TWENTY-SECOND ANNUAL REPORT OF THE

DIABETES MELLITUS INTERAGENCY COORDINATING

COMMITTEE

FISCAL YEAR 1995

Richard C. Eastman, M.D.

Chairman
TABLE OF CONTENTS

Introduction 1

Legislative Mandate 1

Activities of the DMICC 2

Activities of Member Organizations 3

National Institutes of Health

National Institute of Diabetes

 and Digestive and Kidney Diseases 3

National Institute on Aging 3

National Institute of Allergy

 and Infectious Diseases 5

National Institute of Arthritis and

 Musculoskeletal and Skin Diseases 7

National Institute of Child Health

 and Human Development 7

National Institute of Dental Research 10

National Eye Institute 11

National Institute of General

 Medical Sciences 13

National Heart, Lung, and Blood Institute 14

National Institute of Neurological

 Disorders and Stroke14

National Institute of Nursing Research 15

National Center for Research Resources 17
National Center for Human Genome Research 19

Division of Research Grants 19

Agency for Health Care Policy and Research20

Centers for Disease Control and Prevention 20

National Center for Health Statistics 20

Food and Drug Administration 22

Health Resources and Services Administration 23

Indian Health Service 25

Veterans Health Administration 26

Appendix A: DMICC Legislative Authority 29

Appendix B: Roster of DMICC Members 30
INTRODUCTION

In accordance with Section 429 of the Public Health 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, and the Director

of the National Institutes of Health. This is the annual report of the DMICC for Fiscal

Year (FY) 1995.

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 National Institutes of Health 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, National Institutes of Health, is the Director, Division of Diabetes,

Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and

Kidney Diseases. In FY 1995, the DMICC membership included representatives of 20

Federal organizations and a liaison representative with the American Diabetes

Association (ADA). A roster of Committee members 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 their

progress. The DMICC collects fiscal data to document diabetes-related expenditures

from each agency. A summary of these expenditures for FY 1995 is presented in

Appendix C.

In FY 1995, the DMICC focused its efforts in two specific areas. First, the Committee

held several meetings to begin to develop an approach for establishing the National

Diabetes Education Program (NDEP) by translating the results of the Diabetes

Complications and Control Trial (DCCT) to both the lay public and health professionals.

The release of the DCCT results provides a focused message for diabetes patients to

control their blood glucose levels. Second, the DMICC cosponsored with the National

Diabetes Information Clearinghouse (NDIC) a conference on Diabetes in Native

Americans: The Eastern Tribes, held in November 1994. The conference addressed

issues such as metabolic factors influencing diabetes in Native Americans, the influence

of American Indian culture in diabetes, and attitudes and beliefs of Native American

patients with diabetes.

The DMICC intends to continue formulating plans for the NDEP as well as to pursue

projects that focus on bringing together in-depth information from the diverse programs

represented by the member organizations; to be the catalyst for the initiation of projects;

and to guide the progress of projects involving several agencies.
ACTIVITIES OF MEMBER ORGANIZATIONS

The DMICC is pleased to present the following summary of diabetes-related activities

reported by organizations represented on the Committee.

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

??

National Institute on Aging (NIA)

The mission of the NIA is to conduct and support biomedical, social, and behavioral

research, training, health information dissemination, and other programs related to the

aging process and the diseases and other special problems and needs of the aged.

Diabetes-related research is one of many areas supported by the NIA.

Highlights of recent support:

• The NIA supported research in mechanisms involved in the development of

glucose intolerance/insulin resistance during normative aging, including the role

of the insulin- responsive glucose transport protein GLUT-4, the importance of

exercise and diet in reversing aging processes, the role of dietary restriction on

glucoregulation, and the importance of an interplay between insulin resistance,

aging, and salt-sensitivity in contributing to high blood pressure in the elderly.

• Research was supported on the importance of advanced-glycosylation end

products (AGEs) in normative aging and in the development of vascular disease

(e.g., atherosclerosis), including the importance of renal function in AGE-related

vascular pathologies.
• The Institute supported research on the importance of insulin as a physiologic

regulator of human adrenal dehydroepiandrosterone metabolism as a possible

mechanism for the atherogenicity of hyperinsulinemia during aging.

Future plans:

• NIA will encourage investigator-initiated research focused on diabetes and aging.

• The NIA will provide supplemental support to the NIDDK-sponsored "Diabetes

Prevention Program (DPP)."

National Institute of Allergy and Infectious Diseases (NIAID)

The goal of research supported by the National Institute of Allergy and Infectious

Diseases (NIAID) in the area of autoimmune diseases, including insulin-dependent

diabetes mellitus, is to promote the application of information gained through basic

research in the biomedical sciences to the clinical investigation of the autoimmune

disease. The objectives are 1) to improve the understanding of the mechanisms that cause

the disease and 2) to design new and more effective preventive, diagnostic, and

therapeutic measures.

