task. The

needed lifestyle changes will be up against society’s

current super-size everything and sedentary habits 

at work and at home. The message cannot come

across as the same old/same old. It must clearly get

across the seriousness of the targeted individual’s

ignoring the risk and not taking advantage of the

interventions. Focusing the message and relying on

the science are crucial to move over or around these

obstacles. Implementing and funding the interventions will require support outside the health care

system. People live in families, cultural groups, and

communities; therefore, these groups can inhibit or

facilitate behavior change. It will be necessary to

raise awareness, motivate them, and rely on their

resources and influence.
DMICC ANNUAL REPORT 89 FY 2002

People are not afraid of cholesterol per se. They 

are afraid of heart disease. The association between

the risk factors—being overweight, inactive, having

impaired glucose function, family history, cultural

background, and age—will have to be clearly associated with the consequences of having diabetes and

heart disease.

Common perceptions are that one must lose a lot of

weight to do any good, that any weight loss is very

difficult to achieve, and it cannot be maintained.

Inexpensive ways to highlight that a minor weight

loss is effective and to provide motivation, support

and encouragement will be needed. People are

already spending millions of dollars on diet books

and weight loss drinks and alternative drugs, and 

so on, but sustaining weight loss is what is proving

to be the big failure and the big challenge.

Translational research messages take time to 

filter down. Patience, persistence, and creativity 

will be needed.

Framework for Action and the Road Ahead

The attendees agreed that the Diabetes Prevention

Program has provided the group with an excellent

opportunity to help stem the epidemic in type 2 

diabetes. Consensus was achieved on the following

elements in the development of a framework for

action for the road ahead:

• Choose the appropriate term, pre-diabetes,

to create recognition of the risk factor.

• Focus on a high-risk population similar to that 

of the DPP volunteers.

• Provide risk assessment testing and interventions

as inexpensively as possible.

• Develop a multi-faceted translation approach.

• Establish partnerships and collaborations,

especially at the community level.

The DMICC members are taking steps to translate

the DPP science-based findings. Dr. Fradkin encouraged the DMICC members and others present to

build on their current collaborations and partnerships to translate the DPP research. She spoke enthusiastically about NIDDK’s newly designed initiatives

and planned efforts in partnership with ADA and

CDC. Dr. Fradkin also pointed out that it was important to remember that impaired glucose tolerance is

a significant risk factor for cardiovascular disease,

not the two- to four-fold risk that diabetes is, but a

50 percent elevation, which is substantial.

Dr. Spiegel summed up the success of the day’s work

by noting that many entities came together to discuss the road ahead in a challenging and productive

way. He stressed that the fact that diabetes is very

difficult and costly to treat is a compelling reason for

primary prevention. In referring to Dr. Phurrough’s

presentation, he pointed out that both financial and

human resources are needed to respond to the opportunity and challenge of translating the DPP results to

clinical practice. On the other hand, some $18 billion

a year is being spent on health care for end-stage

renal disease (ESRD), 45 percent of which is largely

due to type 2 diabetes. As the numbers of persons

with diabetes continue to grow, it can be projected

that this ESRD burden will also grow.

Dr. Spiegel said that costs saved by preventing or

delaying diabetes and its complications cannot be

saved immediately, and it is still unknown just how

effective the DPP interventions will be in the long

run, but it is daunting to consider what the numbers

and costs will be if we do not at least try. He agreed

that further followup and analysis are needed.

Dr. Garfield adjourned the meeting at 3:20 p.m.
DMICC ANNUAL REPORT 90 FY 2002

Participants

Beena Akolkar 

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

Two Democracy Plaza, Room 681

6707 Democracy Boulevard

Bethesda, MD 20892

Tel: (301) 594-8812

Fax: (301) 480-3503

ba92i@nih.gov

Richard Anderson, MD, PhD

Program Director, Division of Genetics

and Developmental Biology

National Institutes of Health

45 Center Drive, MSC 6200, Room 2AS-25

Bethesda, MD 20892-6200

Tel: (301) 594-0943

Fax: (301) 480-2228

andersor@nigms.nih.gov

Nell Armstrong, PhD, RN

Program Director

National Institutes of Health

Building 45, Room 3AN-12

45 Center Drive, MSC 6300

Bethesda, MD 20892-6300

Tel: (301) 594-5973

Fax: (301) 480-8260

nell_Armstrong@nih.gov

Kate Berg, MD, MPH

Deputy Scientific Director

National Institutes of Health

31 Center Drive, MSC 2152

Bethesda, MD 20892-2152

Tel: (301) 594-2481

Fax: (301) 402-2040

kab@helix.nih.gov

Perry Blackshear, MD, Dphil

Director, Office of Clinical Programs

National Institutes of Health

PO Box 12233

NIEHS, MD A2-05

RTP, NC 27709

Tel: (919) 541-4899

Fax: (919) 541-4571

black009@niehs.nih.gov

Susan J. Blumenthal, MD, MPA,

U.S. Assistant Surgeon General

200 Independence Avenue, SW

Room 719H

Washington, DC 20201

Tel: (202) 260-2255

SBlumenthal@osophs.dhhs.gov

Patricia S. Bryant

Director, Behavior, Health Promotion 

and Environment Program

National Institutes of Health

Building 45, Room 4AN-24, MSC 6402

Bethesda, MD 20892-6402

Tel: (301) 594-2095

Fax: (301) 480-8318

bryantp@de45.nidr.nih.gov
DMICC ANNUAL REPORT 91 FY 2002

Joan Chamberlain

Science Writer

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A04

Bethesda, MD 20892 

Fax: (301) 496-7422

Tel: (301) 435-8112

chamberlainj@extra.niddk.nih.gov

Emily Chew, MD

National Eye Institute

National Institutes of Health

Building 31, Room 6A52

31 Center Drive

Bethesda, MD 20892

Tel: (301) 496-6583

Fax: (301) 496-2297

eyc@nei.nih.gov

Michelle A. Cissell, PhD

AAAS/NIH Science Policy Fellow

Office of Scientific Program 

and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

9000 Rockville Pike

Building 31, Room 9A05

Bethesda, MD 20892-2560

Tel: (301) 496-6623

Fax: (301) 480-6741

CissellM@extra.niddk.nih.gov

Elaine Collier, MD 

Centers Program Director

Division of Allergy, Immunology,

and Transplantation

National Institutes of Health

Soar Building, Room 4a20

9000 Rockville Pike

Bethesda, MD 20892-7640

Tel: (301) 496-7104

Fax: (301) 402-2571

ecollier@niaid.nih.gov

Peter Dudley, PhD

Director, Retinal Diseases Program

National Institutes of Health

6120 Executive Boulevard, Suite 350

Rockville, MD 20892

Tel: (301) 496-0484

Fax: (301) 402-0528

pad@nei.nih.gov

Chhanda Dutta, PhD

Chief, Musculoskeletal Section and Nutrition,

Metabolism, Gastroenterology Section

Geriatrics Program

National Institutes on Health

7201 Wisconsin Avenue, Suite 3E327

Bethesda, MD 20893

Tel: (301) 435-3048

Fax: (301) 402-1784

cd23z@nih.gov

Mark Eberhardt, PhD, Epidemiologist

National Center for Health Statistics

6525 Belcrest Road, Room 730

Hyattsville, MD 20782

Phone (301) 436-5979, x142

Fax (301) 436-8459

mse1@cdc.gov
DMICC ANNUAL REPORT 92 FY 2002

Marguerite Evans

Health Science Administrator

6707 Democracy Boulevard, Room 106

Bethesda, MD 20892-5475

Tel: (301) 402-5860

Fax: (301) 480-3621

evansm@od.nih.gov

Jean L. Flagg-Newton, MD 

Deputy Director

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Suite 800

Bethesda, MD 20892

Tel: (301) 402-1366

Fax: (301) 402-7040

flaggnej@od.nih.gov

Julia Freeman, PhD 

Chief, Autoimmunity Section

National Institutes of Health

Building 45, Room 5AS-19F

45 Center Drive, MSC 6500

Bethesda, MD 20892-6500

Tel: (301) 594-5052

Fax: (301) 480-4543

freemanj@ep.niams.nih.gov

Joanne Gallivan

Director

National Diabetes Education Program

National Institutes of Health

Building 31, Room 9A04

31 Center Drive

Bethesda, MD 20892

Tel: (301) 496-6110

Fax: (301) 496-7422

joanne_gallivan@nih.gov

Rachel Greenberg

Hager Sharp

RGreenbe@hagersharp.com

Sanford Garfield, PhD, Senior Advisor,

Biometrics and Behavioral Science

National Institute of Diabetes and 

Digestive and Kidney Diseases

National Institutes of Health

Two Democracy Plaza, Room 685

6707 Democracy Boulevard

Bethesda, MD 20817

Tel: (301) 594-8803

Fax: (301) 480-3503

garfields@extra.niddk.nih.gov

Gilman D. Grave, MD

Chief, Endocrinology, Nutrition 

and Growth Branch

National Institutes of Health

9000 Rockville Pike

Bethesda, MD 20890

Tel: (301) 496-5593

Fax: (301) 480-9791

gg37v@nih.gov

Robert D. Hammond, PhD

Director, Division of Extramural Activities

National Institute of Diabetes 

and Digestive and Kidney Diseases, NIH

Two Democracy Plaza, Room 715

6707 Democracy Boulevard

Bethesda, MD 20892-5456

Tel: (301) 594-8834

Fax: (301) 480-4125

hammondr@extra.niddk.nih.gov
DMICC ANNUAL REPORT 93 FY 2002

Joan Harmon, PhD

Senior Advisor for Program & Acting Director,

Division of Bioengineering

National Institutes of Health

Building 31, Room 1B37, MSC 2077

Bethesda, MD 20892-2077

Tel: (301) 451-6772

Fax: (301) 480-4515

harmonj@nibib.nih.gov

Elke Jordan, PhD

Deputy Director

National Human Genome ResearchInstitute

National Institutes of Health

31 Center Drive, MSC 2152

Bethesda, MD 20892-2152

Tel: (301) 496-0844

Fax: (301) 402-0837

elkej@mail.nih.gov

Mary Beth Kester

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A05

Bethesda, MD 20892

Tel: (301) 496-6623

Fax: (301) 480-6741

kesterm@extra.niddk.nih.gov

Jag H. Khalsa, PhD

Pharmacologist Health Administrator

Center on AIDS and other Medical 

Consequence of Drug Abuse (CAMCODA)

National Institute on Drug Abuse

6001 Executive Boulevard

Room 5098, MSC 9593

Bethesda, MD 20892-5953

Tel: (301) 443-1801

Fax: (301) 443-4100

jk98p@nih.gov

Richard Knazek, MD

Medical Officer

Center for Research Resources

National Institutes of Health

6705 Rockledge Drive

Rockledge 1, Room 6128

Bethesda, MD 20892

Tel: (301) 435-0790

Fax: (301) 480-3661

richardk@ncrr.nih.gov

Natalie Kurinij, PhD

Program Director

Collaborative Clinical Research,

Division of Extramural Research

National Eye Institute

National Institutes of Health

Executive Plaza South, Room 350

6120 Executive Boulevard

Rockville, MD 20852

Tel: (301) 496-5983

Fax: (301) 402-0528

kurinij@nei.nih.gov

John P. Lanigan

Health Insurance Specialist

Office of Professional Relations

Centers for Medicare & Medicaid Services

Hubert Humphrey Building

Room 435H

Washington, DC 20201

Tel: (202) 690-7418

Fax: (202) 401-7438

jlanigan@hcfa.gov
DMICC ANNUAL REPORT 94 FY 2002

Saul Malozowski, MD, PhD, MBA

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

Two Democracy Plaza, Room 679

6707 Democracy Boulevard

Bethesda, MD 20892

Tel: (301) 451-4683

Fax: (301) 480-3503

sm87j@nih.gov

Nancy E. Miller, PhD

Senior Science Policy Analyst

Office of the Director

National Institutes of Health

Building 1, Room 218

Bethesda, MD 20892

Tel: (301) 594-7742

Fax: (301) 402-0280

nm68k@nih.gov

Peter Muehrer, PhD

Chief, Health and Behavioral Science

Research Branch

Division of Mental Disorders,

Behavioral Research and AIDS

National Institute of Mental Health

National Institutes of Health

6001 Executive Boulevard, Room 6189

MSC 9615

Bethesda, MD 20892-9615

Tel: (301) 443-4708

Fax: (301) 480-4415

pmuehrer@mail.nih.gov

Paul L. Nichols, PhD

Program Director, Systems 

and Cognitive Neuroscience Program

National Institute of Neurological 

Disorders and Stroke

National Institutes of Health

6001 Executive Boulevard, Room 2118

Rockville, MD 20892

Tel: (301) 496-9964

Fax: (301) 402-2060

pn13w@nih.gov

Vishnudutt Purohit, PhD

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

6000 Executive Boulevard, Suite 402

Bethesda, MD 20892

Tel: (301) 443-2689

Fax: (301) 594-0673

vpurohit@willco.niaaa.nih.gov

Peter J. Savage, MD

Acting Director, Division of Epidemiology

and Clinical Applications

National Heart, Lung and Blood Institute

National Institutes of Health

Rockledge 2, Room 8104

Bethesda, MD 20817

Tel: (301) 435-0421

Fax: (301) 480-1864

savagep@nhlbi.nih.gov

Shaio-Wei Shen, MD

Medical Officer

Division of Metabolism 

and Endocrine Drug Products

Food and Drug Administration

Parklawn Building, Room 14B-04

5600 Fishers Lane, HFD-510

Rockville, MD 20857

Tel: (301) 827-6378

Fax: (301) 443-9282

shen@cder.fda.gov
DMICC ANNUAL REPORT 95 FY 2002

Elliot R. Siegel, PhD

Associate Director of Health 

Information

Program Development

National Library of Medicine

National Institutes of Health

8600 Rockville Pike

Bethesda, MD 20817

Tel: (301) 496-8834

Fax: (301) 496-4450

siegel@nlm.nih.gov

Philip Smith, PhD

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

Two Democracy Plaza, Room 693

6707 Democracy Boulevard

Bethesda, MD 20892

Tel: (301) 594-8816

Fax: (301) 480-3503

smithp@extra.niddk.nih.gov

Mehrdad Tondravi, PhD

Program Director

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

Two Democracy Plaza, Room 603

6707 Democracy Boulevard

Bethesda, MD 20892

Tel: (301) 451-9871

Fax: (301) 480-3503

TondraviM@extra.niddk.nih.gov

Elizabeth Warren-Boulton 

Hager Sharp

Elizab@aol.com

Violet Ryo-Hwa Woo, MS, MPH

Program Analyst

Office of Minority Health

U.S. Department of Health and Human Services

5515 Security Lane, Suite 1000

Rockville, MD 20852

Tel: (301) 443-9923

Fax: (301) 443-8280

vwoo@osophs.dhhs.gov
DMICC ANNUAL REPORT 96 FY 2002

Speakers

Kelly Acton, MD, MPH

Director, National Diabetes Program

Indian Health Service

5300 Homestead Road, North East

Albuquerque, NM 87110-1293

Tel: (505) 248-4182

Fax: (505) 248-4188

Kelly.Acton@mail.ihs.gov

Kathy J. Berkowitz, RN, CS, FNP, CDE

President

Grady Health System, Diabetes Unit

American Association of Diabetes Educators

69 Butler Street South East

Atlanta, GA 30303

Tel: (404) 616-3722

Fax: (404) 616-3717

kberkow@emory.edu

Charles Clark, MD

Professor of Medicine

Indiana University School of Medicine

6055 Sunset Lane

Indianapolis, IN 46228

Tel: (317) 554-0139

Fax: (317) 554-0092

chclark@iupui.edu

Ned Calonge, MD, MPH

Chief Medical Officer

Colorado Department

of Public Health and the Environment

4300 Cherry Creek Drive South

Denver, CO 80246

Tel: (303) 692-2622

Fax: (303) 691-7702

ned.calonge@state.co.us

Jean L. Flagg-Newton, MD

Deputy Director

National Center on Minority Health 

and Health Disparities

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Suite 800

Betheda, MD 20892

Tel: (301) 402-1366

Fax: (301) 402-7040

flaggnej@od.nih.gov

Judith Fradkin, PhD

Director, Division of Diabetes,

Endocrinology, and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases, NIH

Two Democracy Plaza, Room 689

6707 Democracy Boulevard

Bethesda, MD 20892

Tel: (301) 594-8814

Fax: (301) 480-3503

fradkinj@ep.niddk.nih.gov

Richard Kahn, PhD

Scientific Chief Medical Officer

American Diabetes Association

1701 North Beauregard Street

Alexandria, VA 22311

Tel: (703) 549-1500 ext 2065

Fax: (703) 836-7439

rkahn@diabetes.org

David Marrero, PhD

Indiana University Diabetes Training 

and Research Center

250 University Boulevard, Room 122

Indianapolis, IN 46202

Tel: (317) 278-0905

Fax: (317) 278-0911

dgmarrer@iupui.edu
DMICC ANNUAL REPORT 97 FY 2002

David M. Nathan, MD

Study Chairman and Principal Investigator

Diabetes Prevention Program

55 Fruit Street

Boston, MA 02114

Tel: (617) 726-2875 or (617) 726-2066

Fax: (617) 726-6781

dnathan@partners.org

Steve E. Phurrough, MD, MPA

Director, Division of Medical 

and Surgical Services

Coverage and Analysis Group

7500 Security Boulevard

Baltimore, MD 21244

Tel: (410) 786-2281

Fax: (410) 786-9286

Sphurrough@cms.hhs.gov

Leonard M. Pogach, MD, MBA

National Program Director Diabetes

Chief, Endocrinology VA 

New Jersey Health Care System

Medical Service (111)

Diabetes Veterans Health Administration

VA Medical Center

385 Tremont Avenue

East Orange, NJ 07018

Tel: (973) 676-1000 ext.1693

Fax: (973) 395-7092

leonard.pogach@med.va.gov

Joseph V. Selby, MD

Kaiser Permanente

3505 Broadway

Oakland, CA 94611-5714

Tel: (510) 450-2106

Fax: (510) 450-2073

jvs@dor.kaiser.org

Allen M. Spiegel, MD

Director

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A52

Bethesda, MD 20892

Tel: (301) 496-5877

Fax: (301) 402-2125

spiegela@extra.niddk.nih.gov

David M. Stevens, MD, FAAFP

Director, Clinical Branch

Division of Community and Migrant Health

Health Resources and Services Administration

4350 East West Highway, 7th Floor

Bethesda, MD 20814

Tel: (301) 594-4323

Fax: (301) 594-4997

dstevens@hrsa.gov

Daniel B. Stryer, MD

Medical Officer

Center for Outcomes and Effectiveness Research

Agency for Healthcare Research and Quality

6010 Executive Boulevard, Suite 300

Rockville, MD 20852

Tel: (301) 594-4038

Fax: (301) 594-3211

dstryer@ahrq.gov

Frank Vinicor, MD, MPH

Director

Division of Diabetes Translation (K-10)

Centers for Disease Control and Prevention

4770 Buford Highway

Atlanta, GA 30341-3717

Tel: (770) 488-5000

Fax: (770) 488-5966

fxv1@CDC.GOV
DMICC ANNUAL REPORT 99 FY 2002

DMICC: MACROVASCULAR DISEASE & DIABETES:

TRANSLATION ISSUES

July 15, 2002

NIH Campus, Building 31c, 6th Floor, Room 6

Bethesda, Maryland

Introduction

Dr. Sanford Garfield, Executive Secretary, DMICC,

opened the meeting and introduced Dr. Allen Spiegel,

Director of the NIDDK and Chairman of the Diabetes

Mellitus Interagency Coordinating Committee

(DMICC). Citing data that indicates an increased relative risk of cardiovascular disease (CVD) for those

individuals who have been diagnosed with diabetes

or pre-diabetes, Dr. Spiegel defined the purpose of the

meeting: To determine the means and methods for

translating the current scientific data from clinical

trials and epidemiological studies to diabetic patients and the general public. Dr. Spiegel also took 

the opportunity to introduce Dr. Claude Lenfant,

Director of the National Heart, Lung and Blood Institute (NHLBI), who further emphasized the need for

translation efforts involving CVD and diabetes.