Recent Activities

• In collaboration with NIDDK and NICHD, NIAID is funding the multi-center

clinical trial Diabetes Prevention Trial-1 (DPT-1).

• NIAID served as the lead Institute sponsor of a scientific meeting on “Gender and

Autoimmunity” held on the NIH campus on September 28-29, 1995. The meeting

was co-sponsored by NIAMS, NIDDK, NINDS, and the ORWH, NIH.
• NIAID sponsored a workshop on “The Role of Infectious Agents in the

Development of Autoimmune and Immune-Mediated Diseases” on February 23-

24, 1995. Insulin- dependent diabetes mellitus has been associated with various

pathogens, and discussion of IDDM was a part of the workshop.

• NIAID recently funded grants received in response to an RFA for research into the

basic mechanisms of human immunotherapy trials. Several utilized patients

enrolled in the DPT-1. The NIDDK, NIAMS, and the ORWH joined NIAID in

supporting this initiative.

• NIAID issued an RFA for Interdisciplinary Programs in Autoimmunity to support

basic, molecular, immunologic, and genetic research into the pathogenesis of

autoimmune disease. The Juvenile Diabetes Foundation International and the

NIDDK are co-sponsors of this initiative.

• In collaboration with NIDDK and JDFI, NIAID funded several new diabetes

interdisciplinary research programs.

• NIAID supports contracts for isolation and characterization of MHC-bound selfpeptides in autoimmune disease. Several of these contracts contain specific

components related to IDDM.

Future Activities:

• NIAID intends to fund the most meritorious applicants from the Interdisciplinary

Programs in Autoimmunity RFA.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIAMS has nothing to report.

National Institute of Child Health and Human Development (NICHD)

The NICHD funds research on prevention of insulin-dependent and non-insulindependent diabetes mellitus as well as research on behavioral aspects of diabetes mellitus.

Much of the NICHD's diabetes research program focuses on gestational and neonatal

aspects of diabetes mellitus. The Institute supports one program project grant and two

Perinatal Emphasis Research Centers devoted to studying diabetes mellitus in pregnancy.

• Prediction of IDDM: The NICHD remains in the forefront of research on the

etiology and prevention of IDDM, focusing on the identification of antigens,

antibodies, and major histocompatibility loci on human chromosome 6 that are

linked to the pathogenesis of IDDM. A major research accomplishment was the

establishment of IDDM as an autoimmune disorder with a strong genetic

component. The NICHD is currently funding the largest, most comprehensive

study ever under taken of the natural history of IDDM. Recent results of this

study indicate that first-degree relatives of index cases of IDDM are at high risk of

becoming diabetic, especially if they share the same HLA Class II alleles.

• Diabetes Prevention Trial (DPT-l): Improved ability to identify persons at high

risk for IDDM led to the initiation of a large multicenter clinical trial aimed at

preventing the disease. The clinical trial is designed to delay or prevent the onset

of clinical diabetes in a group of first-degree relatives found by immunological
testing to be at high risk. This project will improve disease predictability and

clarify the pathological processes that underlie IDDM.

• Non-Insulin-Dependent Diabetes Primary Prevention Trial: The NICHD also

emphasizes research designed to prevent or delay the onset of NIDDM by

supporting two centers in a multicenter, randomized clinical trial (co-sponsored by

the NIDDK and the ORMH) to evaluate the efficacy of interventions designed to

delay or prevent onset of NIDDM in individuals at increased risk. These centers

focus on women who have had gestational diabetes mellitus (GDM), since more

than one-half of these individuals become clinically diabetic in the next 15 years.

• Diabetes in Pregnancy: Researchers are evaluating whether strict glycemic

control of diabetes prior to conception and throughout pregnancy will improve

pregnancy outcome by increasing the rate of conception, decreasing the incidence

of early pregnancy loss and major malformations, and decreasing the incidence of

maternal and neonatal complications, compared to moderate glycemic control.

This research promises improved therapy for diabetic women, which could lead to

pregnancy outcomes approaching those of the general population.

• Studies in Offspring of Diabetic Pregnancy: Childhood obesity is prevalent in

children of diabetic mothers; excessive nutrient transfer from mother to fetus may

lead to metabolic imprinting in utero. Obesity in children of diabetic mothers

appears to be related to high maternal insulin requirements and high plasma blood

glucose values during late pregnancy. These findings are striking and have

implications for early intervention strategies to prevent the occurrence of

metabolic abnormalities associated with insulin resistance in adulthood.
• Future Plans: The NICHD will continue to emphasize research on the prevention

of IDDM, NIDDM, and GDM. Studies on basic and clinical aspects of the

immunogenetics of IDDM and the immunomodulation of the immune system’s

attack on the pancreatic cells will be supported. Innovative therapy designed to

mitigate the immune system's attack on the cell will be encouraged. At the

molecular level, investigators can focus on elucidating how the antigen-presenting

cells that carry only certain kinds of class II alleles interact with cell proteins in

three-dimensional terms and how the antigen-presenting cells then interact with T

cells of the immune system to make them actively cytotoxic. The NICHD will

continue to fund program project research grants and Perinatal Emphasis

Research Centers devoted to determining the causes and consequences of IDDM

and NIDDM in pregnancy.

National Institute of Dental Research (NIDR)

The mission of NIDR is to support research on the causes, prevention, diagnosis and

treatment of oral and craniofacial diseases and conditions, including oral complications

associated with diabetes. These complications include greater prevalence and severity of

periodontal diseases, increased susceptibility to oral mucosal infections, salivary gland

dysfunction, and neuropathies resulting in loss or alteration of taste, smell, or mucosal

sensory perception. The NIDR also supports research on the effects of oral diseases and

conditions on diabetic metabolic control.
FY 95 Accomplishments

NIDR supported a variety of research projects involving diabetes.

• A study of the state of oral health in elderly and minority adults with diabetes.

• An investigation of the effects of maternal diabetes on the development of

craniofacial abnormalities.

• Research to determine the effects of diabetes-induced

hyperlipidemia/dyslipidemia on macrophage functions related to oral wound

healing.

• Participation in studies to determine 1) the frequency of painful diabetic

neuropathy and its associated health care costs and 2) the biological basis and

treatment of this disorder.

• Cloning and characterization of a gene, IA-2, that may be a target for autoimmune

destruction of pancreatic beta cells

• Investigation of possible treatment modalities for periodontal diseases in diabetic

Pima Indians.

Future Plans
• NIDR plans to organize a conference on the impact of diabetes on oral health and

how oral health components may affect the onset, prevention, and progression of

diabetes in living organisms.

• The Institute will continue to entertain investigator-initiated research applications

to study the oral complications of diabetes and the effects of oral diseases on

diabetic stability.

National Eye Institute (NEI)

The National Eye Institute’s (NEI’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 an

ocular disease, diabetic retinopathy, 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.

Highlights of Recent Activities

• Recent advances have been made in the identification and characterization of

growth factors that may play a role in abnormal retinal blood vessel proliferation

in diabetic retinopathy patients. Vascular endothelial growth factor (VEGF) is

present in greatly increased amounts in the ocular fluid of patients with retinal

neovascularization. Understanding the basic mechanism of action of VEGF may

be important for developing therapeutic strategies and agents for treating and

possibly preventing retinal neovascular diseases.
• Results on the 10-year incidence and progression of diabetic retinopathy obtained

from the Wisconsin Epidemiologic Study of Diabetic Retinopathy indicate that

patients whose diabetes was diagnosed before age 30 were at highest risk, of

developing diabetic retinopathy, those diagnosed at 30 or older were at

intermediate risk, and those not taking insulin were at the lowest risk. The high

incidence and progression of diabetic retinopathy during the 10-year study period

occurred despite advances in the treatment of insulin-dependent diabetes and

suggest a continued need for public and professional education on the

effectiveness of treatment in preserving vision.

• The “Diabetes in Early Pregnancy Study” examined the effects of pregnancy on

diabetic retinopathy. The study found that glucose control at the beginning of the

pregnancy was the most important factor associated with the progression of

retinopathy during pregnancy.

Future Activities

• Conduct and support basic research to gain a greater understanding of the

pathogenesis of diabetic retinopathy.

• Develop better methods of preventing, diagnosing, and treating diabetic

retinopathy.

• Continue cooperative efforts with the American Diabetes Association, through the

National Eye Health Education Program (NEHEP), to increase public awareness

of diabetes-related eye disease.
National Institute of General Medical Sciences (NIGMS)

The NIGMS supports research and research training in the basic biomedical sciences that

provide the foundation for a better understanding of fundamental life processes.

Knowledge resulting from this work contributes directly to the progress of research on

specific diseases, including diabetes. In addition, the NIGMS supports a major genetic

resource, the Human Genetic Mutant Cell Repository, which contains cell lines from

patients with a wide variety of genetic disorders and from normal controls. Cell lines in

the collection include those from individuals with various types of diabetes, including

insulin-dependent diabetes mellitus and diabetes mellitus and diabetes insipidus with

optic atrophy. 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 the disorder.