Diabetes and Macrovascular Disease: 

Scope of the Problem

Dr. Hertzel Gerstein, Professor of Clinical Epidemiology and Biostatistics and Medicine at McMaster

University, Hamilton, Ontario, Canada, examined the

increased relative risk of a macrovascular event in

subjects with diabetes. CVD must be considered as 

a risk factor for people with diabetes, since 70 percent of diabetic subjects die of cardiovascular causes, and CVD represents more than two-thirds of the

greater than $100 billion per year diabetes costs in

the U.S. alone.

Data from clinical studies show that diabetes in 

men increases the relative risk of a CVD event twoto three-fold; in women the risk is increased from

two- to five-fold. The OASIS database indicates 

that having diabetes at the time of admission for

unstable angina predicts a higher risk of mortality.

Even having experienced a previous myocardial

infarction (MI) presents less risk than does having

diabetes alone.

The absolute risk of a cardiovascular (CV) event 

in people with diabetes is difficult to accurately 

predict. Although less than ideal, the best data is

obtained from clinical trial databases. Dr. Hertzel

summarized data from the HOPE, RENAAL, IDNT,

IRMA, and HPS studies, concluding that a person

with diabetes and no previous CV event may have 

a risk equivalent to a non-diabetic subject who 

has experienced a CV event.

Blood glucose levels of >133 mg/dl and elevated

hemoglobin A1c are consistently predictive of CV

risk, independent of diabetes. Since these risk factors extend well below the diabetes threshold, Dr.

Gerstein asserted that the prevalence of metabolic

problems in the general public foretells a much 

larger epidemic of CVD.
DMICC ANNUAL REPORT 100 FY 2002

Recent Clinical Trials: Projected Benefits

Dr. Steven M. Haffner, Professor of Internal Medicine

at the University of Texas Health Science Center in

San Antonio, Texas, reviewed recent clinical trials in

the area of CVD and diabetes translation research.

Dr. Haffner recommended that the focus of NIH

strategy be on the primary prevention of diabetes

for two reasons: 1) diabetic subjects have a high

mortality rate within 1 year of their first MI, and 

2) diabetics develop CVD at twice the rate of those

individuals who are never diagnosed with diabetes.

Current clinical trials such as the ACCORD, Look

AHEAD, and BARI studies are examining hemoglobin A1c, blood pressure, LDL, HDL, and smoking as

risk factors. Clearly, data from these trials show

that these conventional risk factors predict CV risk

within diabetic subjects. Data further suggests that

ACEs, ARBs, statins, and antihypertensive agents are

particularly promising pharmacologic interventions.

The heterogeneity of the risk in diabetics for CVD 

is evidenced by data indicating that subjects with

metabolic syndrome have an intermediate risk of

CVD. Eighty-five percent of diabetic subjects have

metabolic syndrome and a subsequent two-fold

greater risk for CVD than do diabetics without

metabolic syndrome.

Dr. Haffner emphasized that a multifactorial

approach in clinical trials will be necessary to halt

the CVD epidemic, one which addresses the prevention of type 2 diabetes, as well as the improvement

and treatment of the disease, including examination

of improved glycemic control, risk factor management, and special interventions.

Economics of the Problem

Dr. Vinkat Narayan, Chief of the Epidemiology

Section at the Centers for Disease Control and Prevention (CDC), addressed the economics of diabetes

and CVD translational research and application. The

interaction of diabetes and CVD has a huge impact

on the cost of health service in the U.S. Direct costs

of diabetes are estimated at $44 billion per year,

and CVD at $8 billion; of that, 56 percent of deaths

and 55 percent of lost productivity are attributed to

CVD. At all ages, the impact of CVD is substantial.

Although the direct cost of diabetes in terms of

medical expenses is but a small component, the indirect costs (i.e., mortality costs) are substantial.

Among people with diabetes, macrovascular complications account for a large percentage of total costs.

Total lifetime costs of diabetes are probably underestimated at $82,000. This figure decreases with age,

since younger individuals have longer lifetime exposure to risk of complications, and argues for better

screening for diabetes at younger age levels.

QALY, which incorporates mortality, morbidity,

and quality of life, is an important measurement

tool. Data from the UKPDS study among others 

show that, per $1.00 of investment, blood pressure

control is a clearly superior investment, although

glycemic control may be more beneficial in younger

age groups. Dr. Narayan suggested that other interventions, such as ACE inhibitors and aspirin use,

should be more closely evaluated.

Diabetes Translation: 

The Challenge for Primary Care

Dr. Evan Benjamin of the Bayside Medical Center,

Springfield, Massachusetts, identified safety in

health care as one of the challenges of providing

comprehensive health care to patients. Misuse,

underuse, and overuse of treatment are components

that ought to be addressed in the health care system.
DMICC ANNUAL REPORT 101 FY 2002

Although ultimately we ought to seek to prevent 

diabetes, our immediate goal must be to get treatment to patients with diabetes. Aggressive goals 

for blood pressure, LDL, hemoglobin A1c, aspirin,

and anti-platelet therapies are laudable, but are 

not widely or consistently attained among diabetic

patients, let alone the general population. In a

Massachusetts General Hospital study, 92 percent 

of patients diagnosed with diabetes had A1c determined and 99 percent had blood pressure readings

taken. However, only 76 percent had their cholesterol

tested and just 61 percent had a fasting lipid profile

for LDL. Of those tested, the majority were above the

target levels, reflecting an underuse of testing for

risk factors in diabetic subjects.

The message regarding aggressive treatment regarding blood pressure and lowered lipid levels has 

been well received by both physicians and patients.

However, problems in translation persist in the

areas of knowledge and attitude among physicians,

systems issues, and patient adherence to treatment

plans. Without clear guidelines for health care 

providers, physicians must rely on computerized

systems or diabetes registries for standards. Alternatively, patients must be directly instructed 

by the health care system as to how to recognize

the standards and demand the necessary treatment

for high quality diabetes care.

Dr. Benjamin cited the diabetes clinic approach used

by the Indian Health Service and Kaiser Permanente,

which focuses on diabetes, glycemic control, blood

pressure, lipid levels, standards of care, and secondary prevention related to diabetes as well as CVD, as

being an effective tool that all health care systems

ought to consider.

The Drug Industry and Its Role in Translation

Dr. Fred Fiedorek, Vice President of the Metabolics,

Clinical Development, and Life Cycle Management

Division, Pharmaceutical Research Institute at

Bristol-Myers Squibb, related the current focus of

the drug industry as the determination of surrogates

that will lead to event reduction in clinical trials

and clinical practice.

The drug industry is focusing on the metabolic syndrome because of concern that these are the events

that most impact not only patients with diabetes,

but those in the 10- to 15-year period prior to diagnosis. Those in the drug industry recognize that a

balance of benefit and costs associated with risk is

an important consideration where patients taking

multiple medications are concerned.

To that end, Dr. Fiedorek suggests that two approaches be followed: 1) to do innovative science to

understand core mechanisms underlying diabetes

and how it is linked to CVD, and 2) to investigate

“killer applications” (research of the use of multiple

medications as effective treatment).

The drug industry grants the importance of prevention as well as drug therapy such as metformin,

pravastatin, and aspirin-drug combinations; the

investigation of metabolic syndrome; and the need

for translation. However, the past emphasis on

glycemic ranges may need to be downplayed, since

diabetes does not involve simply a problem with

sugar, but more precisely relates to an increased risk

of CVD, together with its inherent health hazards.
DMICC ANNUAL REPORT 102 FY 2002

The Managed Care Perspective

Dr. Joseph V. Selby, physician, health services

researcher, and Director of the Division of Research

at Kaiser Permanente in Northern California, presented the managed care perspective on diabetes,

macrovascular disease, and translation. The prevalence of diabetes within the Kaiser Permanente 

population has risen 33 percent in the past 5 years,

while coronary heart disease and congestive heart

failure rates have remained stable.

Although hospitalization costs for diabetic patients

have decreased slightly over the past 5 years, the

current focus on lowering blood pressure and lipid

levels has contributed to a significant rise in laboratory testing and pharmaceuticals, keeping overall

costs relatively neutral. Still, health care costs for

diabetic patients are significantly greater than for

non-diabetics. Dr. Selby emphasized the importance

of good disease management in reducing health care

costs and recommended a systems approach to identify populations; to provide decision support, monitoring, and feedback on performance and outcomes;

and to ensure that the highest risk patients receive

the most intensive efforts.

The high co-occurrence rates of hypertension and

dyslipidemia among diabetic patients suggests the

benefit in risk-stratifying populations of diabetic

patients lies in being able to identify subgroups having an increased risk of metabolic syndrome and

accompanying complications. Using a multivariate

model, Kaiser Permanente has identified three predictors that a patient with no previous event would

suffer a major micro/macrovascular, infectious, or

metabolic event within 12 months: 1) elevated serum

creatinine levels, 2) use of two blood pressure medications, and 3) use of insulin.

Kaiser Permanente is currently expanding the 

training and responsibilities of diabetes nurse care

managers to include CVD risk factor management

and plans to re-design risk stratification algorithms

to incorporate findings from the risk predictor study.

Future and ongoing research will evaluate trends 

in coronary artery disease (CAD) and stroke incidence over time, with a particular focus on possible

increases in end-stage renal disease (ESRD) as

macrovascular disease rates decline.

Agency Overviews on Macrovascular Disease and

Diabetes and Translation Issues

National Diabetes Education Program (NDEP)

Dr. Judith Fradkin, Director of Diabetes, Endocrinology and Metabolic Diseases, National Institute 

of Diabetes and Digestive and Kidney Diseases

(NIDDK), presented an update on the National Diabetes Education Program with regard to cardiovascular issues.

The NDEP is committed to expanding the glucocentric message to include more comprehensive care 

for patients with diabetes, with a particular focus 

on cardiovascular disease. The NDEP’s ABC (A1c,

blood pressure, and cholesterol) Campaign targets

patients and is, therefore, complementary to the

American Diabetes Association’s (ADA) Make The

Link Program, which is primarily aimed at health

care providers.

A joint press conference with ADA emphasizing that

two-thirds of patients with diabetes are unaware

that CVD is the major source of mortality for diabetics generated a fair amount of publicity. Information

is being disseminated through a variety of media,

including the NDEP Web site, community publications, and television and radio news broadcasts.
DMICC ANNUAL REPORT 103 FY 2002

Most recently, NDEP has turned its efforts toward

sub-populations, such as African Americans, Asian

Americans, and women.

National High Blood Pressure Education Program

(NHBPEP)

Dr. Jeffrey Cutler discussed the translation efforts 

of the National High Blood Pressure Education

Program. The NHBPEP, overseen by a coordinating

committee comprised of approximately 45 members

representing professional and volunteer organizations, as well as Government agencies, has recommended aggressive treatment of high blood pressure

among patients with diabetes. While lifestyle

changes, weight control, and increased physical

activities are interventions that have been promoted

for many years, new emphasis has been applied 

to the prevention of hypertension and diabetes.

Previously, treatment goals for hypertensive diabetic

patients were determined strictly on risk considerations and lacked a basis in trial data. However, more

recent trials have provided evidence of the improved

effectiveness of beta blockers over earlier drug 

interventions and have identified diabetic patients

as the high-risk level, resulting in the recommendation of immediate drug treatment initiation for 

those patients.

Most information regarding hypertension guidelines

is shared internationally, and a broad awareness of

the principles are apparent, even if their implementation is less clear.

Since the benefits from the treatment and control 

of high blood pressure seem to be leveling off, the

NHBPEP is concentrating efforts in a new direction,

including work with the National Committee on

Quality Assurance, to adopt a HEDIS or control 

standard aimed at the CVD high risk populations.

NHBPEP is also involved in contracts with the 

community-based consortia, or dissemination-utilization center, whose goal is to provide for CVD

high-risk populations.

National Cholesterol Education Program (NCEP)

Dr. James Cleeman, Coordinator of the NCEP, discussed the translational efforts of the program with

respect to diabetes. Dr. Cleeman explained that science must first be translated into guidelines for 

professionals before those guidelines can be extended into useful tools for health care professionals,

patients, and the public.

The Adult Treatment Panel III (ATP III) Study regards

diabetes as a coronary heart disease (CHD) risk

equivalent. Within the study’s statin trials, over 20

percent of those subjects in the placebo group suffered an MI plus coronary death within a 10-year

period. In comparison, 15 to 25 percent of diabetic

patients are at risk of developing CHD.

Data from the Heart Protection Study, which examined the effects of therapeutic lifestyle changes and

the LDL level at which drug therapy ought to be considered, is currently being evaluated.

ATP III derived therapeutic objectives for metabolic

syndrome, including the reduction of underlying

causes (i.e., obesity and a sedentary lifestyle). The

study produced an executive summary published by

JAMA and a Quick Desk Reference (the ATP III AtA-Glance, which provides treatment instructions).

These reference materials have been augmented by 

a NHLBI Web site, patient brochures, kits sent to

65,000 physicians, a palm device program, and

implementation of National Cholesterol Education

Month, all of which emphasize diabetes as a coronary disease equivalent.
DMICC ANNUAL REPORT 104 FY 2002

Centers for Medicare & Medicaid Services (CMS)

Dr. Steve Phurrough, Director, Division of Medical

and Surgical Services of the Coverage and Analysis

Group, addressed the translation efforts of CMS.

Medicare was authorized by Congress to pay for the

diagnosis and treatment of injury and disease, covering 34 million Americans at an annual cost of $300

million. While coverage originally excluded screening or prevention, over the past decade, Congress

has approved some limited screening procedures.

For diabetic patients, coverage has generally been

available for secondary prevention in macrovascular

care, since secondary prevention is considered the

treatment of a primary disease. Coverage has recently been expanded to include nutritional counseling,

selected foot exams, and a 10-hour diabetes education program. Medical benefits may also be covered

in the future. However, translation at CMS remains

an issue of coverage.

Currently, CMS publishes several pamphlets and

manuals made available to both health care

providers and patients. The agency is investigating

the level and causes of disparities in diabetes treatment between gender, racial, and ethnic groups.

Indian Health Service (IHS)

Dr. Kelly Acton, Director of the National Diabetes

Program at the IHS, spoke about the agency’s

approach to macrovascular disease and translation

activities in terms of risk factors. CVD and cerebrovascular disease mortality rates in American

Indians and Alaska Natives, although variable

between tribes, exceed all other races in the U.S.

combined. The Strong Heart Study, an NHLBI-funded, longitudinal study of CVD in 13 American Indian

tribes, produced data showing diabetes is second

only to age as the strongest determinant of CVD.

IHS updates its standards for care every 2 years and

has recently instituted the CVD Risk Factor Report,

a subreport from the agency’s annual diabetes care

and outcome audit, which calculates CV risk status

for individual facilities, as well as for regions. Data

from this report shows a substantial increase in the

number of people within the population who are

tobacco-free. Aspirin use has increased over the past

2 years as a result of changes in IHS standards of

care. Levels of glycemic control, blood pressure,

LDL and HDL, triglycerides, and albuminuria, while

increasingly favorable, still present an area for improvement. The population continues to show a 

significant problem with obesity.

IHS targets the highest risk individuals, utilizing a

systems approach with diabetes clinics in nearly

every facility, electronic registries, and standards 

of care. Currently, IHS is gathering age-specific diabetes prevalence data.

Veterans Administration (VA)

Dr. Leonard Pogach, National Program Director 

for Diabetes for the Veterans Health Administration

and Chief of Endocrinology for the VA Health Care

System, offered information regarding cardiovascular prevalence, risk factors, and outcomes in the VA

health care system. The VA health care system is a

nationwide system that includes clinical reminders

and an emphasis on prevention, care coordination,

and chronic disease management. It provides health

care services for a relatively challenged population,

40 percent of whom have known CVD.

To improve quality of care for its patients, the 

VA instituted the Quality Enhancement Research

Initiative (QUERI) program in 1999, using health

services research in its system for translation,

feedback, and evaluation. Primarily, effort has been

focused on ongoing organizational improvements

and integration with existing tools, especially using

the VA’s electronic databases, with the goal of inducing behavioral changes within the population.
DMICC ANNUAL REPORT 105 FY 2002

Aspirin use and maximal hypertension therapy

(defined as three or more medications) interventions

have shown promising results in lowering the incidence of hypertension among VA patients. Health

care providers using the VA computer system are

presented with reminders for blood pressure and

lipid levels. Pilot data indicates clinicians are 

responding by entering data and making an 

appropriate intervention.

Centers for Disease Control and Prevention (CDC)

Dr. Frank Vinicor, Director of Diabetes Translation 

at CDC, suggested that the diabetes epidemic may

cause a neutralization of the benefits of lowering

blood pressure and lipid levels, together with a 

corresponding increase in CVD associated with 

diabetes.

Dr. Vinicor stressed the importance of science in

underpinning public health translation approaches,

since absent the essential scientific basis, controversies regarding treatment and programs will arise.

Dr. Vinicor raised the issue that discussion of 

CVD ought to focus on the large percentage of time

patients spend away from their doctors or health

care professionals, and that rather than making 

the best treatment available to a small number of

diabetic patients, it would be better to make a good

treatment available to many, at least insofar as CVD

is concerned.

At CDC, the focus is currently on 1) collection of 

data from national sources such as the Diabetes

Quality Improvement Program, 2) examination of 

the issue of proper CVD care for diabetics through

systems of care and the development of health care

workers as an essential part of the health care 

team, and 3) comprehensive diabetes control programs concerned with health systems changes,

community interventions, and health communications. Future CDC endeavors include establishing 

a better definition of diabetes and examination of

the metabolic syndrome.

Other Translation Efforts

Following the presentations by invited speakers,

Dr. Garfield invited representatives from various

agencies and associations to share current 

translational efforts.