In 1995, the Repository provided researchers at universities throughout the U.S. with cell

cultures from patients with IDMM, maturity-onset diabetes in the young, diabetes

mellitus and diabetes insipidus with optic atrophy, and diabetes mellitus among the Pima

Indians.

National Heart, Lung, and Blood Institute (NHLBI)

No report.

National Institute of Neurological Disorders and Stroke (NINDS)

The NINDS is responsible for the conduct and support of diabetes-related research that

investigates the complications of diabetes in the peripheral and central nervous systems.

Major areas of research center on the understanding and treatment of diabetic neuropathy

and the role of diabetes as a risk factor for stroke.
Recent Accomplishments and Activities:

• NINDS grantees are working to understand the mechanisms by which high blood

sugar levels result in nerve damage. Investigators using animal models of diabetic

neuropathy have identified abnormalities of blood flow in nerves. Other studies

have shown higher levels of specific proteins in nerve samples from diabetic

patients both with and without polyneuropathy. Investigators are examining

whether glycation (the attachment of sugar molecules to proteins) may be

affecting blood protein levels.

• A long-term study of a group of people in Minnesota with diabetes has provided

information on the prevalence, severity, and characteristics of neuropathy in this

group.

Plans:

• Continuation of the epidemiologic study in Minnesota will further define the

course of neuropathy and also examine the influence of risk factors on outcome.

• The metabolic events identified in diabetic neuropathy have provided insights

into methods that may prevent or treat this disorder. Potential therapeutic agents

will continue to be evaluated in animal studies.

• Scientists will continue to investigate the relationship between diabetes and

stroke, including the role that high blood sugar levels may play in exacerbating

neuronal damage following stroke.

National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports and conducts research and

research training on the biological and behavioral processes that underlie promotion of

health, amelioration of illness and its sequelae, and effective delivery of care. One

purpose of this research is to understand how to promote health-sustaining behavior and

to improve quality of life by relieving the effects of disease processes and slowing their

progression. Nursing research focuses on how physical and psychological responses to

symptoms and treatment of disease affect health in the presence of specific diseases

throughout the lifespan. NINR research programs pay particular attention to vulnerable

populations, such as the very young, the very old, ethnic minorities, and the economically

and geographically disadvantaged. NINR's research interest in diabetes is to view it as a

model chronic condition whose onset and course can be modified substantially by factors

related to prevention, control, and self care. The following studies reflect grants in the

Institute’s portfolio related to diabetes:

• Focusing on the link between biological and behavioral factors in diabetic patients

with end-stage renal disease, NINR investigators are seeking to explain changes in

autonomic nervous system function that occur following kidney and pancreaskidney transplantation and the relationship of those changes to quality of life.

• Building on work indicating that intensive management improves diabetes

control, NINR is supporting investigators seeking to determine the relative effects

in metabolic control among youth aged 13 to 20 years of 1) a coping skills

training program implemented with intensive diabetes management 2) and

intensive management only. The study uses multiple physiological, behavioral,

and quality-of-life measures.

• The importance of family involvement in achieving adherence to treatment for

chronic illnesses seems to vary among population groups and by factors such as
age of family members. NINR is supporting a longitudinal study to determine the

differential effect of two intervention strategies targeted to community-residing

Black diabetic elders, one a patient-centered education/support intervention and

the other a family-centered intervention.

NINR will continue to collaborate with the National Institute of Diabetes, Digestive, and

Kidney Diseases, as it has in previous initiatives, on prevention and management of

diabetes in minority populations. NINR plans to continue our diabetes-related research

through investigator-initiated research and through our support of the National Diabetes

Education Program.

National Center for Research Resources (NCRR)

The National Center for Research Resources (NCRR) serves as a "catalyst for discovery"

by creating, developing, and providing a broad range of technologies and resources

necessary for investigators to conduct biomedical and behavioral investigations. This

research support is provided in four major areas: 1) Biomedical Technology, which

encompasses sophisticated technologies and shared instrumentation; 2) Comparative

Medicine, which supports resources for a variety of research models, including

mammalian and non-mammalian models as well as important biological materials

through the Regional Primate Research Centers and Biological Models and Materials

Research Program; 3) Clinical Research, including a network of General Clinical

Research Centers (GCRCs) that provide shared institutional resources for

multidisciplinary clinical research; and 4) Research Infrastructure, which supports

research facility construction and renovation and science education grants as well as

Research Centers in Minority Institutions.

Recent Activities in Diabetes Research
• Biomedical Technology: A collaborative study with an NCRR mass spectrometry

resource at Washington University in St. Louis and an NHLBI-supported

investigator demonstrated a link between imbalances in carnitine metabolism and

several abnormalities associated with diabetic polyneuropathy.

• Comparative Medicine: Researchers successfully allotransplanted isolated

pancreatic islet cells obtained from an NCRR-supported resource to diabetic

patients. Other research includes a study of cerebral blood flow and metabolism

in diabetic dogs and projects at the Regional Primate Research Centers exploring

metabolic processes in obesity and the regulation of insulin secretion.

• Clinical Research: The GCRCs support numerous investigations in diabetes.

Recent projects include 1) the use of insulin therapy in patients with anti-islet cell

antibodies to prevent the appearance of overt diabetes; 2) the differences in

glucoregulatory mechanisms and insulin metabolism between whites and African

Americans; 3) the presence of islet cell antibody to predict Type I diabetes in

school-age children; 4) the use of magnetic resonance spectroscopy to study

glycogen metabolism in diabetic and healthy subjects; and 5) the role of amylin

in the pathogenesis of carbohydrate metabolism.

Future Activities

The several programs within NCRR will continue to provide an array of multi-user

resources to investigators to attempt to prevent and further define the pathophysiology of

diabetes as well as to provide insight into alternative therapeutic approaches to minimize

or arrest the progress of this chronic disorder.
National Center for Human Genome Research (NCHGR)

No report.

Division of Research Grants (DRG)

The Metabolism Study section (MET), which is a study section within DRG, reviews a

very large number of applications in the diabetes area, including both type I and type II

diabetes. Dr. Krish Krishnan has been the Scientific Review Administrator of this study

section since 1986. MET makes an important contribution to DMICC activity because it

is entrusted with control of the quality of basic and clinical research in diabetes. In

general, diabetes research encompasses biochemical, molecular biological, and

physiological approaches. In basic research, animal models of diabetes, transgenics and

cultured cell systems are usually utilized. Highly qualified scientists from academia, the

pharmaceutical industry, and high-technology companies function as reviewers of the

applications.

The MET reviews investigator-initiated grant applications (r01) and First Award (R29s)

and fellowship (F32) applications. A “Summary Statement,” which is prepared after the

conclusion of the review meeting, includes the scientific comments of the various

reviewers and also reflects the crux of the meeting discussion. In addition, the summary

addresses whether the proposed research is of high risk and high impact. Such

information helps the NIDDK staff make an appropriate funding decision and to ensure

that tax payers’ money is supporting deserving research initiatives. Maintaining the

quality of diabetes research is critical to achieving advances in the diabetes area and will

contribute to finding new therapeutic strategies in the treatment of type II diabetes and

further advances in the management of type I diabetes.

Agency for Health Care Policy and Research (AHCPR)
No report.

Centers for Disease Control and Prevention (CDC)

No report.

National Center for Health Statistics (NCHS)

The National Center for Health Statistics is the Federal Government's principal vital and

health statistics agency. Data are collected from vital records, through personal

interviews and physical examinations, and from hospitals, nursing homes, and physician’s

office records. In addition, the NCHS has data on medical care utilization for persons

with diabetes treated in hospitals, physician's offices, and nursing homes. Mortality data

for diabetes mellitus from the national vital statistics system are based on information

reported on death certificates filed in all of the States.

Recent Accomplishments and Activities:

The NCHS has continuously collected data for diabetes mellitus and other causes of death

(including both underlying and multiple causes of death) and released these data in

various forms, including data tapes and the annual publication Vital Statistics of the

United States. The agency has published provisional diabetes mellitus mortality data in

the Monthly Vital Statistics Report.

NCHS has collected data on an ongoing basis through the National Health Care Survey,

which includes hospitalizations, visits to physician's offices, ambulatory surgery, and

visits to emergency and outpatient departments of short-stay hospitals for diabetes and its

complications. The survey also includes lengths of stay in nursing homes for persons

with diabetes and related conditions.
The agency has provided analytic and statistical support for the mid-course review of the

Healthy People 2000 objectives in priority area 22, Diabetes and other Chronic Disabling

Conditions.

Future Activities:

NCHS will, on an ongoing basis, collect and analyze diabetes-related information in its

major data collection systems.

The agency will perform analyses of data from the Third National Health and Nutrition

Examination Survey (NHANES III), including updated estimates of the prevalence of

diagnosed and undiagnosed diabetes in the US population based on oral glucose tolerance

tests administered to a representative national sample of the population.

Food and Drug Administration (FDA)

FDA did not approve any new anti-diabetic agents in 1995. Metformin was approved in

March 1994 for patients with Type II diabetes mellitus, and reports continue to confirm

the added benefits of Metformin either as monotherapy or in conjunction with other antidiabetic agents on the market. Similarly, efforts continue nationwide to enroll Type II

(NIDDM) patients in clinical trials to test the “generalizability” of the DICCT study with

Type I (IDDM) patients.