Dr. Daniel Stryer, Center for Outcomes and

Effectiveness Research, Agency for Healthcare

Research and Quality (AHRQ), informed the group

that AHRQ is conducting studies examining the

impact of diabetes policies, disparities in diabetes,

and systems level changes, including disease management programs and the use of diabetic clinics

and automated telephone assessment and reminder

systems. Implementation research includes TRIP

studies (Translating Research Into Practice), such as

the impact of opinion leaders, academic detailing,

and patient empowerment tools. AHRQ’s National

Guidelines Clearinghouse puts guidelines into the

public domain, making the information easily accessible. Data networks and surveys are also available.

Dr. Robert Misbin, Medical Officer of the Division 

of Endocrine and Metabolic Products, Center for

Drug Evaluation and Research at the Food and 

Drug Administration, highlighted studies being conducted by the pharmaceutical industry regarding 

the benefit of treating insulin resistance with respect to hard endpoints.

Dr. Nathaniel Clark, National Vice President of

Clinical Affairs at the American Diabetes Association, stressed the need for consistent, evidencebased, and achievable guidelines. Current projects

involve issues of optimal lipid levels in children 

and the construction of guidelines for children 

with type 1 diabetes.
DMICC ANNUAL REPORT 106 FY 2002

Dr. Robert Eckel, of the American Heart Association

(AHA), expressed his association’s goal that by 2010

morbidity and mortality from heart disease and

stroke be reduced by 25 percent, and risk factors for

heart disease and stroke also be reduced by 25 percent. To accomplish their goal, the AHA has placed 

a very high priority on understanding the connection

between obesity and diabetes. Information from

research and the agency’s progress has culminated

in several prevention conferences.

Panel Discussion

During the Panel Discussion, the following questions

were raised:

• What, if any, are the public health responsibilities

of agencies that are not public health agencies?

• How will the health care of patients with 

more than one chronic disease be effectively 

coordinated?

• How can agencies coordinate efforts on translation

research in order to perform larger, more 

efficient studies?

• How can patients be risk-stratified so that translation efforts can be made more immediately usable?

• Would a trial research network be feasible?

• Given the accessibility to care and medications,

why are patients not achieving goals?

• If interventions are effective, are they additive 

or subadditive?

SUMMARY

Participants reached a general consensus in recognizing that primary prevention research in the areas

of diabetes and CVD will provide the greatest benefit

for translation efforts. Future research in the following areas is therefore warranted:

I. Interventions

• Examination of pharmacologics, particularly ACEs,

ARBs, statins, and antihypertensive agents.

• Determination of the benefits of glycemic control

versus CV risk reduction.

• Investigation of multiple drug therapy and its

metabolic effects.

• Identification of the underuse and misuse of 

pharmacologic therapies.

• Assessment of the effects of underuse of specific

patient exams, such as A1cs, eye exams, and 

foot exams.

II. Health Care Costs/Economics

• Institution of incentives for health care providers.

• Promotion of earlier screening for younger 

subjects, in an effort to reduce lifetime costs.

• Examination of costs over a finite time period 

versus lifetime costs.

• Prospective data collection of costs in 

clinical trials.
DMICC ANNUAL REPORT 107 FY 2002

It was strongly emphasized that extensive research

efforts are demanded in the area of metabolic syndrome and its connection to diabetes and cardiovascular disease. Additionally, disparity issues between

gender, race, and ethnicity must be addressed.

The traditional emphasis on metabolic control,

while certainly effective to some degree, must be

expanded to include CV risk reduction, such as

boold pressure control and lowering of cholesterol

levels. In order to go beyond the current levels of

prevention and increase the effectiveness of treatment, the message must be expanded to include 

CV risk reduction.

It was noted that not all failure of individuals to

achieve target levels is due to faults in the health

care system or providers. There are important gaps

in knowledge of the epidemiology of diabetes as a

CV risk factor. Research efforts directed at promoting a system approach may correct the current

paucity of databases available, as well as facilitate

large outcome trials. Clinical reminders (i.e., those

promoting aspirin use) are relatively easy to implement and have shown a good measure of success

with respect to health care provider and patient use.

As the message to be portrayed is more clearly

defined, tools such as Quick References and Web

sites ought to be put into place. Doing so will not

only impart diagnostic and treatment data to health

care professionals, but perhaps more importantly

will place information in the hands of patients and

the general public.
DMICC ANNUAL REPORT 108 FY 2002

Participants

Kristin Abraham, PhD

Director, Cell Signaling Programs

Division of Diabetes, Endocrinology 

and Metabolic Disease

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza, Room 607

Bethesda, MD 20892

Tel: (301) 451-8048

Fax: (301) 480-3503

abrahamk@extra.niddk.nih.gov

Beena Akolkar, PhD

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 681

Bethesda, MD 20892

Tel: (301) 594-8812

Fax: (301) 480-3503

ba92i@nih.gov

Barbara Alving, MD

Deputy Director

National Heart, Lung and Blood Institute

National Institutes of Health

31 Center Drive

Building 31, Room 5A47, MSC 2490

Bethesda, MD 20892

Tel: (301) 594-5171

Fax: (301) 402-0818

alvingb@nhlbi.nih.gov

Diane M. Canova, Esq.

Vice President of Advocacy

Office of Public Advocacy

American Heart Assocation

1150 Connecticut Avenue NW, #300

Washington, DC 20036

diane.canova@heart.org

Michelle Cissell, PhD

AAAS/NIH Science Policy Fellow

Office of Scientific Program and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A05

Bethesda, MD 20892

Tel: (301) 496-6623

Fax: (301) 480-6741

cissellm@extra.niddk.nih.gov

Nathaniel Clark, MS, RD, MD

National Vice President, Clinical Affairs

American Diabetes Association

1701 North Beauregard Street

Alexandria, VA 22311

Tel: (703) 299-5533

Fax: (703)549-1715

nclark@diabetes.org

Catherine Cowie, PhD

Director, Type 1 Diabetes Clinical Trials Program

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza, Room 691

Bethesda, MD 28092-5460

Tel: (301) 594-8804

Fax: (301) 480-3503

cowiec@extra.niddk.nih.gov
DMICC ANNUAL REPORT 109 FY 2002

Joel Finkelstein 

Science Writer

Center for the Advancement of Health

2000 Florida Avenue, Suite 210

Washington, DC 20009

Tel: (202) 387-2829

Fax: (202) 387-2857

jfinkelstein@cfah.org

Joanne Gallivan 

Director, National Diabetes Education Program

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A04

Bethesda, MD 20892

Tel: (301) 496-6110

Fax: (301) 496-7422

joanne_gallivan@nih.gov

Robert D. Hammond, PhD

Director, Division of Extramural Activities

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza, Room 715

Bethesda, MD 20892-5456

Tel: (301) 594-8834

Fax: (301) 480-4125

hammondr@extra.niddk.nih.gov

Barbara Harrison 

Director, Obesity Special Projects Program

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

Room 661, MSC 5450

Bethesda, MD 20892-5450

Tel: (301) 594-8858

Fax: (301) 480-8300

harrisonb@extra.niddk.nih.gov

Joyce Hunter, PhD

Deputy Director, Division of Extramural Activities

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

Bethesda, MD 20892

Tel: (301) 594-0056

hunterj@extra.niddk.nih.gov

Mary Beth Kester

Program Analyst

Office of Scientific Program and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive, Room 9A05

Bethesda, MD 20892

Tel: (301) 496-6623

Fax: (301) 480-6741

kesterm@extra.niddk.nih.gov

Maren R. Laughlin, PhD

Director, Metabolism Program,

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza, Room 6101

Bethesda, MD 20892-5460

Tel: (301) 594-8802

Fax: (301) 480-3503

maren.laughlin@nih.gov
DMICC ANNUAL REPORT 110 FY 2002

Barbara Linder, MD, PhD

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 699

Bethesda, MD 20892

Tel: (301) 594-0021

Fax: (301) 480-3503

linderb@extra.niddk.nih.gov

Saul Malozowski, MD, PhD, MBA

Senior Advisor for Clinical Trials 

and Diabetes Translation

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 679

Bethesda, MD 20892

Tel: (301) 451-4683

Fax: (301) 480-3503

malozowskis@extra.niddk.nih.gov

Robert Misbin, MD

Medical Officer

Division of Endocrine and Metabolic Products

Center for Drug Evaluation and Research

Food and Drug Administration

Tel: (301) 443-9282

misbinr@cder.fda.gov

Salvatore Sechi, PhD

Director, Proteomic Program

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 611

Bethesda, MD 20892-5460

Tel: (301) 594-8814

Fax: (301) 480-2688

Salvatore_Sechi@nih.gov

Denise Simons-Morton, MD, PhD

Acting Director, Clinical Applications 

and Prevention Programs

Division of Epidemiology and Clinical Applications

National Heart, Lung and Blood Institute

National Institutes of Health

6701 Rockledge Drive, MSC 7936, Room 8138

Bethesda, MD 20892-7936

Tel: (301) 435-0384

Fax: (301) 480-1669

simonsd@nhlbi.nih.gov

Elizabeth Singer

Director, Office of Communicatoins 

and Public Liaison

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive, Room 9A04

Bethesda, MD 20892

Tel: (301) 496-3583

elizabeth_singer@nih.gov

Susan Yanovski, MD

Director, Obesity and Eating Disorders Program

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 665

Bethesda, MD 20892

Tel: (301) 594-8882

Fax: (301) 480-8300

yanovskis@extra.niddk.nih.gov
DMICC ANNUAL REPORT 111 FY 2002

Speakers

Evan Benjamin, MD 

Baystate Medical Center

759 Chestnut Street

Springfield, MA 01199

Tel: (413) 794-2527

evan.benjamin@bhs.org

James Cleeman, MD

Coordinator, National Cholesterol 

Education Program

National Heart, Lung and Blood Institute

National Institutes of Health

Building 31, Room 4A16

Bethesda, MD 20892

Tel: (301) 496-1051

Fax: (301) 402-1051

cleemanj@nhlbi.nih.gov

Fred Fiedorek, MD

Vice President, Metabolics, Clinical Development 

and Life Cycle Management, Pharmaceutical 

Research Institute

Bristol-Myers Squibb

3551 Lawrenceville Road

Princeton, NJ 08540-4700

Tel: (609) 252-4897

Fax: (609) 252-6791

fred.fiedorek@bms.com

Hertzel Gerstein, MD

Professor (Associate)

Clinical Epidemiology and 

Biostatistics and Medicine

Faculty of Health Sciences

McMaster University

Health Sciences Centre, Room 3V38

1200 Main Street West

Hamilton, Ontario 

CANADA

Tel: (905) 525-9140 x73371

Fax: (905) 521-4971

gerstein@mcmaster.ca

Steven M. Haffner, MD

Professor, Department of Medicine

Department of Medicine

Division of Clinical Epidemiology

The University of Texas Health Science Center

San Antonio, TX 78229-3900

Tel: (210) 567-4737

Fax: (210) 567-6955

haffner@uthscsa.edu

Claude Lenfant, MD

Director, National Heart, Lung 

and Blood Institute

National Institutes of Health

31 Center Drive

Building 31, Room 5A-52

Bethesda, MD 20892

Tel: (301) 496-5166

Fax: (301) 402-0818

lenfantc@nhlbi.nih.gov

Vinkat Narayan, MD

Chief, Diabetes Epidemiology Section

Division of Diabetes Translation

Centers for Disease Control and Prevention

2858 Woodcock Boulevard, MS K10

Atlanta, GA 30341

Tel: (770) 488-1051

kav4@cdc.gov

Steve Phurrough, MD, MPA

Director, Division of Medical 

and Surgical Services

Coverage and Analysis Group

7500 Security Boulevard

Baltimore, MD 21244

Tel: (410) 786-2281

Fax: (410) 786-9286

sphyrrough@cms.hhs.gov
DMICC ANNUAL REPORT 112 FY 2002

Joseph V. Selby, MD

Kaiser Permanente

3505 Broadway

Oakland, CA 94611-5714

Tel: (510) 450-2106

Fax: (510)450-2073

jvs@dor.kaiser.org

Theresa Watkins-Bryant, MD

Chief, Perinatal and Child Health Branch, BPHC

Health Resources and Services Administration

U.S. Department of Health and Human Services

9-10A4 EWT

Bethesda, MD 20814

Tel: (301) 594-4423

TWatkins-Bryant@HRSA.gov
DMICC ANNUAL REPORT 113 FY 2002

DMICC: THE SCIENCE OF TRANSLATION

RESEARCH: OUTCOMES AND OPPORTUNITIES

September 27, 2002

National Institutes of Health

Bethesda, Maryland

Introduction

Dr. Sanford Garfield, Executive Secretary of DMICC,

opened the meeting and announced that Dr. Saul

Malozowski, Senior Advisor for Clinical Trials and

Diabetes Translation, National Institute of Diabetes

and Digestive and Kidney Diseases (NIDDK), would

become the new Executive Secretary at the next

DMICC meeting. Dr. Allen Spiegel, NIDDK Director,

welcomed the attendees and stated "NIDDK's mission is to conduct and support research on diseases

such as diabetes in order to increase knowledge 

to improve the public's health. NIDDK's goals will

not be completely achieved until the knowledge

gained from the research it supports is translated

and fully applied."

Dr. Spiegel pointed out that understanding translation can sometimes be confusing because it is made

up of two blocks. The first block is “from bench to

bedside,” from laboratory research to impacting on

the patient’s care. The focus of this meeting was the

second translational block, the science of translation

research that goes from scientific understanding to

adoption and community practice. He emphasized

that there is no sharp demarcation in the NIH 

mission; rather it is a continuum, a critical aspect 

of which is the partnership with academic partners

and agencies of the U.S. Department of Health and

Human Services (DHHS), many of whose members

were represented in the audience. Dr. Spiegel said

that the role of DMICC is to ensure that the entire

continuum is realized from the most basic NIHsupported research out to the distal levels of clinical

care, quality of care, and application. This meeting

celebrates the 25th anniversary of the Diabetes Research and Training Centers (DRTCs) program and

the initiation of the translation activities mandated

to be a part of these DRTCs.

Dr. Spiegel also announced that Dr. Judith Fradkin,

Director of NIDDK’s Division of Diabetes, Epidemiology, and Metabolism, is the recipient of the 2003

American Medical Association’s Nathan Davis Award

for Career, Executive Branch, Public Service, a Government-wide award that recognizes her role as 

co-chairperson of the National Diabetes Education

Program (NDEP) and in the framing of a transNIH strategic plan for diabetes research, and for 

her efforts, along with that of other NIDDK program

staff, with the 1999 congressionally mandated Diabetes Research Working Group (DRWG) for research

planning in type 1 and type 2 diabetes. DMICC participants received copies of a draft Executive Summary of the updated DRWG report and a summary 

of the May 16, 2002, meeting of external advisors on

the special statutory funding program for type 1 

diabetes research.
DMICC ANNUAL REPORT 114 FY 2002

Morning Presentations and Discussions

National Diabetes Mellitus Research and

Education Act, Diabetes Research and Training

Centers, and Diabetes Translation— 

The First 25 Years

Dr. Roland “Red” Hiss, Director of Prevention and

Control Division of the Michigan DRTC, University 

of Michigan Medical School, Ann Arbor, presented an

historical overview of the DRTCs and their role in

translation research, beginning with the National

Diabetes Mellitus Research and Education Act of 19-

74 (Public Law 93-354, July 23, 1974). This far-reaching and informed act enacted by the 93rd Congress

resulted from a 1970’s national groundswell that 

was beginning to recognize diabetes as a serious disease, as had happened previously with hypertension.

The Act established the regional DRTCs and recommended establishment of a National Commission 

on Diabetes to develop a long-range plan to combat

diabetes. The Act also established the DMICC. In December 1975, the Commission, chaired by Dr. Oscar

Crofford, submitted a four-part report consisting of

nine volumes. The first volume was the mandated

long-range plan, updated in 1976. The plan was intended to expand and coordinate national research

on diabetes; advance the education of patients,

health professionals, and the general public; and 

disseminate updated information.

The NIH agencies impacted by the report included

the National Institute of Arthritis, Metabolism,

and Digestive Disorders (NIAMDD, now NIDDK); the

National Eye Institute (NEI); the National Institute 

of Neurological and Communicative Disorders and

Stroke; the National Institute of Dental Research; 

the National Institute of Child Health and Human

Development; the National Heart and Lung Institute

(now the National Heart, Lung, and Blood Institute

(NHLBI)); and the National Institute of Mental Health

(NIMH). Inclusion of NIMH suggested that research

be conducted on the behavioral aspects of diabetes.

Also included was the Center for Disease Control

(now CDC, the Centers for Disease Control and

Prevention); the Veterans Administration; and the

Bureaus of Indian Affairs, Quality Assurance, and

Community Health Services. The report recommended

the creation of a National Diabetes Data Group, the

National Diabetes Information and Education Clearinghouse, and the CDC Diabetes Control Programs 

in each of the States’ departments of health.The first

Request for Applications (RFA) for a DRTC was

issued in June 1976 by NIAMDD. The RFA stated two

principal functions—research and translation. It

stated that a key function “will be to translate, rapidly and effectively, appropriate results of research into

health care so that particular activities can become

standard practice, not only in the community in

which it is demonstrated, but in other communities

as well.” Dr. Hiss said that the statement sounds

clear, but it was not. For some 10 years, “what is

translation” was argued about at site visits and

annual meetings. He pointed out that we have come 

a long way from that early concept.

Dr. Hiss mentioned a number of barriers to adoption

of new science and to the development of consensus

regarding the science’s message in its adaptation 

to clinical care and practice. Among these barriers

are the asymptomatic nature of diabetes; attitudes,

beliefs, and misconceptions on the part of clinicians

and patients; the health care system’s emphasis on

acute, not chronic illness, and health care economics;

the influence of obesity; and the difficulties of instituting and maintaining behavior change in adults.

He stressed the importance of consensus in delivering a clear message and the resistance created by

mixed messages from different groups. Following

barrier identification, the big challenge is barrier

removal or circumvention. Incorporation of feedback

from clinicians and patients is also necessary.
Asked to provide an example of a good piece of 

science that has become bogged down in barriers,

Dr. Hiss selected NEI’s 1981 diabetes retinopathy

study that showed that photocoagulation of periferative and pre-periferative retinopathy saved sight.

Unfortunately, the report was initially publicized 

primarily in ophthalmologic literature and meetings.

Subsequently as strong effort other health care professionals did not learn about it for about 3 years.

Now a strong effort has been made to have an annual

or biannual examination of a dilated pupil included

in standard diabetes care. However, in Michigan,

which Dr. Hiss believes is typical of the rest of the

United States, 40 percent of patients with diabetes

have never had this examination—21 years after the

science was reported.

An example of what the DRTCs’ translation components have accomplished collaboratively is the 1993

publication “Metabolic Control Matters,” a nationwide translation analysis and recommendations

based on the Diabetes Control and Complications

Trial (DCCT). The report included recommendations

for diabetes care from the DCCT, strategies and models for translation, and implications of the DCCT

findings on the structure of the health care system.