FDA continues to work actively with several pharmaceutical firms on nasal insulin and

insulin analogs that may improve the control of hyperglycemia. Phase III studies are

currently under way with the implanted programmable pump, with intraperitoneal insulin

infusion resulting in 70-85% of administered insulin entering hepatic circulation,

mimicking physiological in vivo insulin delivery. Other related activities include the

development of anti-obesity agents. The FDA's Metabolism and Endocrine Drugs
Advisory Committee recommended approval of dexfenfluramine; by a 6 to 5 vote, the

Committee concluded that dexfenfluramine's benefit to obese persons outweighed its

potential risks. FDA is currently considering other additional/ pertinent data before

reaching a decision.

Health Resources and Services Administration (HRSA)

The Health Resources and Services Administration manages a number of health care

systems development programs, none specific to diabetes. However, all include elements

of diabetes education, prevention, recognition, or treatment, as appropriate.

• The Bureau of Primary Health Care funds approximately 500 community and

migrant health clinic programs, operates the National Health Service Corps and

associated scholarship and loan repayment programs, and manages several health

programs for special populations. All clinical programs include appropriate

diabetes screening and treatment. The National Hansen's Disease Center has

special expertise in management of Hansen's-related foot pathology; it has

adapted its treatments to diabetes and developed the Lower Extremity Amputation

Prevention (LEAP) program. This program has been incorporated into a national

campaign linked to the Healthy People 2000 goal of reducing amputations by

40%. LEAP materials have been provided to the American Diabetes Association

for its Foot Seminars; to all Veterans Administration medical centers, all Indian

Health Service facilities, and all Community, Migrant, Rural, and Homeless

Health Centers; and to large numbers of diabetes professionals and educators.

Distribution of these materials has been transferred to the NIH Diabetes Outreach

Program.
• The Maternal and Child Health Bureau (MCHB) administers MCH Block Grants

to States to support maternal and child health programs. It also administers a

program of discretionary grants for Special Projects of Regional And National

Significance. MCHB is committed to appropriate care for diabetes in its maternal

and child populations within existing primary care systems, with special emphasis

on community systems of care. MCHB's Healthy Start Initiative, designed to

reduce infant mortality by 50 percent in targeted communities, includes services

addressing diabetes in mothers and in children. Services for children and youth

with diabetes are included as part of Title V services systems development for all

children with special health care needs. The MCH Block Grant includes attention

to children with special health care needs, including diabetes care or case

management. MCHB disseminates information on screening for childhood

diabetes and implements programs for diabetes care. MCHB also promotes

diabetes detection and care through school-based and school-linked health

programs and through programs that provide primary health care to incarcerated

youth.

• The Bureau of Health Professions administers several programs supporting health

professions education, none specific to diabetes. However, most include diabetes

education, particularly primary care practitioner training programs and continuing

education programs such as those supported by Area Health Education Centers

and Geriatric Education Centers.

• The Bureau of Health Resources Development supports the Organ Procurement

and Transplantation Network and Scientific Registry. Among its services are

support of pancreas and combined pancreas-kidney transplants; most of the

500-800 such transplants each year are for the treatment of diabetes.
Indian Health Service (IHS)

The Indian Health Services’s goal is to foster collaborative strategies for primary,

secondary, and tertiary prevention in all IHS/tribal/urban facilities through a network of

19 model projects and area diabetes coordinators. The IHS seeks to reach patients,

providers, and community leaders with current information about all aspects of diabetes

prevention.

FY 95 Highlights:

• The yearly IHS Diabetes Care Audit measured levels of glycemic control and key

variables related to diabetes standards of care. Over 8,000 medical records for

person with NlDDM were randomly audited to estimate the level of diabetes care

for 50,000 diabetic patients receiving primary health care in IHS or tribal health

facilities. Summary reports were generated immediately to be available to the

facility's staff for quality improvement activities and program planning. Data

from participating sites are now being combined and analyzed to determine

regional and national rates.

• The "Evaluation of Services Provided by IHS Model Diabetes Program" report

was published. Factors associated with improved glycemic control included

medical nutrition therapy by a registered dietitian in the first year after diagnosis,

an HgCA1c test performed one or more times in two years, and receiving foot

care in the first year after diagnosis.

• The Diabetes Program worked with NIDDK to develop a Southwest Indian Center

to participate in the NIDDK multicenter trial to prevent NIDDM; it also worked in

the NHLBI Pathways feasibility study of obesity prevention in Native American

children.
• The IHS participated in the nationwide distribution of over 17,000 patient and

health provider diabetes education materials. Diabetes nutrition education print

materials for Native Americans were developed, extensively field tested, and

distributed nationwide.