It also covered professional practice and training,

implications of the DCCT for patient education and

for social systems, and financing issues of intensified

management of diabetes. In 1995, the six DRTCs provided an updated report on the recommendations.

Based on the DRTCs’ 25 years of experience,

Dr. Hiss offered a definition of translation. He echoed

Dr. Spiegel’s comments that translation is not a onetime event; it is a sequence of many events divided

into two distinct phases. Phase I is the development

(from the bench) and application (to the bedside) of

new biomedical science to patient care. This is the

clinical research or bench-to-bedside phase, the “R”

in DRTC. Phase II is the application of new clinical

science through clinical trials, the product of phase I,

to community care. This second phase—the “T” role

of the DRTC—involves the identification and overcoming of barriers to widespread adoption of the

improved practices. Dr. Hiss stressed that these

phases are different, essential, and sequential and

performed differently by different people, who must

remain in touch with each other to resolve their

problems if we are to realize the social value of new

biomedical science. Phase I benefits several hundreds

of patients. Phase II benefits millions of patients.

Discussion. In the discussion following his presentation, Dr. Hiss described how attitudes towrad obesity

serve as a barrier to better diabetes care because 

of the perception that the patient’s weight is his/her

own fault. Obese persons are seen as failures by their

families and society in general, and thus obese patients with diabetes may receive less attention in the

health care system and also may avoid the health

care system because of their fear of being blamed 

or stigmatized.

It was suggested that translation and translation

research are not identical. In addition to the phase I

research, research can be done in phase II by studying how to foster the application of phase I research.

Dr. Hiss agreed that there is an enormous amount 

of translation research that needs to be done in

phase II.

Experimental Design Elements of Translation

Dr. Lawrence Green, Director of the Office of Extramural Prevention Research, CDC, gave two statements from a recent National Cancer Institute (NCI)

conference on dissemination research to frame his

presentation. The first quotation was “An ounce of

prevention takes a ton of office system change”

(Thomas Kottke). This relates to the need to bring

research methods to bear that allow for working with

complex systems. The second was about the culture

of the research community itself. One of the cultural

aspects of researchers is their conditioned concern

about having their best ideas stolen. The second quotation was “Don’t worry about people stealing your

ideas. If you have a really good idea, you will have to

cram it down their throats.”

DMICC ANNUAL REPORT 115 FY 2002
DMICC ANNUAL REPORT 116 FY 2002

Because of the increased potential to address diabetes at the primary level, as well the secondary 

and tertiary levels, Dr. Green said he planned to go

beyond the bedside in his presentation to examine

the community population-based considerations that

influence reaching the millions, both patients and

those not yet patients, who deserve the health care

system’s attention. First, he presented five ideal elements of experimental design as aspired to by

researchers in randomized clinical/controlled trials

(RCTs). He considered only one element—one or

more posttests to measure effects after the experimental intervention—as essential. The others are

ways to control threats to internal and external

validity. He feels that preoccupation with maximizing internal validity—threats to the validity of the

conclusions about the causal effect of the intervention—has neglected external validation. Thus a lot 

of research is less than convincing to practitioners

because it does not relate to their situation.

Dr. Green said he did not come “to bury experimental

design, but to praise it.” There are problems in

applying “best practices” from RCTs because of the

inability to achieve their controls in translation to

the community. Better use needs to be made of other

evidence beyond the clinical setting where there is

such strict control. Other problems include generalizing from one population, place, or circumstances to

another. Although there is a high degree of generalizability across the human species, because of its relative homogeneity, physiologically and pathologically,

in social groups, there is heterogeneity. This makes

generalization from one study setting or population

to others increasingly difficult as one moves up the

biopsychosocial spectrum.

Practitioners face three problems (identified by Brick

Lancaster) in translation that cause them to question

the high standards suggested by “best practices”

based on research conducted elsewhere:

• Accessibility gap: Do I have the same resources as

the experimenters had?

• Credibility gap: How different is their practice 

situation (i.e., university or large hospital setting

with grant money) from mine?

• Expectations gap: Do I need to strive for such lofty

goals in my practice?

Dr. Green noted that CDC has named 10 areas of

great public health achievements in the 20th century.

In the last third of the century, the smoking problem

accumulated in the first two-thirds of the century

was reduced by 50 percent. Similar public health

success was achieved in stroke and cardiovascular

disease deaths and in automobile crash-related

deaths, especially alcohol-related crashes. Dr. Green

described the various economic, social, regulatory,

and historical events affecting the changes related 

to cigarette consumption. Strong influences on the

decline in smoking included the Surgeon General’s

Reports on the hazards of smoking, the nonsmokers’

rights movements, the ban on broadcast advertising

and Federal tax increases, the development of 

over-the-counter cessation aids, and the master

tobacco settlement.

Lessons learned from the smoking cessation 

achievement include:

• Surveillance data systems are needed to track 

population trends, to establish baseline and trend

lines, put an issue on the public policy agenda,

show change, and compare progress. The Behavioral Risk Factor Survey System maps showing the

growth in the prevalence of obesity from 1985 to

1999 are an excellent example. They clearly indicate the growing epidemic in obesity over time and

across jurisdictions. Dr. Green said we are more

fortunate than smaller countries to have a 50-State

laboratory with variations in policies and programs to compare treatment across jurisdictions

and populations.
DMICC ANNUAL REPORT 117 FY 2002

• Comprehensive programs using a combination 

of methods are more effective than individual

methods; the more components, the greater the

effectiveness and the better the coverage. In tobacco control programs, only tax increases could

stand alone as an essential component. Successful 

components included community, statewide,

chronic disease, cessation, and school programs;

enforcement; surveillance and evaluation; countermarketing; and administration and management.

Dr. Green suggested that these same components

apply to diabetes.

• The ecological imperative means that a problem

must be addressed at all levels—individual, organizational, institutional, community, State and regional, national and international—and these levels

must be mutually supportive and complementary.

• There is a level of threshold spending below which

there is little effect. A critical mass of personal

exposure is needed to influence individuals and a

critical mass of population exposure is needed to

effect community response. To reach the less motivated, a critical distribution of exposure is needed.

Dr. Green said the RE-AIM model demonstrates

this well. Reach is a critical component of the

effect of a program. In smoking, anything below 

$2 per capita achieved little effect. Local ordinances are another critical component.

• The environmental imperative addresses the

opportunities, cues, and choices provided by the

environment, the social reinforcement of positive

behaviors and punishment of negative ones, and

legal penalties and financial incentives. These 

create new social norms. Dr. Green reminded the

group of how in the past the current room would

have been heavy with smoke.

• The educational imperative includes public awareness of the risks and benefits, interest in lifestyle

options, understanding of behavioral steps, attitudes toward options and steps, outrage at conditions putting them at risk, and personal and 

political actions. An informed electorate is necessary to get changes in public policy and legislation.

• The evidence-based imperative is the need to

bridge best practices from research to application

in practice. This means reaching the underserved,

special populations, the less affluent, the less 

educated, and the community-centered practitioners. Most research occurs amongst highly motivated persons and off-the-shelf protocols do not

translate well to other populations. Practitioners

and health care systems need the tools of research

to do their own immediate evaluation.

According to Dr. Green, viable alternatives to the

strict RCT-based interpretations, the gold standard

that has driven most “best practices” manuals,

are beginning to gain increased credibility with

practitioners. While the RCTs provide a valuable

foundation, there is no single best practice that is

appropriate for all patients and practitioners, or

even for some of them all the time, as they go beyond

the bedside. Behavior is influenced by a combination

of forces—predisposition, enabling, and reinforcement. Paying attention to all three is necessary for

sustained change, even with highly motivated 

persons, who, without support and reinforcement,

can become frustrated and rationalize away the

credibility of the source of the motivation. Different

sources of evidence need to build on the initial

structure and provide a menu of appropriate possibilities for different patients and populations.
DMICC ANNUAL REPORT 118 FY 2002

Dr. Green recommended that the intervention-based

research and planning habit be broken. This habit

has grown out of the pharmaceutical model of testing specific drugs as interventions by assessing the

response, increasing the dose to get a response,

and evaluating the response. This tends to increase

resource costs without necessarily ensuring they are

the appropriate resources for the population being

studied. The alternative is a population-based diagnostic planning approach in which the needs and

capacities of the population are assessed and a program is designed and implemented based on these

and a set of priorities and objectives. The program 

is then evaluated through a short-loop feedback

process to reassess the assumptions, and the program is redesigned. The short-loop cycle becomes a

management tool to improve performance in particular settings with specific populations. This approach

uses evidence from the community or population;

from behavioral, economic, and social research in

addition to epidemiological and medical research to

help assess causes of behavior and social change;

from experimental studies and research and development; and from evaluations in other settings similar

to the intended study.

Discussion. Dr. Hiss strongly supported Dr. Green’s

statement that translational efforts must be very

specific to the target audience, the setting, and the

situation. As an example, he pointed out that a translational effort with a 35-year-old primary care physician 4 years out of school working in a large hospital

that has an active internal medicine residency with a

large number of subspecialists in a large community

is very different than that effort with a 58-year-old

general internist who has been out of school for 25

years working basically alone in a small community

hospital with few subspecialists and no in-house

educational program.

Asked how the approach would be different, Dr.

Green responded that in the hospital setting with 

an in-house educational program, one works with

the house officer and builds into the training the

changes in care with this captive audience and 

this works back through the attendees.

In response to a question as to what approach

should be used in what situation to direct the 

translation, Dr. Leonard Pogach, Veterans Administration (VA), commented that it is the system of 

care that drives the approach. In the VA system 

there are a variety of types of hospitals, rural and

academic, that are guided by a system of care with

integrated electronic medical records, nationally

promulgated evidence-based guidelines, quality

improvement efforts, and performance measures 

that drive the system.

Dr. Spiegel pointed out that the obesity issue 

cannot be viewed solely from the provider perspective, because there are important environmental

influences. Although there is arguably a difference

between smoking and eating as addictive or nonaddictive behaviors, one does have to eat to live. He

recommended Food Politics, recently published by

Dr. Marion Nestle, head of the nutrition department

at New York University. He noted the parallels in

food and tobacco advertising to children and to

underprivileged minority groups. This action has relevance in advertising to children and to underprivileged minority groups. However, rather than smoking

cessation as an example for translation research 

for diabetes, Dr. Spiegel prefers the example of the

decline in cardiovascular mortality. He asked if this

decline indicated a public health success in reducing

cardiovascular disease or are individuals developing

congestive heart failure in larger numbers or other

outcomes that are more lingering. Dr. Spiegel posed

two related questions. Does the decline reflect control of blood pressure, control of cholesterol, and

changes in diet and exercise? If so, then why do we

have this increased obesity epidemic over the past

two decades?
DMICC ANNUAL REPORT 119 FY 2002

Dr. Green responded that tobacco cessation was the

effort he knew best and it had contributed to the

cardiovascular success, but obviously had run in the

opposite direction from the obesity problem. The

cardiovascular effort was much more complicated.

Dr. Denise Simons-Morton, NHLBI, answered that 

it was true that along with decline in mortality,

there have been dramatic increases in heart failure.

Over the years, improvements in quality of care 

has resulted in improvements in all the risk factors,

except obesity, in spite of improvements in diet,

in smoking, and some in activity and treatment

improvements in blood pressure and cholesterol.

There has been a positive impact on cardiovascular

disease (CVD) mortality, but there is still a problem

in CVD with obesity and the burgeoning diabetes

epidemic, an important risk factor for CVD. There

remains the relevant issue of competing risks: if 

people live longer, then what will they develop.

Dr. Garfield mentioned that the initial presentations

and discussions had described barriers to translation. The later discussions would address how to

revise translation research to combat those barriers.

Translation Research at the University of Chicago

DRTC

Dr. Marshall Chin, Associate Professor of Medicine,

University of Chicago, discussed the importance of

collaborative community-academic-government partnerships in diabetes translational research, especially to improve care in vulnerable or hard-to-reach

populations. He offered the Public Health Service’s

Community Health Centers (CHCs) and the MidWest

Clinicians’ Network (MWCN) of CHCs as examples

and as a basis for later discussion on what types of

translation research might be funded by NIH and 

the other DMICC agencies, many of whom are key

partners in the current efforts. He stated that community-based participatory research has come to 

the forefront in the efforts to find innovative ways 

to reduce racial and social-economic disparities in

health care and outcomes.

CHCs were created by Public Health Service Acts

329, 330, and 340 to provide a broad community

health perspective, serve the medically underserved,

and focus on community participation. In 1995,

MWCN chose diabetes as their number one priority

for improvement and established a 55-member

research network with pilot funding from the Agency

for Healthcare Research and Quality (AHRQ) and the

Bureau of Primary Health Care (BPHC). The mission

was to conduct credible, meaningful research on

health care access and delivery issues in special

populations served by CHCs. In 1997, MWCN sought

an academic partner through NIDDK, and the University of Chicago became that partner in the research

group along with BPHC.

Reviewing CHC performance against the American

Diabetes Association’s (ADA’s) quality of care guidelines, the committee determined in its first study

that improving quality care meant achieving the difficult goals of critical self-examination, courage to

adopt new ideas, and rigorous evaluation of interventions. The second study was a needs assessment

at the CHCs to determine barriers and produced

three major findings: Physicians wanted help in

facilitating behavior change in patients, wanted

improved efficiency in the CHC, and wanted macro

health policy issues (insurance, access) addressed.

At about this time, BPHC, CDC, NIDDK, and others

developed a three-prong diabetes breakthrough

series (BTS) that included continuous quality

improvement cycles, a chronic care model, and 

learning sessions to work collaboratively and 

share lessons learned.
DMICC ANNUAL REPORT 120 FY 2002

A study of 19 midwest CHC’s that applied the 

diabetes BTS showed improvement in key ADA recommendations of care such as eye and foot exams

and urine microalbumin testing, improvement in A1c

levels, and enthusiastic support for the intervention.

In interviews, physicians noted several issues that

impacted their ability to improve standards of care

in the community and that are relevant to translation: They needed more time and resources to provide the intervention, paper registries needed to be

converted to electronic recording, and lack of senior

leadership and support and staff turnover were

problems. Another major concern was how to sustain

gains after the first year. In response to these studies, Dr. Chin listed current intervention efforts of the

group including an RCT-based study of the BTS

intervention, provider training in behavioral change,

patient empowerment, and hypertension and lipid

projects. One evaluation technique was audio tapes

of patient-doctor encounters to assess if patients

asked questions based on the ADA standards.

As an example of some of the diabetes translation

questions and issues at the CHCs, Dr. Chin next

described evaluation of a BPHC-sponsored 6-year

initiative to improve chronic care in CHCs, with an

emphasis on diabetes. The evaluation was based on 

a conceptual model of a health disparities collaborative that was assessed at two sites, Chicago DRTC

being one them. Incentives and assistance flowing

between BPHC, the CHC leadership, and the CHC collaborative team, providers, and staff are key components of the model. Organizational and environmental characteristics are recognized as affecting the

next level of the model, the improved organizational

structures and processes, which then impact the

clinical processes of care and patient outcomes, the

sustainability and distribution of the interventions,

and the costs.

The evaluation of the health disparities collaborative

model had three aims: (1) to determine if the model

improved health care quality and outcomes; (2) to

determine if it enhanced effectiveness, sustainability,

and spread by providing understanding and improving incentives and assistance for leaders and staff;

and (3) to evaluate costs and cost-effectiveness. Dr.

Chin said the second aim might be the most important in providing answers to the translation challenge of how to get something to work in the real

world over time.

Dr. Chin characterized diabetes translation research

issues as being diverse and complicated, involving

quality of care, outcomes, access, and costs across

the multiple intervention levels of patients, including

children and older persons, providers, centers, and

health care systems. They require multiple methods

from multidisciplines. Methodological resources

include biostatistics, economic analysis, and database management, along with a large variety of

research areas. From the funding agency perspective,

a major challenge is how to evaluate proposals and

encourage innovative, creative research that takes

advantage of multidisplinary approaches.

In summary, Dr. Chin named the following three

issues faced by community-based participatory

research: 

• Developing and funding relationships of trust 

and equality that recognize the partners’ different

goals, needs, and skills and accepting that building

such relationships takes time.

• Dealing with the time constraints and need for

flexibility required by the real world and recognizing which partners are ready to change.

• Promoting a common vision across the partners’

agendas and obtaining senior leadership’s buy-in.
DMICC ANNUAL REPORT 121 FY 2002

Discussion. Since not all standards are equally 

evidence-based and those that are can vary by populations, especially by age, the question was asked

whether there was a need to prioritize delivery of

services within constrained systems and related

costs, and if so, how should they be prioritized. Dr.

Chin responded that there is a lot that needs to be

done in several areas at this time. A primary determining issue currently is what is practical. In CVD

and diabetes management, Dr. Chin sees hypertension control as being easier to work on than glucose

control. As progress is made, there may be more 

of a role for prioritization. CMS, for example, is 

considering whether outpatient quality indicators

for the Medicare population should vary by age. In

diabetes risk factors, should some areas require

more attention than others. Dr. Chin said, possibly,

but on the other hand, there is so much room to

grow that group autonomy needs to be respected.

Groups may have different priorities for very good

reasons, so it may not make sense to apply the same

standards in the VA and the health centers and the

Medicare population. Some may overlap and some

may be different.

Dr. Russell Glasgow, Kaiser Permanente AMC Cancer

Research Center in Colorado, raised the point that

there is considerable variability in success across

the centers in applying the BTS approach. Dr. Chin

agreed and attributed this to issues of leadership

and culture, although on the whole all are enthusiastic and idealistic groups. He emphasized that the

CEO or the medical director is crucial to supporting

the changes needed in the organization and in making the sustainability of the approach a strategic 

|priority and to ensure incentives are developed to

combat burnout over time.

Dr. David Stevens, Health Resources and Services

Administration (HRSA), commented that translation

involves system change, not just removal of barriers.

He noted that three main tools have been effective 

so far in promoting system change. One of these is

moving from an acute care model to a multi-element

chronic care model, that is population-based as well

as patient-based. The assumption is that one cannot

change or improve a system by maximizing only one

element, as was illustrated by the tobacco interventions. Teams need to work on all the elements simultaneously to make changes. A second tool is an

improvement model that relates to taking a general

idea proven in research and applying it in various

settings. The model provides measures acceptable 

to the research field to test the idea in the settings.

The third tool is the learning model that allows for

learning and changing over time, such as a year,

rather than attending one or two CME courses.

Dr. Chin stated that placement of the focus depends

to some extent on the individual organization. For

example, for the individual practitioner or health

care organization, the system is where one must get

the most result from their investment. An agency

such as NIDDK can take a broader viewpoint.

Translation Research: Insights from

Cardiovascular Research

Dr. Harlan Krumholz, Professor of Medicine and

Epidemiology, Yale University School of Medicine,

said that those who are interested in diabetes are a

special community of people who focus on a large

population in the country, are concerned with the

acute stages in diabetes care, and then follow up

with efforts to manage the chronic nature of the 

disease. In carrying out their mission, they are used

to working in multidisciplinary teams and thinking

about a populations’ health and about individual

patient care decisions from initial diagnosis through

the patient’s lifetime. There is so much that researchers and providers need to know to inform the
DMICC ANNUAL REPORT 122 FY 2002

way to bring about change. He stressed that as 

NIH’s budget is increased and applied to support

discovery, the application side needs equal enthusiasm. Dr. Krumholz gave two examples of how little 

is known about promoting behavior change. It is not

clearly understood why there is a stigmatism of bad

health behaviors amongst health professionals, but

this change was not because of legislation, or adaptation of quality measures, or educational sessions.

Likewise, dress fads sweep the country, especially

amongst teenagers, but there is no understanding 

or documentation on how this happens.

Dr. Krumholz asked “What is the paradigm?” The conventional paradigm is that great discoveries happen,

research is conducted to demonstrate that something

should be done, and then the discovery is applied.

This is rarely a linear process. It goes backwards

and forwards. There are also terminology issues—

translation research, translational research, differences between type 1 and type 2 translation

research, outcomes research, and so forth. He defined

outcomes research as “applied clinical research that

generates knowledge to improve clinical decisionmaking and health care delivery to optimize patient

outcomes.” This research has a broad focus related to

providing evidence applicable to enhancing and promoting quality patient care and population health.

It strives to understand factors and consequences of

patterns of care and to develop strategies to address

current deficiencies and knowledge. Outcomes

research is about questions, not methods, and takes

advantage of observational, quasi-experimental, and

clinical trial approaches to address the challenges

and do timely, relevant research. He stressed the

necessity of embracing a broad range of approaches

in a variety of areas and in moving to develop models to gather information quickly, process and evaluate an intervention, and get it to the public, and then

evaluate its effect on the next generation. This will

require thought and a change in the paradigm of

what constitutes good research. The traditional 

journals do not always appreciate such real world

approaches because they do not fit easily into a 

current paradigm.

Applying public health discoveries will always present challenges. It is thus important to study and

develop an infrastructure to do this translation. Dr.

Krumholz stated one goal is to have evidence-based

health policy, acknowledging that there will never 

be absolute evidence of the right thing to do. A second goal is appropriate adoption of innovation.

Surveillance, knowledge of what is taking place, is

important to this goal. Finally, rigorous evaluation 

of changing practices at the community and clinical

level is a necessary aim to understand the implications of the process changes being made. He cited

the example of the change in hospital stay for bypass patients from 10 days to 4 days, without any

requirement for monitoring the effect of this earlier

dismissal, unlike the stringent requirements on prescription drug usage. Domains to be considered

include safety, effectiveness, efficiency, equity or

access, patient-centeredness, and timeliness.

The good news/bad news, according to Dr. Krumholz,

is that there is great progress in diabetes but not as

great as it could have been, advances in knowledge

along with substantial gaps in applied science, and a

focus on discovery with a relative neglect of application research. He recommended that NIH take the

lead in showing Congress and the public the value of

not only research to find a cure for cancer, for example, but research to find a way to better apply the

cure. This will draw the best people to the field, identify the best problems, and obtain the best answers.

The age-adjusted incidence of CVD has dropped dramatically for a variety of reasons, including health

care changes and secular changes. However, prevalence of CVD cases is expected to explode because of

the epidemics in diabetes and obesity and the aging

of the population. The issue is not just mortality or

years of life, but morbidity, quality of life.
DMICC ANNUAL REPORT 123 FY 2002

Applying discoveries is not as simple as “just do it.”

Variations in population characteristics and settings

affects the generalizability and validity of an intervention as well as changes that take place between

the time of the initial discovery and study and the

present day. Besides the cost of the intervention,

there is usually a question of just what part or strategy of the intervention actually caused the positive

result. Dr. Krumholz gave the use of beta-blockers

after an acute myocardial infarction event as an

example of these translation challenges. Following

the NIHLBI-funded trials in 1981, guidelines were

issued with a number of contra-indications, and

basically it was left up to physicians what to do,

with no surveillance of practices for a long time.

Then in the 1990s, a few studies showed that less

than half of those who were ideal candidates for the

beta-blockers were receiving them. Further studies

showed that in 1995, this was still true. Questions

were also raised about effectiveness, so observational studies were done with the elderly and with diabetics. Finally, additional application issues have

been raised. What are the key success factors to

adopting this? How can we do studies to enhance

this approach? Currently, about 75 percent of prime

candidates are being treated.

Other trials have been conducted in management 

of heart failure, lipid management, and the role of

diet in CVD. In general, each disease management

intervention has shown approximately a 50 percent

reduction in readmission rates. A major issue is who

will pay for an intervention that may actually reduce

the health care system’s revenue stream. Therefore, a

number of potentially valuable applications are not

being used in practice or being evaluated for effectiveness. With regard to diet, there is not a clear definition of what the right diet is. Billions are spent on

diets, but the knowledge of what works for whom is

not being collected. If known, there would remain

the question of how to get people to do it.

Effectiveness involves both efficacy and knowledge

of what in the setting, the population, the intervention, or the administration of the intervention is

working or not working, during the trial and beyond

in the community practice. Dr. Krumholz cited reperfusion therapy as an example. There were many trials, but few studies on the right way to organize the

hospital in order to administer the medication and

successfully replicate the trial results. He suggested

that such studies would result in more “bang for the

buck” from funding these trials. Hypertension has

similar issues. Treatment efficacy studies compare

drugs that the pharmaceutical industry chooses to

compare, which leaves providers confused about

which are the most efficient strategies. Also, there

are few studies on the most efficient way to screen.

Should everyone have a blood pressure measure by

age 45? Screening and identification strategies do 

not have the attention that treatment does. In addition, measurements in a trial are administered 

much differently than they are in a doctor’s office.

In other words, there is a whole range of questions

and issues that are downstream from the original

discovery or knowledge.

Dr. Krumholz listed several issues of particular significance to him. These included decision making

based on the patient’s characteristics and preferences and the complex world in which the person

lives. Should we assume that everyone wants to 

minimize risk regardless of the level of their risk 

and their circumstances? He quoted Dr. Feinstein’s

statement that “clinical judgment depends not on a

knowledge of causes, mechanisms, or names for disease, but on a knowledge of patients.” He noted that

the quality of the research spanned a large spectrum. He asked that NIH recognize that implications

for the field include external perceptions, training

needs, and enhanced funding opportunities.
DMICC ANNUAL REPORT 124 FY 2002

In the hierarchy of research, RCTs, according to Dr.

Krumholz, are not necessarily the best way to answer

questions. It depends on whether the question is 

one of comparing direct medical treatment procedures or one regarding effective care in general, for

example. The first calls for an RCT, the second for a

real-world observational study. He urged that existing data, even if it is still debatable, be made available more rapidly, citing the 7-year delay since the

Framingham study. Partnerships with agencies and

quick grant mechanisms are needed to take advantage of the data sets already collected. He also recommended that although industry has contributed

much to research, NIH should look at opportunities

and challenges that industry is not interested in,

ones that are important to patients even though 

not profit-making.

In summary, Dr. Krumholz presented a set of 

perspectives or needs. These included:

• Directing resources toward application and 

surveillance as a complement to the investment 

in discovery.

• Training future clinical investigators.

• Using multidisciplinary approaches.

• Forging public policy links.

• Making improved health a paramount goal.

• Gaining insight into enhancing translation of 

the best science.

• Continuously evaluating and refining the definition

of best science as applied in the real world.

• Relying on parallel efforts, not perfect science,

for appropriate evidence to implement practices 

in the community.

Discussion. It was observed that a large part of 

NIH efforts seems to be based on a model that 

there will be a breakthrough that will lead to a cure.

Although there has been some modification of this,

this is still the driving force. In CVD and stroke, the

age-adjusted death rates have declined 70 percent

without understanding all the genetics underlying

the disease risk. There is likely to be a breakthrough

in type 1 diabetes, but in type 2 diabetes, due to its

being intricately intertwined with obesity and metabolism and environmental influences, the benefit

may be incremental and dependent on studies about

how to do things in the real world.

Dr. Spiegel added that an intriguing scenario in type

2 diabetes is when the University of Pennsylvania’s

Dr. Mitchell Lazar discovered that insulin resistance

is possibly affected by a secreted hormone coming

from fat from an endocrine organ. It was thought

that perhaps a pill, not lifestyle, could uncouple

being fat from insulin resistance. If so, then there

might be obesity, but not type 2 diabetes. He noted

that it is interesting to contemplate if that would 

be a good thing.

Regarding using case studies to promulgate information, Dr. Pogach said that the VA did a gap analysis

and performance measures and learned that heart

patients were not getting the proper education, or 

at least it was not documented. The VA implemented

a performance measurement mandating the delivery

of the information, developed health tip tools for

patients and templates for providers, and sampled

the 140 facilities over several months. Improvement

varied between 20 and 100 percent. The agency has

researched rigorous tools to reevaluate risk-adjusted

readmission rates for heart failure nationwide using

administrative data sets. Now the group is prepared

to conduct observational studies. Dr. Pogach agreed

that perhaps it is now time to get the information

out more quickly, recognizing that there is a role for

case studies as well as observational studies and

well-conducted health services research.
DMICC ANNUAL REPORT 125 FY 2002

Dr. Krumholz agreed that such publication is important, along with rigorous collection of data to accompany the intervention and rigorous, systematic 

evaluation of exact impacts. It is important to be

able to trust the data.

Diabetes Translation Research: The Next 25 Years

Dr. Russell Glasgow, Senior Scientist at the Kaiser

Permanente AMC Cancer Research Center in

Colorado, opened his presentation by quoting Yogi

Berra who said “In theory, there is no difference

between theory and practice. In practice, there is.”

In looking at the next 25 years for diabetes translation research, he reviewed the key accomplishments

and lessons learned from the initial 25 years, discussed needed changes based on the RE-AIM model

and recommended responsive new approaches, and

identified key areas and opportunities for future

translation focus.

In looking back, Dr. Glasgow noted there has been

almost a paradigm shift in diabetes management 

to a patient-centered focus that did not exist as late

as 10 years ago. There have also been guidelines 

and systems change interventions that share such

commonalities as having nurses do diabetes care

management; using proactive, planned, populationbased interventions; and recognition that the fault 

is not the patient’s or the provider’s, it is a systems

issue. It has been shown that practical behavioral

and office-based interventions do bring about 

effective change.

Dr. Glasgow cited successful robust, replicable 

interventions across populations and settings and

programs to reduce health disparities that have 

provided valuable lessons in spreading and generalizing knowledge. For the latter, he referred particularly to the Diabetes Prevention Program (DPP),

the CHC partnerships, the VA and the Indian Health

Service, and the National Diabetes Education 

Program. He emphasized that diabetes and its 

management are extremely complex. Accompanying

the many attributes of self-management are the

impact of individual, social, and environmental 

variables. A person may do well in one self-management area and less well or poorly in others. The 

relationship of the variables and performance to 

outcomes is also complicated.

Using aspects of the chronic care model and the 

RE-AIM model, Dr. Glasgow listed changes that 

need to take place. These included:

• (R)Reach: expand the focus on creating and 

documenting broadly applicable interventions for

diverse populations and persons with comorbid

conditions (who are usually excluded from studies,

even though most diabetes patients have multiple

chronic problems). Dr. Glasgow noted that designing a perfect intervention does not mean people

will choose to use it.

• (E)Effectiveness: broaden the outcomes so they

are more sophisticated and comprehensive; include

economic outcomes and quality adjusted life years

(QALYs) from the patient’s perspective.

• (A)Adoption: pay more attention to settings and

agents, particularly to learn who can most effectively deliver the program.
DMICC ANNUAL REPORT 126 FY 2002

• (I)Implementation: pay more attention to issues

such as what level of intervention can non-professionals implement, the consistency of the intervention as a variable, and the error in concluding that

the intervention was not successful when, in fact,

it was never truly delivered. Accurate delivery of a

research discovery is a challenge in the real world.

• (M)Maintenance: pay more attention to social/-

environmental factors influencing maintenance,

conduct long-term followup studies of participants

and settings, and better understand the effects 

of policies and the interaction of policies and

behavioral treatment.

Dr. Glasgow prefaced his recommendations for

future translation research by quoting Einstein’s

statement that “The significant problems we face

cannot be solved by the same level of thinking that

created them.” It is necessary to “think out of the

box.” Future interventions need to reach those who

can most benefit, be adaptable to different settings,

be implemented consistently by staff with moderate

levels of training and expertise, and produce replicable, long-lasting effects with minimal negative

impacts and at a reasonable cost. Dr. Glasgow said

there needs to be a cultural change on the part of 

all relevant parties, not just researchers, but funding

agencies, reviewers, and policymakers. He then listed

specific recommendations for each of these groups.

Researchers need to reach large, representative 

populations, especially the underserved. They also

need to report on implementation and outcomes

across a range of interventions, agents, and settings.

Funding agencies should support studies in multiple

settings representative of real world practice and

report both mediator and moderator effects. They

should fund innovative ways to enhance reach, adoption, implementation, and maintenance and require

and fund a maintenance/sustainability phase. There

should be standardized reporting of exclusions, participation rates, and representativeness of participants and settings.

Reviewers need to undo bias and old learning,

provide greater balance in looking at internal and

external validity, relax criteria on long-term maintenance, and include the potential for translation as 

a standard, as has been done with innovativeness.

In policymaking, it is time to “put our policies and

money where our mouth is.” Rather than talking

about the importance of translation and patientcenteredness and other issues, we should include

behavioral counseling indices in performance 

measures and provide incentives for individuals 

and systems.

Dr. Glasgow stated that there are incredible opportunities at this crossroads in translation research.

Key areas for future diabetes translation research

include:

• Comprehensive evaluations of interventions that

address social context, noting that “things are not

always what they appear.”

• Genetic and behavioral issue interfaces, especially

gene-environment interactions and the future of

genetic counseling, shared decisionmaking, and

risk perception science.

• Prevention issues learned from DPP, including

cost-effectiveness and less-motivated populations.

• Integrated technology applications to facilitate and

support patient/provider interactions and enhance

reach, implementation, and maintenance.

• Health care systems change, including policy 

factors that impact systems.

Proponents of the chronic care model believe

changes are needed in all components of the model

in order to see lasting, significant change. The 

ultimate goal is to see productive interactions

between a prepared, proactive practice team and 

an informed, activated patient. For the future, the

impact of policy and the social environment also

needs to be evaluated.
DMICC ANNUAL REPORT 127 FY 2002

Dr. Glasgow offered an exercise looking at a future

discovery of an amazing weight-loss intervention to

deal with the obesity issue on a population basis.

If an unprecedented 40 percent of the clinics adopted the intervention in their setting and 40 percent of

the agents adopted it, the overall effect on the population would be only 16 percent. If a phenomenal 

40 percent of the patients who tried the intervention

were successful, the population effect would still

drop to 6 percent. Including the factors of consistent

delivery, behavior change, and sustainability, the

cumulative effect would fall to less than half of 1

percent. The good news is that with greater attention

to these factors, there can be a greater public health

impact and perspective.

Dr. Glasgow said that if we are serious about seeing

greater translation change, then we must require

fundamental improvement and change in the culture

at all levels of participation. The stepped care pyramid model illustrates this. To date, the largest

amount of research has been at the top of the pyramid at the level of a very small segment of people,

some at the primary care and health care systems

levels, but relatively little at the community/neighborhood, media, and policy levels at the base of the

pyramid. Whereas reach is highest at the lower levels, intensity and cost are highest at the upper level.

Dr. Glasgow suggested that it might be more costeffective and efficient to do more interventions at 

the lower levels for everyone.

In conclusion, Dr. Glasgow recommended, “the best

way to predict the future is to create it” but to keep

in mind that as H.L. Mencken said, “to every complex

question, there is a simple answer—and it is wrong.”

Discussion. Dr. Green identified that one thread 

running through the presentations and discussions

was the degree to which those present really believe,

as one moves out beyond the bedside, that there are

interventions that can be packaged and made generalizable. The attendees fall along a continuum with

respect to this thread. He said he took the position

that no off-the-shelf, generalizable interventions

exist. Interventions must vary with the person and

the circumstances. However, RE-AIM seems to 

imply that there is something concrete, specifiable,

exportable, and generalizable. He asked if Dr.

Glasgow would be revising the RE-AIM model.

Dr. Glasgow replied that what we should learn from

research, if it is cumulative, is some generalizable

principles, not just theories or hypotheses, and this

result can be enhanced by studying mediators and

moderators. There are some common principles in

self-management education that apply across settings, such as collaborative goal setting, followup,

or integrating self-management into primary care.

Dr. Glasgow did agree that one cannot take an intervention, even one as successful as DPP, off the shelf

and apply it exactly the same. It must be tailored 

to the setting, working with partners to apply the

principles of the intervention in the setting.

Dr. Stevens asked that in order to have a concept

implemented or replicated, does it not have to be

specific and not so generalizable that it is “messy”

to apply. Dr. Glasgow said that the level of specificity

is a good challenge. Most people cannot take the

general principle, such as collaborative goal setting,

and do it. Everyone thinks they do that, but actually

few really do it in a way that is patient-centered.

People need options, concrete examples, and tools in

order to not have to reinvent the wheel. By being creative and willing to try things, centers have taken

the principles of goal setting and having an action

plan from the study setting and made them work in

their settings. They have taken ideas and examples

from academic researchers and adapted them to a

lower literate, even almost illiterate level, to be used

as tools for interventions.
DMICC ANNUAL REPORT 128 FY 2002

Dr. Glasgow was asked if he would recommend the

use of QALYs to set areas of priorities for interventions, and if so, what would be the implications 

for DMICC. Dr. Glasgow said one clear implication

was that number one on the list would be redoubling

efforts for smoking cessation for anyone with diabetes who smokes. That would be the single most

cost-effective intervention, and there is a lot of 

information on how to produce system change in

smoking. The questioner agreed and said that blood

pressure would probably be second. Dr. Glasgow

concurred and addded that one of the important 

lessons learned is that diabetes is about more than

just Alc, although we must continue to improve our

efforts to control that while broadening our focus.

Afternoon Presentations and Discussions

Dr. Saul Malozowski, who has been appointed as 

the new DMICC Executive Secretary, announced that

the afternoon’s format would vary from that of previous meetings. Rather than agency representatives

providing a position statement and update of their

current and proposed activities in relation to the

meeting’s subject, they would be discussing a set 

of questions posed by the speakers about emerging

issues in diabetes translation research and implementation. The exception would be a presentation 

by Dr. Desmond Williams, Centers for Disease

Control and Prevention (CDC).

Desmond Williams, MD, PhD, Division of Diabetes

Translation, CDC

Dr. Williams began by stating that many people at

CDC have been working to learn new techniques 

and strategies to address the complex issues of diabetes research translation. CDC views translational

research as a way to identify and test strategies of

change aimed at achieving optimal diabetes care,

to assess the level and quality of care practices, to

explore factors affecting variations in care, and to

identify barriers and enablers of change.