Veterans Health Administration (VHA)

Diabetes affects 15-20% of VHA inpatients; about 14% of veterans receiving ambulatory

care receive oral hypoglycemic agents or insulin. The VHA recognizes that complications

such as amputation, visual loss, and end-stage renal disease can be largely prevented

and/or forestalled by a multidisciplinary health care team approach in combination with

patient-centered self- management. The VHA’s mission relative to diabetes and health

reform is to decrease the prevalence of adverse health outcomes in veterans with diabetes

by ensuring that every patient has access to prevention and treatment programs that meet

national standards of care.

FY 95 Accomplishments and Activities:

• Patient Education: MultiVISN Continuous Quality Improvement Program for

Diabetes Patient Education and Treatment: Eleven VA medical centers have

achieved ADA recognition in FY 1996, for a total of 14 in 46 medical centers and

outpatient clinics in the Northeast (region I). Overall, the VA has 20 ADArecognized programs, significantly more than in HMO medical centers and other

Federal agencies. The program was extended through FY 96.

• Foot Care: (i) National Prevention Amputation Care and Treatment Program

(Rehabilitation Medicine and Prosthetics and Sensory Aids Services) training

program for about 60 medical centers (April 1995): Our goal was to have medical
centers form disciplinary care teams that would address foot care for all patients

at risk, beginning with prevention and identification through post-amputation

care. Pending funding, remaining programs are scheduled to receive training in

1996. A total of 140/171 VA medical centers are expected to develop teams. (ii)

The VA was a lead agency, in collaboration with the National Diabetes Outreach

Program and other Federal agencies, in establishing a National Foot Care

Awareness Program. Pending funding, a nationwide VA teleconference on the

role of primary care providers in foot screening and care is planned.(iii) A

computerized data base for foot risk stratification patients with diabetes

underwent pilot testing (validation) at nine VA medical centers (10/95-12/95).

• Quality Assurance: (i) Monitors for Diabetic Ketoacidosis (External Peer Review

Process ongoing); (ii) Monitors for outpatient management of diabetes (External

Peer Review Program initiated 2/95); (iii) Development of a quality indicator of

care for annual use of glycated hemoglobin levels (national reporting); (iv)

Standardization of glycated hemoglobin reporting (VA National Center for Cost

Containment; VANCLAS; Diabetes Advisory Field Group; Laboratory and

Medical Services); (v) Diabetes Costing Project: 120,000+ patients identified as

receiving oral hypoglycemic agents or insulin will have diabetes- related

pharmacy costs, resource utilization, and laboratory usage evaluated (VA

National Center for Cost Containment, VACO Pharmacy Service, Diabetes

Advisory Field Group).

FY 96 Initiatives:

• Juvenile Diabetes Foundation/VA Research Partnership: $3 million annually for

5 years to fund Diabetes Research Centers.
• Develop Diabetes Advisory Field Group position statements on self-bloodglucose Monitoring and use of hemoglobin A1C for glycemic control.

• Standardize glycated hemoglobin levels (VA National Center for Laboratory

Accuracy and Standardization).

• Pilot testing of computerized encounter forms.

• Formal report: Prevalence-based cost analysis of diabetes in the VA (National

Center for Cost Containment).
Appendix A

DMICC Legislative Authority
Appendix B

Roster of DMICC Members
02/07/1996

Diabetes Mellitus Interagency Coordinating Committee

MEMBERSHIP ROSTER

Chairman

Richard Eastman, M.D.

Director, Division of Diabetes,

 Endocrinology, and Metabolic Diseases

National Institute of Diabetes

 and Digestive and Kidney Diseases

National Institutes of Health

Building 31, Room 9A16

31 Center Drive, MSC 2560

Bethesda, MD 20892-2560

Phone: (301) 496-7348

FAX: (301) 496-2830

Email: eastmanr@hq.niddk.nih.gov

Agency for Health Care Policy

 and Research

Center for Medical Effectiveness

Research

2101 East Jefferson Street, Suite 605

Rockville, MD 20852

Phone: (301) 594-1485

FAX: (301) 594-3211

Susan J. Blumenthal, M.D., M.P.A.

Deputy Assistant Secretary for Health

 (Women's Health)

Assistant Surgeon General

Office of Women's Health

Department of Health and Human

Services

Hubert Humphrey Building, Room 730B

200 Independence Avenue, S.W.

Washington, DC 20201

Phone: (202) 690-7650

FAX: (202) 401-4005

F. J. Brinley, Jr., M.D., Ph.D.

Director, Division of Convulsive,

 Developmental, and Neuromuscular

 Disorders

National Institute of Neurological

 Disorders and Stroke

National Institutes of Health

Federal Building, Room 816

7550 Wisconsin Avenue

Bethesda, MD 20892-9160

Phone: (301) 496-6541

FAX: (301) 402-0302
Centers for Disease Control and

Prevention

Maryland Diabetes Control Program

Division of Diabetes Translation

201 West Preston Street

Baltimore, MD 21201

Phone: (410) 225-6774

FAX: (410) 333-7279

Elaine Collier, M.D.