Dr. Williams presented a CDC graphic depicting

translation research in the context of other models

of research, such as basic science/epidemiology, surveillance, and clinical trials, that are used together

to better characterize and understand problems and

track changes over time. CDC sponsors, conducts,

and participates in clinical trials to understand solutions to problems. There is an ongoing translational

process in which progress is made from one step to

another and much is learned from mistakes made.

Current translational efforts embody a variety of

approaches at different governmental levels. Translating Research Into Action for Diabetes (TRIAD) 

is a health system’s approach, Diabetes Control

Programs (DCPs) are administered by State health

departments, Diabetes Collaboratives take place at

the CHCs, Project DIRECT (Diabetes Interventions

Reaching and Educating Communities Together) is

another community-level effort, and the U.S.-Mexico

Border Study is an international project.

The CDC/NIDDK multi-center TRIAD study, funded

by a 5-year cooperative agreement, involves 11 plans

and 63 provider groups and 194,000 persons with

diabetes. The TRIAD centers are located in Hawaii,

Texas, Indiana, California, Michigan, and New

Jersey. The study uses baseline and longitudinal

analyses to investigate structural factors, processes

and quality of care, and health outcomes issues and

interactions. This ongoing study is expected to produce information on the status of diabetes care in

managed care organizations.

Levels of funding distinguish core and comprehensive nationwide DCPs, with cores receiving up 

to $240,000 and comprehensives, up to $800,000.

Although CDC-funded, the groups operate as autonomous bodies, so all have different activities of

concentration. CDC encourages the establishment

and maintenance of statewide diabetes coalitions

and each State has a Diabetes Advisory Committee.

Examples of activities include diabetes surveillance

and services, community-based programs to control

complications, and public and provider education.

The groups strive to identify barriers and enablers
DMICC ANNUAL REPORT 129 FY 2002

to changes in diabetes care and develop outreach

programs for minority populations.

Project DIRECT is the largest community-based 

diabetes project in the United States. It is an equal

partnership among CDC; the community of southeast

Raleigh, North Carolina; the Division of Public

Health in the North Carolina Department of Health

and Human Services; and North Carolina’s Wake

County Human Services. The community has developed a coalition, supported by the partners, that

guides intervention activities. The coalition-written

goals are to improve quality of care and self-management practices, detect undiagnosed patients and

ensure persons with diabetes are in the health care

system, and reduce risk factors by advocating and

encouraging lifestyle changes.

The 5-year U.S.-Mexico collaborative study will be

taking place in medically underserved communities

on both sides of the border. The study communities

have high poverty levels and many of the Hispanic

members are uninsured or underinsured. The project’s purpose is to determine the prevalence of diabetes along the border and to develop bi-national

prevention and control programs. Besides CDC,

international partners include the Pan American

Health Organization, the U.S.-Mexico Border Health

Association, the Secretaría de Salud de México, State

Health Authorities and DCPs, Paso del Norte Health

Foundation, El Paso Diabetes Association, the Border

Health Foundation, and the California Endowment/

Project Concern International.

Other CDC research activities used to support translation efforts include surveillance and evaluation

projects using both quantitative and qualitative

methods. Along with efforts to learn more about 

barriers and enablers, CDC is trying to find ways to

institutionalize activities in the community to make

them more self-sustaining. CDC is committed to and

actively engaged in translational research as a way

to reduce the burden of diabetes and its complications. The agency sees translation research as a 

necessary bridge between basic and clinical research

and diabetes care practices. It is an ongoing process

of developing, testing, and implementing new strategies. Dr. Williams said CDC believes it is important

to have opportunities like the DMICC meeting and

other forums in which to share experiences with

other agencies.

Discussion. Dr. Green spoke about the announcement of a new urban research center to be established in El Paso, funded by his office and the 

epidemiology program office. There are currently

three such centers engaged in participatory research.

Asked if the U.S.-Border Study was connected to 

this, Dr. Williams replied that it was a separate project. In response to the status of Project DIRECT, he

said a contract for evaluation had recently been

awarded and that CDC feels they have learned a

great deal from this project, including lessons

learned about collaboration. The evaluation will 

look at the study’s achievements, analyze methods

both qualitatively and quantitatively, look at differences in diagnosed and undiagnosed diabetes, and

examine other issues set up by the primary study

objectives. Important items to assess will be about

how was the community accessed, what were the 

initial problems and how were they resolved, what 

was learned from this, and what lessons can be

gained from the study to share with others. The

study is ongoing with final results expected in

approximately 3 years.

Emerging Issues in Diabetes Translation

Dr. Malozowski said that speakers had submitted

about 20 questions earlier. These thoughts were used

to form the following set of issues to be discussed by

the DMICC representatives:

• What is the most important translation issue for

your agency?

• What do you see as the unique role of your agency

related to diabetes translation and how do you

envision your agency responding to the outcome 

of today’s meeting?
DMICC ANNUAL REPORT 130 FY 2002

• What are the barriers to diabetes translation 

that your agency faces and what is the single most

important thing that can be done to accelerate the

translation of research to practice?

• At your agency level, what can be done to address

the challenges of diabetes translation involving: 

– patient and provider,

– health care organizations, and the

– health care system?

• At your agency level, what can be done to ensure

that there is the breadth of expertise needed to

develop, nurture, and evaluate diabetes translation

initiatives, such as: 

– health services research,

– behavioral research,

– organizational theory,

– epidemiology, and

– economics, etc.?

• How can your organization form collaborative

partnerships with other funding agencies, academic institutions, and community partners to work on

diabetes translation efforts?

Veterans Administration. Dr. Leonard Pogach

referred the audience to www.oqp.med.va.gov where

the VA’s performance measures are posted on the

Web. For diabetes care, the VA average nationwide 

is equal to or exceeds the 90th percentile of all

NCQA reporting plans. The VA embraces change in

translation at every level—systems, management,

and research—which is why they are successful,

according to Dr. Pogach, along with the Indian

Health Service and the U.S. Department of Health

and Human Services.

Dr. Pogach said that the VA’s primary translation

issue at this time concerns the nature of its patient

population, which is economically disadvantaged,

with 10 percent homeless and 30 to 40 percent 

with a mental health condition. Even with the mental health problems, their process measures and

intermediate outcome measures for diabetes are

comparable. With distal outcomes, mortality, amputations, and so forth, there are still disparities.

Understanding that is a challenge for the agency.

Another issue is that the VA cares for about 800,000

persons with diabetes, of whom 70 percent are Medicare eligible, with attendant policy-level considerations. The VA has a computerized system of medical

records, computerized reminders, outcome information, and nationwide automated data sets. This

enables him to have a research set of all diabetes

patients with their Medicare data, which offers

extraordinary opportunities to look at the delivery

of health care within their system.

Competing resources for the patients’ wide range of

health problems, such as stroke and mental health

conditions, can be a translation research barrier.

Hepatitis C affects about 12 percent of the population. The VA is also the Nation’s largest provider of

AIDS care. There is tension between quality improvement and research. There is also a lack of consensus

often as to what measures most need to be tightly

controlled in seniors—hypertension, hyperlipidemia,

or glycemia. Glycemia usually wins, which Dr.

Pogach disagrees with, and he challenged DMICC 

to send out a unified message that for seniors, while

not demeaning glycemic control, it is blood pressure

and smoking that should be the priorities in using

the health care systems’ limited time and resources.
DMICC ANNUAL REPORT 131 FY 2002

The VA has a Quality Enhancement Research

Initiative (QUERI), which is funded for eight or 

nine disease entities, of which diabetes is one.

The research coordinator is Dr. Rod Hayward at

Michigan. Dr. Pogach is the clinical director. There

was a Medicare supplement report on the initiative

in June 2000. The goal throughout the VA is to systemize the quality of care. To accomplish this, the

QUERI groups are integrated as much as possible

with operations, with efforts made to overcome

research/operations barriers as much as possible.

Both researchers and policymakers serve on the

executive committees for the QUERI groups. This

system helps to bring the efforts of the whole VA

health services community to bear on problems. In

addition, a number of QUERI investigators serve 

on the VA/DoD national guideline council that integrates guidelines and performance measurements

and implementation evaluations for both agencies.

In summary, Dr. Pogach said the VA has a unique

system of care that, although sometimes somewhat

bureaucratic and para-military and, like most of 

the other agencies, responsible to Congress, it does

embrace change and innovation.

Discussion. Dr. Speigel asked if the VA was considering primary prevention of diabetes. Dr. Pogach

answered that revisionary guidelines were coming

out that would incorporate the ADA position statement on screening as a consensus-based statement.

The VA population’s average age is 67 and even

among non-diabetics, there is 40 percent hypertension and hyperlipidemia is endemic, so the agency 

is looking for opportunistic screening in the population. Primary prevention has not been addressed

directly, just implicitly. Because of the Institute 

of Medicine’s finding that Agent Orange is possibly

related to diabetes, it is now enshrined and benefited

as a service-connected disease, so there might 

be some possibilities to target some appropriate

populations.

National Heart, Lung, and Blood Institute.

Dr. Denise Simons-Morton said the most important

issue for NHLBI regarding diabetes is that diabetes

is a CVD risk factor. In translation research, NHLBI

has projects related to prevention such as diet,

weight control, and physical activity programs. The

most important challenge is balancing the portfolio

with all the basic science that needs to be done

along with the translational research. NHLBI also

has a research continuum, with feedback loops, that

goes from basic research to epidemiological studies

to efficacy RCTs to effectiveness trials to translation

and dissemination research that then results in

translating and disseminating interventions. In this

context, NHLBI is sponsoring the TAAG and ACCORD

trials and the National High Blood Pressure Education Program and the National Cholesterol

Education Program, which are not research programs but are translational.

The Action to Control Cardiovascular Risk in

Diabetes (ACCORD) is partly an efficacy and partly

an effectiveness trial asking if intensive control of

glycemia in adults (less than 6 percent HbA1c vs.

the average 7.5 percent) would prevent CVD events.

This study of 10,000 participants also will ask blood 

pressure and lipid questions. It will be implemented

in 60 clinical sites across the United States and

Canada, including HMOs, VA sites, Canadian health

systems sites, and private doctors’ offices. Thus,

ACCORD will test the HbA1c reduction intervention

in settings where patients are normally seen.

Patient characteristics have been selected to be 

generalizable also.

The Trial of Activity in Adolescent Girls (TAAG) is

another relevant study that is being implemented in

36 schools nationwide with a representative sample

of minority students. TAAG’s purpose is to study a

school-community link to intervention to prevent the

decline in activity seen in adolescence, particularly

in girls. It is really a primordial prevention study of

sedentariness. Phase I was a needs assessment. After

the intervention, there will be a sustainability evaluation, which is important for programs to be implemented in the real world.
DMICC ANNUAL REPORT 132 FY 2002

An example of translation research is the Activity

Counseling Trial, an RCT to test patient education

and counseling approaches for physical activity. The

interventions were designed to be feasible and

appropriate for delivery in primary care settings.

The completed study was published in 2001 and

showed an effect in women but not in men. CATCHON is an example of an observational study of the

implementation and institutionalization of the 

previous CATCH (Child and Adolescent Trial for

Cardiovascular Health) school-based intervention.

These are examples of an RCT that tested real-life

interventions in real-life settings and an observational study to identify the characteristics of schools

that would make them adopt an intervention that

was successful in improving diet and physical activity in children. The major characteristic identified

was having a person in the school who was dedicated to behavioral change.

NHLBI just released and funded a Request for

Applications (RFAs) for trials to assess innovative

strategies to improve clinical practice through guidelines. The purpose is to test multi-faceted interventions delivered in clinical practice with the outcomes

being the provider practices. The interventions are

intended to help providers use guidelines that are

evidence-based in heart, lung, and blood diseases.

RCTs were not required, but quasi-experimental

designs were requested in order to have comparison

groups. Needs assessments were encouraged for

phase I. Eight studies have been funded that are

going to provide a lot of experience relevant to diabetes. Other investigator-initiated studies are testing

similar events.

NHLBI recently had a retreat on translation to discuss both the bench to bedside and bedside to 

community steps. One of the results of that retreat 

is a new policy, which has been posted on the 

Web, that NHLBI will require dissemination plans 

in RFAs, Request for Proposals (RFPs), and large

investigator-initiated studies for clinical or public

health research.

NHLBI is making a strong effort to make data available for epidemiologic studies and clinical trials.

There are a number of data sets that are available

now from Framingham and the epidemiologic studies. Within the next year, additional clinical trial

data will be available from NHLBI.

Dr. Simons-Morton noted that NHLBI also has training programs for clinical researchers, as do other

NIH groups.

Discussion. Dr. Glasgow mentioned that each 

group has a research model going from basic

research to translation and these models are useful.

However, because of time, occasionally there is a

problem going from one stage to another, particularly from efficacy (tested under experimental design

conditions) to effectiveness (Does it work in the 

real world?).

Dr. Simons-Morton agreed that these were excellent

points and ones NHLBI staff had discussed frequently in designing studies. In ACCORD, they conducted a vanguard phase in all 60 clinics because

they wanted to know, although this was an efficacy

study, that the intervention being tested could actually be implemented in the real world. It takes time

and resources to reduce HbA1c to 6 percent and stay

there, so the next question may be will it be implemented. In the history of CVD, researchers have

asked in efficacy trials the causal question or proof

of principle question: Is hypertension a risk factor

for CVD and stroke? The way one proves evidence of

causality is to have experimental evidence that lowering blood pressure prevents or reduces CVD and

stroke events. Internal validity has been considered

the most important thing, but now, there is a move

toward valuing external validity and generalizability.

Dr. Simons-Morton stated that NHLBI is putting a 

lot of resources into ACCORD to do intensive glycemia treatment. If the study finds that there is a

significantly positive effect, there will be a question

of whether or not providers will or can do this. If the

effect is not positive, then they will know that it is

not worth their time.
DMICC ANNUAL REPORT 133 FY 2002

In response to Dr. Green’s query about the results 

of CATCH, and what CATCH-ON will do differently,

Dr. Simons-Morton explained that CATCH was a 

randomized school-based trial of 96 schools randomized to intervention and control. The intervention

being tested was a health promotion intervention to

improve diet and physical activity in elementary

school-age children. The primary outcome was identified as blood cholesterol. Improvements were

achieved in diet and physical activity, but there was

not a significant effect in blood cholesterol. Still the

intervention was considered worthwhile because of

the improvements in the health behaviors. It was

then decided to do a followup observational study 

of three groups, the original CATCH intervention

schools, the original CATCH control schools, and a

naïve group of schools selected to be roughly comparable. For the original intervention schools, the questions were “was the intervention institutionalized,

was it maintained, and what were the factors 

associated with that, if it was.” The control schools

were given all the materials and brief training 

and the question was whether or not the program

was adopted. The third group was used for comparison for secular trends. As mentioned earlier, the

most important factor for maintenance, institutionalization, or adoption was a change agent or a 

dedicated person who was committed to having 

the program happen in the school.

NIDDK. Dr. Garfield reiterated that studies such 

as DCCT clearly have no purpose unless they are

translated. One approach NIDDK has taken is to

implement a translation research program. A recent

program announcement is asking for studies that

involve translation of known effective interventions.

The proposals are reviewed by the Institute’s review

branch. There is also an R21 small grant program to

make it easier for persons to develop pilot data to

feed into the translation research program. NIDDK is

clearly emphasizing translation and setting up programs to promote that. The NDEP that NIDDK and

CDC co-fund is also a translation program and is

actively developing plans to disseminate and implement the DPP results.

Discussion. Dr. Williams asked how NIDDK sees the

implementation of the DPP results in the general

population. Dr. Garfield responded that HRSA is developing interventions to try to study that in their

community centers and NIDDK’s translation research

program will assist with that. NIDDK is also working

with the Indian Health Service, which is developing

plans to implement DPP lifestyle intervention programs. NIDDK is also working with ADA to develop

recommendations based on the DPP results. Dr.

Malozowski added that NIDDK is working with the

DPP nutritionists and those who implemented the

intervention to put together a toolbox based on DPP

to distribute to practitioners to help them implement

the intervention.

Dr. Spiegel commented that Dr. Williams’ question

touches on the crux of the issue with DPP. In a clinical trial population, motivation is always a factor

that limits generalizability. However, in DPP, by

selecting 45 percent of the participants from minority groups, the rationale was that it should be generalizeable to the U.S. population, in contrast to the

earlier Finnish study, with the caveat of having to

motivate individuals. The two critical challenges to

real-world effectiveness are first, identifying those 

at risk, which was done in DPP through the formal

oral glucose tolerance testing, an issue we have been

in dialogue about. The second issue is about implementing the highly structured, individualized, intensive lifestyle intervention that was shown to be

effective; the calculations are that that cannot be

done on a population basis simply in terms of available trained individuals and cost. Other interesting

implications are that metformin, which is now generic, was shown to be equally effective to lifestyle in a

subset of individuals with a body mass index (BMI)

over 34 or 35 and age 25 to 44. So one issue will be

pharmacological intervention and the cost effectiveness and implementation of that, which does not

raise all the lifestyle issues. Returning to the first

challenge, the identification of the target population,

Dr. Spiegel said that it is not the message of DPP to

suggest that there is no need to select individuals

since the lifestyle changes would be good for everyone. The question is should persons be identified by
DMICC ANNUAL REPORT 134 FY 2002

a checklist or a questionnaire, as has been done for

cardiovascular risk, in which family history, obesity,

membership in a minority population, sedentary

behavior, and so forth are assessed. How would such

a questionnaire track as a surrogate for formal glucose tolerance testing, which raises more complex

questions about which test is appropriate.

Dr. Williams said that CDC is discussing these 

issues and as Dr. Spiegel clearly illustrated, there are

no easy answers to the questions. Eventually, there

probably would have to be some surrogate measures

developed for administering the oral glucose tolerance test, possibly specific items in the patient’s history that would indicate increased risk for impaired

glucose tolerance. Those at risk might—only might—

then be included in a testing program. Dr. Williams

thought that developing such surrogate measures 

are a major stumbling block in translating DPP’s

results to a broader population.

Dr. Spiegel stated that the studies in the NIDDK

translation research program that Dr. Garfield

referred to are potentially important vehicles for

testing hypotheses for identification and for 

modified lifestyle interventions.

Dr. Pogach said that one of his concerns about DPP

implementation and generalizability issues was that

the control groups did as well as they did, even

though poorly, perhaps because they had access to

one annual session with a diabetes educator, which

is more than most people ever have, and they seemed

to be a highly motivated, self-selected group who

exercised more than most Americans do, although

they had no significant weight loss. Also, for some

persons in the VA population, vigorous exercise

might be difficult because of knee problems and

other health problems.

Dr. Spiegel and Dr. Garfield pointed out that 11 

percent of the control group per year developed diabetes and that the intervention group attained an

overall 4 to 5 percent weight loss and actually exercised more minutes per week than requested. In fact,

exercise was the most adhered to component of the

lifestyle intervention.

Dr. Simons-Morton commented that the issue of the

control group comes up over and over in CVD trials.

What is appropriate to deliver to the control group is

one issue and another are the changes seen over time

in the control group, but the internal validity of the

study is still a comparison between the control and

intervention group. In randomizing people who agree

to go into one or the other group, there is often a

highly selected group in terms of motivation whether

or not they are representative in terms of gender,

minority status, or other characteristic. Clinical trials in general have to deal with this issue.

Dr. Malozowski added that in drug trials, the

patients tend to be more homogenous than they 

were in DPP. An interesting result in DPP was that

patients in the control group did not gain weight as

it had been expected they would, possibly due to the

difference of participating in a study versus not participating in a study. He felt that it was very important information that elderly patients in particular

benefited substantially from the exercise.

Dr. Peter Savage, NHLBI, stated that DPP was an

extremely valuable study because no one would even

be talking about preventing diabetes if the time and

effort had not been taken to do a study of this sort.

This is a good illustration of why there is a need for

fairly complex clinical trials to change the mindset.

The speculation is, however, that it was a complicated enough study in terms of effort and cost so if

these data are turned over to relatively low-level

efforts in routine clinical settings, there is a likelihood that there might not be a major reduction in

development of type 2 diabetes. He asked if there
DMICC ANNUAL REPORT 135 FY 2002

was a need for some other type of more formal

research studies, maybe treatment for 6 months or 

a year with an insulin sensitizer—which drug companies are studying— plus some form of weight loss

regimen and then stopping to see if persons can be

kept non-diabetic for a period. Such a study could

bridge the gap between an expensive, complicated

intervention and something more affordable that

could be done in a clinical setting.

Dr. Speigel responded that Dr. Thomas Buchanan 

had just published in Diabetes his study of the

insulin sensitizing drug troglitazone, which has now

been withdrawn, in gestational diabetes in Hispanic

women. He had strikingly positive effects, which

offers a theoretical framework of beta cell preservation. There was an arm of DPP that involved troglitazone that was discontinued after 9 months due 

to safety concerns and the group given modified

lifestyle. The data from that group is not yet publicly

available, but it will be at some point and it may 

be a test of what Dr. Savage just proposed because

the group will have been treated with medication 

for a while and then lifestyle. A paper on data from

this group is nearing completion, according to 

Dr. Garfield.

Dr. Pogach referred to a screening issue in the

European UKPDS study about whether early detection for type 2 diabetes will actually improve 

outcomes. In general, it is thought that there is

insufficient evidence to recommend screening for

type 2 diabetes in the general population because 

it is unknown whether or not outcomes will be

improved. Hypotheses could be posed that more 

rigorous treatment of the risk factors would improve

outcomes. But these are questions for which there

are not yet answers. The intensive nature of DPP 

has meant that there is a sense of caution about 

its adaptation. The question remains as to where 

the effort and resources should be put. That is different than saying who should lose weight and who

should exercise.

Dr. Garfield said that the outcome study from the

DPP is following all of the newly diagnosed patients

and is the only cohort for which it is known, within 

a 6 month window, when a person became diabetic.

Dr. Glasgow suggested the group consider the situation if the DPP results had been reversed and the

pharmacological intervention had been dramatically

more effective than the behavioral intervention. The

current discussions would probably not be taking

place. There would not be much concern about the

run-in period. There would not be any consideration

about the fact that drugs are never implemented in

the real world the way they are in an efficacy studies. There is a huge multi-billion dollar industry out

there to support their implementation. This is a cultural mind-shift issue that is real and needs to be

studied, but often different standards and issues

arise because of how we have been trained in our

culture.

Dr. Simons-Morton supported this point by commenting that there was an extensive effort in DPP 

to achieve the level of compliance for the metform

in arm that they needed. Dr. Garfield added that just 

as there was a lifestyle corps to help people adhere,

there was a drug corps for adherence..

Dr. Savage said that exercise may be more efficacious

in preventing diabetes than in helping those who

already have diabetes in terms of the levels at which

people are likely to exercise, although some people

may do spectacular things with diet and exercise.

There are spun-off questions from the DPP that are

not likely to be asked in the community and need to

be followed up by NIH. Another question is the use

of the fasting glucose test to screen for high-risk

people. There are some large data sets from people

who have been tested and followed for some time

that are becoming available for public use from

NIDDK and NHLBI. These will provide an opportunity to analyze that data and see if there is some combination of obesity and fasting glucose that would

be a reliable predictor of diabetes risk and substitute for a formal oral glucose tolerance test. Dr.

Garfield said they were also analyzing the effects 

of exercise versus weight loss.
DMICC ANNUAL REPORT 136 FY 2002

Agency for Healthcare Research and Quality

(AHRQ). Dr. Daniel Stryer said that AHRQ is a relatively small agency that is tasked with research 

on all problems within the “ICD-9 book” for all populations and in all settings, which becomes a bit 

overwhelming. Therefore, AHRQ cannot concentrate

too many resources on diabetes, although it is obviously a major cause of morbidity and mortality.

AHRQ is focused on the delivery of health care, so

the agency is looking at clinical issues, but also at

organizational and structural factors, which is

important in translational research. In AHRQ studies, the agency is looking at these factors to understand the interplay between the organizational and

structural levels and to understand some of the 

subtleties in interventions that make them work 

in one setting and not another.

AHRQ does go through the efficacy and effectiveness

stages mentioned by the other speakers and other

DMICC members. The agency refers to translation 

as implementation or TRIP, Translating Research

Into Practice. The TRIP 1 initiative focused on efficacy. TRIP 2 was more of an effectiveness model. The

agency is now in a third generation of implementation research and has issued a TRIP 3 Public

Announcement in partnership with the VA. AHRQ is

also a partner with NIDDK in its new RFA for translational research in prevention and control of diabetes. In this third generation, AHRQ is especially

interested in the factors that account for variability

in success or failure from one setting to another.

This is considered important for generalizability 

and for adjusting or selecting one intervention or

another in a particular setting.

Dr. Stryer said that the research base is important,

but tools are also needed. There is no off-the-shelf

intervention, most need to be adapted, but a lot of

good work is taking place and it is unnecessary for

everyone to reinvent the wheel. AHRQ is developing 

a tool box—or maybe a tool shed—that is going to

come out in about a year to put these tools in the

public domain.

Dr. Stryer stressed that partnerships are another

important level in translation research. There is a

chasm between what is known from research and

what is being put into practice. A key in implementing findings is going to be developing partnerships

with those on the front line of health care to understand their needs and address them, but also to get

them involved early in the process in the research so

they will come to the agencies with their needs and

learn what is available. Dr. Styer said that establishing this level of partnership does not just happen;

there is a science to it.

AHRQ’s partnership with HRSA will assess the

Health Disparities Collaboratives to enhance the

research basis for quality improvement. It will look

at real world situations; it is not an efficacy model.

It is getting at the failure and success factors, generalizability, sustainability, and return on investment.

All of which are important next steps for translation.

Discussion. In response to Dr. Green’s inquiry about

AHRQ’s activities in community-based participatory

research, Dr. Stryer said this sprung up from the disparities initiative but is also a part of implementation. This is really a subset of user-driven research.

The communities are one of the types of users that

AHRQ feels it needs to reach out to and ensure that

their needs are being met. It is very important that

these users are incorporated into all stages of the

research process from identifying a topic, to development of the question, the development of the

hypothesis, the actual choice of methods, the analysis, and the implementation. This is a key component

of AHRQ’s implementation research.
DMICC ANNUAL REPORT 137 FY 2002

Health Resources and Services Administration

(HRSA). Dr. David Stevens said that the most important issue in translation research for HRSA is the

change in practice from the acute to the chronic care

model. To do that involves four main elements. First,

HRSA is using a learning model and Dr. Ed Wagner’s

improvement model that relies on productive interactions between a prepared, proactive, practice team

and an informed, activated patient and interactions

with community resources and policies and the

health system. Second, the agency has a leadership

program at the national and local levels. The third

element is the agencies strategic partnerships.

Fourth, and of major importance, is a heavy investment (nearly $20 million) and effort in building

infrastructure at the State and national levels.

Dr. Stevens said there is a difference between

research and quality improvement. HRSA does not

do research to generate knowledge; they do evaluation, so their methods are different than those of

researchers. One difference is that research uses

blinded tests, and HRSA’s are observable. Other differences are researchers are looking for no bias,

whereas HRSA studies have a stable bias; researchers collect all possible data and HRSA wants

just enough data to know if they are accomplishing

what they want. Research works from fixed hypotheses; HRSA studies have changing hypotheses. In

research, there is one large test and HRSA has many

hundreds of sequential small tests. Research has

stable cohorts; HRSA has a changing population.

In answer to the question about HRSA’s unique 

role, Dr. Stevens explained that 86 percent of the

patient population the agency works with are low

income persons, 40 percent are uninsured, 28 percent

are African American, 30 percent are Hispanic, and 

8 percent are Asian. This is a very important population to be serving. HRSA has gone into many clinical

areas with its model—diabetes, depression, CVD,

asthma, and cancer. There is a potential synergism

and HRSA has found a tremendous affinity with

changes across the conditions, which is good news

for a provider, because it means there is a finite

number of things to do to produce multiple 

good results.

Dr. Stevens said he believed that DMICC can do a

great deal in providing national leadership on the

importance of translational research. This can help

in removing barriers and making change in policy.

It says that what agencies like HRSA is doing is

important; it is not marginalized. It also provides

HRSA with access to information. Dr. Stryer said that

HRSA is actually a researcher’s customer. There is 

no reason for HRSA to duplicate the expertise of the

research agencies, and they are not equipped to do

so. That is why HRSA wants to partner with the

research groups. In return, HRSA can provide access

to populations and provide information on spreading

innovation to change and improve health care practices to complement what researchers are doing.

Dr. Stevens stressed that it is important to involve

early on those to whom the research is going to be

applied. This should be as early as at the hypothesis

stage in the clinical research stage. HRSA is translating DPP now, but Dr. Stevens wishes they had been

involved when the study was being designed. He said

that the use of the DPP results is exciting, even

though there are problems to be resolved. However,

they wish that the study had considered a non-biological test to identify the target population or tested less than a 150-minute per week exercise intervention, even though this would have cost more

money. It would be good to build in collaboration

earlier. It could shorten the time. Currently, it has

been found that 14 percent of original research takes

8 years to get into practice. It would help to have

persons who can straddle the world of research and

the world of application. If they do not exist, they

should be trained.
DMICC ANNUAL REPORT 138 FY 2002

Dr. Stevens said he sees translation research as

developing inter-disciplinary discipline. If the 

translation units within NIH and CDC would form 

a collaborative themselves and had an overall strategy for moving the field forward, that would be

tremendously helpful to HRSA. There would be less

duplication and more synergism, and it would be

easier for those who are in systems to get more feedback to the collaborative. This could be an ongoing

activity, where the translation work results could be

evaluated. Dr. Stevens said that every month he has

outcomes and does not have time to look at the data.

He suggested that this is true for the VA and NIDDK

and it could be of interest and use to a larger group

such as a collaborative.

HRSA does expect to have outcomes from its prototype of five CHCs on the DPP translation by July or

August 2003. There will also be important outcomes

from the work with AHRQ. Dr. Stevens said he would

like to share those results in a group such as DMICC

where it might influence research questions of colleagues in other agencies or in academia.

Discussion. Dr. Spiegel expressed his appreciation 

to the speakers and the attendees for their participation and acknowledgement of the 25th anniversary of the DRTCs and their important work. He 

said he felt a renewed sense of partnership and of

the importance of collaboration. It needs to be made

meaningful, and Dr. Speigel intends to work with 

the group in that capacity.

Dr. Pogach asked if there would be another meeting

on translation that might bring together other NIH

groups with DMICC. Dr. Spiegel responded that 

such a forum need not be limited to DMICC meetings. Dr. Williams said that CDC would strongly 

support such a meeting or conference, and it could

include scientists from other organizations and 

from academia also.

The meeting was adjourned at 2:35 p.m.
DMICC ANNUAL REPORT 139 FY 2002

Participants

Kristin Abraham, PhD

Director, Cell Signaling Programs

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 607

Bethesda, MD 20892-5460

Tel: (301) 451-8048

Fax: (301) 480-3503 

abrahamk@extra.niddk.nih.gov

Richard Anderson, MD, PhD

Program Director, Division of Genetics 

and Development Biology

National Institute of General Medical Sciences

National Institutes of Health

45 Center Drive, MSC 6200

Natcher Building, Room 2AS-25

Bethesda, MD 20892

Tel: (301) 594-0943

Fax: (301) 480-2228 

andersor@nigms.nih.gov

Ricardo Brown, PhD

Program Director, Biomedical Research Branch

Division of Basic Research

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

6000 Executive Boulevard, MSC 7003

Willco Building, Room 402

Bethesda, MD 20892-7003

Tel: (301) 443-2239

Fax: (301) 594-0673 

ricbrown@mail.nih.gov

Francisco Calvo, PhD

Chief, Review Branch

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 752

Bethesda, MD 20892

Tel: (301) 594-8897

Fax: (301) 480-3505 

calvof@extra.niddk.nih.gov

Michelle Cissell, PhD

AAAS/NIH Science Policy Fellow

Office of Scientific Program and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A05

Bethesda, MD 20892

Tel: (301) 496-6623

Fax: (301) 480-6741 

cissellm@extra.niddk.nih.gov

Laura Cole, PhD

Senior Policy Analyst

Office of Scientific Program and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A16, MSC 2560

Bethesda, MD 20892-2560

Tel: (301) 496-6623

Fax: (301) 480-6741 

colel@extra.niddk.nih.gov
DMICC ANNUAL REPORT 140 FY 2002

Catherine Cowie, PhD

Director, Type 1 Diabetes Clinical Trials Program

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 691

Bethesda, MD 28092-5460

Tel: (301) 594-8804

Fax: (301) 480-3503 

cowiec@extra.niddk.nih.gov

Jeffrey Cutler, MD

National Heart, Lung and Blood Institute

National Institutes of Health

Rockledge 2, Room 8130

Bethesda, MD 20892

Tel: (301) 435-0414

cutlerj@nhlbi.nih.gov

Maria Davila-Bloom, PhD

SRA/NIDDK Review Branch

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard,

Room 758, MSC 5452

Bethesda, MD 20892-5452

Tel: (301) 594-7637

Fax: (301) 480-3505 

davila-bloomm@extra.niddk.nih.gov

Thomas Eggerman, MD, PhD

Director, Islet Transplantation Program

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 697

Bethesda, MD 20892-5460

Tel: (301) 594-8813

Fax: (301) 480-3503 

eggermant@extra.niddk.nih.gov

Jody Evans

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Room 713

Tel: (301) 594-8843

evansj@extra.niddk.nih.gov

Lawrence Fine, PhD

Medical Advisor

Office of Behavioral and Social Sciences Research

National Institutes of Health

1 Center Drive

Building 1, Room 256

Bethesda, MD 20892

Tel: (301) 435-6780

Fax: (301) 402-1150 

finel@od.nih.gov
DMICC ANNUAL REPORT 141 FY 2002

Carol Feld

Director, Office of Scientific Program 

and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A07

Bethesda, MD 20892

Tel: (301) 496-6623

Fax: (301) 480-6741 

feldc@extra.niddk.nih.gov

Sanford Garfield, PhD

Senior Advisor, Biometrics and Behavioral Science

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Room 685

Bethesda, MD 20892-5460

Tel: (301) 594-8803

Fax: (301) 480-3503 

garfields@extra.niddk.nih.gov

Alan Guttmacher, MD

Senior Clinical Advisor to the Director

National Human Genome Research Institute

National Institutes of Health

31 Center Drive, MSC 2152

Building 31, Room 4B09

Bethesda, MD 20892-0844

Tel: (301) 402-0955

Fax: (301) 402-0837 

guttmach@mail.nih.gov

Stephen James, MD

Deputy Director

Division of Digestive Diseases and Nutrition

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 675, MSC 5450

Bethesda, MD 20892

Tel: (301) 594-7680

Fax: (301) 480-8300 

jamess@extra.niddk.nih.gov

Mary Beth Kester 

Program Analyst

Office of Scientific Program and Policy Analysis

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A05

Bethesda, MD 20892

Tel: (301) 496-6623

Fax: (301) 480-6741 

kesterm@extra.niddk.nih.gov

Jon Kerner 

National Cancer Institute

National Institutes of Health

6130 Executive Boulevard

Rockville, MD 20852

Tel: (301) 594-7294

Fax: (301) 594-6787 

kernerj@mail.nih.gov

Richard Knazek, MD

Medical Officer

Clinical Research

National Center for Research Resources

National Institutes of Health

6705 Rockledge Drive, MSC 7965

One Rockledge Centre, Room 6030

Bethesda, MD 20892

Tel: (301) 435-0790

Fax: (301) 480-3661 

richardk@ncrr.nih.gov
DMICC ANNUAL REPORT 142 FY 2002

Maren R. Laughlin, PhD

Director, Metabolism Program

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 6101

Bethesda, MD 20892-5460

Tel: (301) 594-8802

Fax: (301) 480-3503 

maren.laughlin@nih.gov

Barbara Linder, MD, PhD

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 699

Bethesda, MD 20892

Tel: (301) 594-0021

Fax:(301) 480-3503 

linderb@extra.niddk.nih.gov

Robert Kuczmarski, Dr.P.H.

Director, Obesity Prevention and Treatment Program

Division of Digestive Diseases and Nutrition

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 673, MSC 5450

Bethesda, MD 20892-5450

Tel: (301) 451-8354

Fax: (301) 480-8300 

rk191r@nih.gov

Saul Malozowski, MD, PhD, MBA

Senior Advisor for Clinical Trials 

and Diabetes Translation

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Room 679

Bethesda, MD 20892

Tel: (301) 451-4683

Fax: (301) 480-3503 

malozowskis@extra.niddk.nih.gov

Carolyn Miles

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Room 641

Bethesda, MD 20892-5452

Tel: (301) 594-7791

milesc@extra.niddk.nih.gov

Judith Podskalny, PhD

Program Director, Division of Digestive 

Diseases and Nutrition

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Room 667, MSC 5450

Bethesda, MD 20892-5450

Tel: (301) 594-8876

Fax: (301) 480-8300 

podskalnyj@extra.niddk.nih.gov
DMICC ANNUAL REPORT 143 FY 2002

Patricia Robuck, PhD, MPH

Director, Clinical Trials Program

Division of Digestive Diseases and Nutrition

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 659

Bethesda, MD 20892

Tel: (301) 594-8879

Fax: (301) 480-8300 

pr132q@nih.gov

Peter Savage, MD

Acting Director, Division of Epidemiology 

and Clinical Applications

National Heart, Lung and Blood Institute

National Institutes of Health

Rockledge 2, Room 8104

Bethesda, MD 20817

Tel: (301) 435-0421

Fax: (301) 480-1864 

savagep@nhlbi.nih.gov

Marcia Scott

Prevention Research Branch

National Institute on Alcohol Abuse and Alcoholism

National Institutes of Health

6000 Executive Boulevard, Suite 505

Bethesda, MD 20892

Tel: (301) 402-6328

Fax: (301) 443-8774 

mscott@mail.nih.gov

Salvatore Sechi, PhD

Director, Proteomic Program

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 611

Bethesda, MD 20892-5460

Tel: (301) 594-8814

Fax: (301) 480-2688 

Salvatore_Sechi@nih.gov

Robert Selwitz, PhD

Senior Dental Epidemiologist

National Institute of Dental 

and Craniofacial Research

National Institutes of Health

Natcher Building, 3AN-44D

Bethesda, MD 20892

Tel: (301) 594-3977

Fax: (301) 480-8254 

selwitzr@de45.nidr.nih.gov

Elliott Siegel, PhD

Associate Director of Health 

Information Program Development

National Library of Medicine

National Institutes of Health

8600 Rockville Pike

Bethesda, MD 20892

Tel: (301) 496-8834

Fax: (301) 496-4450 

siegel@nlm.nih.gov

Elizabeth Singer

Director, Office of Communications 

and Public Liaison

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

31 Center Drive

Building 31, Room 9A04

Bethesda, MD 20892

Tel: (301) 496-3583

Fax: (301) 496-7422 

singerb@extra.niddk.nih.gov
DMICC ANNUAL REPORT 144 FY 2002

Allen Spiegel, MD

Director

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

9000 Rockville Pike

Building 31, Room 9A52

Bethesda, MD 20892

Tel: (301) 496-5877

Fax: (301) 496-9943 

spiegela@extra.niddk.nih.gov

Robert Star, MD

Chief, Renal Diagnostics and Therapeutics

National Institutes of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

Building 10, Room 3N108, MSC 1268

Bethesda, MD 20892-1268

Tel: (301) 402-6749

Fax: (301) 402-0014 

starr@extra.niddk.nih.gov

Dorothy West

Program Analyst

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard

2 Democracy Plaza, Room 687

Bethesda, MD 20892

Tel: (301) 594-8820

Fax: (301) 480-3503 

westd@extra.niddk.nih.gov

Desmond Williams, MD, PhD

Centers for Disease Control and Prevention

4770 Buford Highway, N.W.

Atlanta, GA 30341

Tel: (770) 488-1158

Fax: (770) 488-5966 

zhx0@cdc.gov

Violet Woo, MS, MPH

Program Analyst

Office of Minority Health

Department of Health and Human Services

5515 Security Lane, Suite 1000

Rockville, MD 20852

Tel: (301) 443-9923

Fax: (301) 443-8280 

vwoo@osophs.dhhs.gov
DMICC ANNUAL REPORT 145 FY 2002

Speakers

Kelly Acton, MD, MPH

Director, National Diabetes Program

Headquarters Office

Indian Health Service

5300 Homestead Road, NE

Albuquerque, NM 87110-1293

Tel: (505) 248-4182

Fax: (505) 248-4188 

kelly.acton@mail.ihs.gov

Marshall Chin, MD, MPH

Associate Professor of Medicine

University of Chicago

5841 South Maryland Avenue

MC2007, Room B216

Chicago, IL 60637

Tel: (773) 702-4769

Fax: (773) 834-2238 

mchin@medicine.bsd.uchicago.edu

Judith Fradkin, MD

Director, Division of Diabetes,

Endocrinology and Metabolic Diseases

National Institute of Diabetes 

and Digestive and Kidney Diseases

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Room 689

Bethesda, MD 20892-5460

Tel: (301) 594-8814

Fax: (301) 480-3503 

fradkinj@ep.niddk.nih.gov

Russ Glasgow, PhD

Senior Scientist

Kaiser Permanente Clinical Research Unit

Post Office Box 349

Canon City, CO 81215

Tel: (719) 275-6540

Fax: (719) 275-5704 

russg@ris.net

Lawrence W. Green, Dr.P.H.

Director, Office of Extramural Prevention Research

Associate Director for Prevention Research 

and Academic Partnerships

Centers for Disease Control and Prevention

4770 Buford Highway, N.W.

Mail Stop K-56

Atlanta, GA 30341-3724

Tel: (770) 488-2458

Fax: (770) 488-8200 

lgreen@cdc.gov

Roland Hiss, MD

Professor of Medicine and Chair

Department of Medical Education

University of Michigan Medical School

G1103 Towsley Center

Ann Arbor, MI 48109

Tel: (734) 763-1426

Fax: (734) 936-1641 

redhiss@umich.edu

Harlan Krumholz, MD

Professor of Medicine and Epidemiology 

& Public Health

Yale School of Medicine

333 Cedar Street

PO Box 208025

New Haven, CT 06520-8025

Tel: (203) 737-1717

Fax: (203) 737-1718 

harlan.krumholz@yale.edu

Leonard Pogach, MD, MBA

National Program Director Diabetes

Veterans Health Administration

East Orange Veterans Affairs Medical Center

385 Tremont Avenue

East Orange, NJ 07019-1095

Tel: (973) 676-1000 ext.1095

Fax: (973) 677-4408 

leonard.pogach@med.va.gov
DMICC ANNUAL REPORT 146 FY 2002

David Stevens, MD, FAAFP

Director, Clinical Branch

Division of Community and Migrant Health

Health Resources and Services Administration

4350 East West Highway, 7th Floor

Bethesda, MD 20814

Tel: (301) 594-4323

Fax: (301) 594-4997 

dstevens@hrsa.gov

Daniel Stryer, MD

Center for Outcomes and Effectiveness Research

Agency for Healthcare Research and Quality

6010 Executive Boulevard, Suite 300

Rockville, MD 20852

Tel: (301) 594-4038

Fax: (301) 594-3211 

dstryer@ahrq.gov
APPENDICES
DMICC ANNUAL REPORT 149 FY 2002

NATIONAL DIABETES MELLITUS RESEARCH AND EDUCATION ACT, SECTION 429: 

Interagency Coordinating Committees

Sec.429. [285c—3] 

(a) For the purpose of —

(1) better coordination of the research activities of all the national research institutes relating to 

diabetes mellitus, digestive diseases, and kidney, urologic, and hematologic diseases; and

(2) coordinating those aspects of all Federal health programs and activities relating to such diseases 

to assure the adequacy and technical soundness of such programs and activities and to provide 

for the full communication and exchange of information necessary to maintain adequate 

coordination of such programs and activities;

the secretary shall establish a Diabetes Mellitus Interagency Coordinating Committee, a Digestive Diseases

Interagency Coordinating Committee, and a Kidney, Urologic, and Hematologic Diseases Coordinating Committee

(hereafter in this section individually referred to as a “Committee”).

(b) Each committee shall be composed of the Directors of each of the national research institutes and 

divisions involved in research with respect to the diseases for which the Committee is established,

the Division Director of the Institute for the diseases for which the Committee is established, the 

Chief Medical Director of the Veterans’ Administration,1 and the Assistant Secretary of Defense for

Health Affairs (or the designees of such officers) and shall include representation from all other

Federal departments and agencies whose programs involve health functions or responsibilities 

relevant to such diseases, as determined by the Secretary. Each Committee shall be chaired by the

Director of NIH (or the designee of the Director). Each committee shall meet at the call of the 

chairman, but not less often than four times a year.

(c) each Committee shall prepare an annual report for —

(1) the Secretary;

(2) the Director of NIH; and

(3) the Advisory Board established under section 430 for the diseases for which the Committee 

was established, detailing the work of the Committee in carrying out paragraphs (1) and 

(2) of subsection (a) in the fiscal year for which the report was prepared. Such report shall be 

submitted not later than 120 days after the end of each fiscal year.

1 The reference is deemed to be a reference to the Under Secretary for Health of the Department of Veteran Affairs.

See section 302 (e)(1) of Public Law 102-405(106) Stat. 1985 and section 10(4) of Public Law 100-527 (102 Stat.2641).

APPENDIX A
DMICC ANNUAL REPORT 151 FY 2002

DIABETES MELLITUS INTERAGENCY COORDINATING COMMITTEE

ROSTER OF MEMBERS (2002)

CHAIRMAN

Allen Spiegel, MD

Director

National Institute of Diabetes and 

Digestive and Kidney Diseases

National Institutes of Health

Building 31, Room 9A52

31 Center Drive, MSC 2560

Bethesda, MD 20892-2560

Tel: (301) 496-5877 

Fax: (301) 402-2125

spiegela@extra.niddk.nih.gov

EXECUTIVE SECRETARY

Sanford Garfield, PhD

Senior Advisor, Biometrics and Behavioral Science

National Institute of Diabetes and 

Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 685

Bethesda, MD 20817

Tel: (301) 594-8803

Fax: (301) 480-3503

E-mail: 

MEMBERS

Agency for Healthcare Research and Quality

Daniel B. Stryer, MD

Medical Officer

Center for Outcomes and Effectiveness Research

6010 Executive Boulevard, Suite 300

Rockville, MD 20852

Tel: (301) 594-4038

Fax: (301) 594-3211

dstryer@ahrq.gov

Center for Scientific Review

N. Krish Krishnan, PhD

National Institutes of Health

Two Rockledge Centre

Room 6164

Bethesda, MD 20892

Tel: (301) 435-1041

Fax: (301) 480-2065

krishnak@mail.nih.gov

APPENDIX B
DMICC ANNUAL REPORT 152 FY 2002

Centers for Disease Control and Prevention

Frank Vinicor, MD

Director, Division of Diabetes Translation

4770 Buford Highway, NW MSK-10

Atlanta, GA 30341

Tel: (770) 488-5000

Fax: (770) 488-5966

fxv1@cdc.gov

Mark Eberhardt, PhD

Epidemiologist

National Center for Health Statistics

6525 Belcrest Road, Room 730

Hyattsville, MD 20782

Tel: (301) 436-5979, x142

Fax: (301) 436-8453

mse1@cdc.gov

Centers for Medicare & Medicaid Services

John P. Lanigan

Health Insurance Specialist

Office of Professional Relations

Hubert Humphrey Building

Room 435H

Washington, DC 20201

Tel: (202) 690-7418

Fax: (202) 401-7438

jlanigan@hcfa.gov

Department of Health and Human Services

Susan J. Blumenthal, MD, MPA

US Assistant Surgeon General

200 Independence Avenue, SW

Room 719H

Washington, DC 20201

Tel: (202) 260-2255

Fax: (202) 690-4631

SBlumenthal@osophs.dhhs.gov

DHHS Office of Minority Health

Violet Woo, MS, MPH

Program Analyst

Department of Health & Human Services

5515 Security Lane, Suite 1000

Rockville, MD 20852

Tel: (301) 443-9923

Fax: (301) 443-8280

vwoo@osophs.dhhs.gov

Food and Drug Administration

Shaio-Wei Shen

Director, Division of Metabolism 

and Endocrine Drug Products

Parklawn Building, Room 14B-45

5600 Fishers Lane

Rockville, MD 20857

Tel: (301) 827-6430

Fax: (301) 443-9282

orloffd@cder.fda.gov 

Health Resources and Services Administration

David M. Stevens, MD, FAAFP

Director, Clinical Branch

Division of Community and Migrant Health

4350 East West Highway, 7th Floor

Bethesda, MD 20814

Tel: (301) 594-4323

Fax: (301) 594-4997

dstevens@hrsa.gov
DMICC ANNUAL REPORT 153 FY 2002

Indian Health Service

Kelly Acton, MD, MPH

Director, National Diabetes Program

5300 Homestead Road, NE

Albuquerque, NM 87110-1293

Tel: (505) 248-4182

Fax: (505) 248-4188

Kelly.acton@mail.ihs.gov

National Center for Complementary 

and Alternative Medicine

Marguerite Klein

Health Science Administrator

6707 Democracy Boulevard

Room 401

Bethesda, MD 20892-5475

Tel: (301) 402-5860

Fax: (301) 480-3621

kleinm@mail.nih.gov 

National Center for Research Resources 

Richard Knazek, MD

Medical Officer

National Institutes of Health

6705 Rockledge Drive

Rockledge 1, Room 6128

Bethesda, MD 20892

Tel: (301) 435-0790

Fax: (301) 480-3661

richardk@ncrr.nih.gov

National Center on Minority Health 

and Health Disparities 

Jean L. Flagg-Newton, MD

Deputy Director

National Institutes of Health

2 Democracy Plaza

6707 Democracy Boulevard, Suite 800

Betheda, MD 20892

Tel: (301) 402-1366

Fax: (301) 402-7040

flaggnej@od.nih.gov

National Eye Institute

Peter Dudley, PhD

Director, Retinal Diseases Program

National Institutes of Health

6120 Executive Boulevard

Suite 350

Rockville, MD 20892

Tel: (301) 451-2020

Fax: (301) 402-0528

pad@nei.nih.gov

National, Heart, Lung and Blood Institute

Peter J. Savage, MD

Acting Director, Division of Epidemiology 

and Clinical Applications

National Institutes of Health

Rockledge 2, Room 8104

Bethesda, MD 20817

Tel: (301) 435-0421

Fax: (301) 480-1864

savagep@nhlbi.nih.gov
DMICC ANNUAL REPORT 154 FY 2002

National Human Genome Research Institute 

Alan E. Guttmacher, MD

Senior Clinical Advisor to the Director

National Institutes of Health

Building 31, Room 4B09

Bethesda, MD 20892-2152

Tel : (301) 496-0844

Fax : (301) 402-0837

guttmach@mail.nih.gov

National Institute of Allergy and 

Infectious Diseases

John Ridge, MD

Program Officer

Diabetes and Autoimmunity Section 

of the Clinical Immunology Branch

National Institutes of Health

6700B Rockledge Drive 

Bethesda, MD 20892

Tel: (301) 496-7104

Fax: (301) 402-2571

jr34g@nih.gov 

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

Julia Freeman, PhD

Chief, Autoimmunity Section

National Institutes of Health

Building 45, Room 5AS-19F

45 Center Drive, MSC 6500

Bethesda, MD 20892-6500

Tel: (301) 594-5052

Fax: (301) 480-4543

freemanj@ep.niams.nih.gov

National Institute of Biomedical Imaging 

and Bioengineering

Joan T. Harmon, PhD

Senior Advisor for Program & Acting Director,

Division of Bioengineering

National Institutes of Health

6707 Democracy Boulevard

Room 241

Bethesda, MD 20892-2077

Tel: (301) 451-4776

Fax: (301) 480-4515

harmonj@nibib.nih.gov

National Institute of Child Health and 

Human Development

Gilman D. Grave, MD

Chief, Endocrinology, Nutrition 

and Growth Branch

Center for Research for Mothers & Children

National Institutes of Health

6100 Executive Boulevard

Suite 4B-11

Bethesda, MD 20892-7510

Tel: (301) 496-5593

Fax: (301) 480-9791

gg37v@nih.gov

National Institute on Deafness and 

Other Communication Disorders

Barry J. Davis, PhD

Scientific Programs Branch

National Institutes of Health

6120 Executive Boulevard

Rockville, MD 20892-7180

Tel: (301) 402-3464

Fax: (301) 402-6251

barry_davis@nih.gov
DMICC ANNUAL REPORT 155 FY 2002

National Institute of Dental and 

Craniofacial Research

Patricia S. Bryant, PhD

Director, Behavior, Health Promotion 

& Environment Program

National Institutes of Health

Building 45, Room 4AS-43A, MSC 6402

Bethesda, MD 20892-6402

Tel: (301) 594-2095

Fax: (301) 480-8322

bryantp@de45.nidr.nih.gov

National Institute of Diabetes and 

Digestive and Kidney Diseases

Judith E. Fradkin, MD

Director

Division of Diabetes, Endocrinology,

and Metabolic Diseases

National Institutes of Health

Building 31, Room 9A27

31 Center Drive MSC 2560

Bethesda, MD 20892-2560

Tel: (301) 496-7348

FAX: (301) 480-6792

jf58s@nih.gov

National Institute of Environmental 

Health Sciences

Perry Blackshear, MD, DPhil

Director, Office of Clinical Programs

National Institutes of Health

PO Box 12233

NIEHS, MD A2-05

RTP, NC 27709

Tel: (919) 541-4899

Fax: (919) 541-4571

black009@niehs.nih.gov

National Institute of General Medical Sciences

Richard Anderson, MD, PhD

Program Director, Division of Genetics 

and Developmental Biology

National Institutes of Health

Natcher Building, Room 2AS-25

45 Center Drive, MSC 6200

Bethesda, MD 20892-6200

Tel: (301) 594-0943

Fax: (301) 480-2228

andersor@nigms.nih.gov

National Institute of Mental Health

Peter Muehrer, PhD

Chief, Health and Behavioral Science

Research Branch

Division of Mental Disorders,

Behavioral Research and AIDS

National Institutes of Health

6001 Executive Boulevard 

Room 6189, MSC 9615

Bethesda, MD 20892-9615

Tel: (301) 443-4708

Fax: (301) 480-4415

pmuehrer@mail.nih.gov

National Institute of Neurological 

Disorders and Stroke

Paul L. Nichols, PhD

Program Director, Systems and Cognitive

Neuroscience Program

National Institutes of Health

6001 Executive Boulevard

Room 2118

Rockville, MD 20892

Tel: (301) 496-9964

Fax: (301) 402-2060

pn13w@nih.gov
DMICC ANNUAL REPORT 156 FY 2002

National Institute of Nursing Research

Nell Armstrong, PhD, RN

Program Director

National Institutes of Health

6701 Democracy Boulevard

Room 710

Bthesda, MD 20817

Tel: (301) 594-5973

Fax: (301) 480-8260

armstrongn@nih.gov

National Institute on Aging

Chhanda Dutta, PhD

Chief, Musculoskeletal Section & Nutrition,

Metabolism, Gastroenterology Section

Geriatrics Program

National Institutes on Health

Gateway Building, Suite 3C-307

7201 Wisconsin Avenue

Bethesda, MD 20893

Tel: (301) 435-3048

Fax: (301) 402-1784

cd23z@nih.gov

National Institute on Alcohol Abuse 

and Alcoholism

Ricardo A. Brown, PhD

Program Director, Biomedical Research Branch,

Division of Basic Research

National Institutes of Health

Willco Building, Room 402

6000 Executive Boulevard, MSC 7003

Bethesda, MD 20892-7003

Tel : (301) 443-2239

Fax : (301) 594-0673

ricbrown@mail.nih.gov

National Institute on Drug Abuse

Jag H. Khalsa, PhD

Pharmacologist Health Administrator

Center on AIDS and Other Medical 

Consequences of Drug Abuse (CAMCODA)

6001 Executive Boulevard, Room 5098

MSC 9593

Bethesda, MD 20892-5953

Tel: (301) 443-1801

Fax: (301) 594-6566

jk98p@nih.gov

National Library of Medicine

Elliot R. Siegel, PhD

Associate Director for Health 

Information Programs Development

National Institutes of Health

8600 Rockville Pike

Bethesda, MD 20817

Tel: (301) 496-8834

Fax: (301) 496-4450

siegel@nlm.nih.gov

Veterans Health Administration

Leonard M. Pogach, MD, MBA

East Orange Veterans Affairs Medical Center

385 Tremont Avenue

East Orange, NJ 07018

Tel: (973) 676-1000, ext. 1693

Fax: (973) 395-7092

Leonard.pogach@med.va.gov