Chief, Autoimmunity Section

Clinical Immunology Branch

Division of Allergy, Immunology,

 and Transplantation

National Institute of Allergy

 and Infectious Diseases

Solar Building, Room 4A20

6003 Executive Boulevard, MSC 7640

Bethesda, MD 20892-7640

Phone: (301) 496-7104

FAX: (301) 402-2571

Email: ec5x@nih.gov

Michael P. Davis, M.S.

Associate Director for Science Policy

 and Legislation

National Eye Institute

National Institutes of Health

Building 31, Room 6A23

31 Center Drive, MSC 2510

Bethesda, MD 20892-2510

Phone: (301) 496-4308

FAX: (301) 402-3799

Email: mpd@b31.nci.nih.gov

Katherine M. Flegal, Ph.D.

Chief, Medical Statistics Branch

National Center for Health Statistics

Centers for Disease Control and

Prevention

6525 Belcrest Road, Room 900

Hyattsville, MD 20782

Phone: (301) 436-7075 x202

FAX: (301) 436-3436

Email: kmf2@nch09a.em.cdc.gov

Julia B. Freeman, Ph.D.

Centers Program Director

Director, Women's and Minority Health

 Issues

National Institute of Arthritis

 and Musculoskeletal and Skin Diseases

National Institutes of Health

Natcher Building, Room 5AS-49F

45 Center Drive, MSC 6500

Bethesda, MD 20892-6500

Phone: (301) 594-5052

FAX: (301) 480-4543

Dorothy Gohdes, M.D.

Director, Indian Health Services

Diabetes

 Program

Indian Health Service (HQ West)

5300 Homestead Road, N.E.

Albuquerque, NM 87120

Phone: (505) 837-4182

FAX: (505) 837-4188

Harriet Gordon, M.D.

Medical Officer, Clinical Research

National Center for Research Resources

National Institutes of Health

One Rockledge Centre, Room 6030

6705 Rockledge Drive, MSC 7965

Bethesda, MD 20892-7965

Phone: (301) 435-0790

FAX: (301) 480-3661

Email: harrietg@ep.ncrr.nih.gov

Gilman D. Grave, M.D.

Chief, Endocrinology, Nutrition,

 and Growth Branch

Center for Research for Mothers

 and Children

National Institute of Child Health

 and Human Development

Executive Building 6100, Room 4B11

6100 Executive Boulevard, MSC 7510

Bethesda, MD 20892-7510

Phone: (301) 496-5593

FAX: (301) 402-2085

Email: ggu@cu.nih.gov
Judith H. Greenberg, Ph.D.

Division Director

Genetics and Developmental Biology

 Program Branch

National Institute of General Medical

 Sciences

Natcher Building, Room 2AS-19H

45 Center Drive, MSC 6200

Bethesda, MD 20892-6200

Phone: (301) 594-0943

FAX: (301) 480-2228

Maureen Harris, Ph.D.

Director, Diabetes Research Section

Division of Diabetes, Endocrinology,

 and Metabolic Diseases

National Institute of Diabetes

 and Digestive and Kidney Diseases

Natcher Building, Room 5AN-24E

45 Center Drive, MSC 6600

Bethesda, MD 20892-6600

Phone: (301) 594-8801

FAX: (301) 480-3503

Richard Kahn, Ph.D.

Chief Scientific and Medical Officer

American Diabetes Association

1660 Duke Street

Alexandria, VA 22307

Phone: (703) 299-2065

FAX: (703) 836-7439

Email: rkahn@diabetes.org

N. Krish Krishnan, Ph.D.

Scientific Review Administrator

Metabolism Study Section

Division of Research Grants

Two Rockledge Centre, Room 4122

6701 Rockledge Drive, MSC 7818

Bethesda, MD 20892-7818

Phone: (301) 435-1779

FAX: (301) 480-2644

Email: k4k@.drgpo.drg.nih.gov

John Lanigan

Professional Affairs Advisor

Health Care Financing Administration

Hubert Humphrey Building, Room 435H

200 Independence Avenue, S.W.

Washington, DC 20201

Phone: (202) 690-7418

FAX: (202) 401-7438

Louis Emmet Mahoney, M.D.,

Dr.P.H.

Medical Consultant

Health Resources and Services

 Administration

Parklawn Building, Room 14-39

5600 Fishers Lane

Rockville, MD 20857

Phone: (301) 443-0458

FAX: (301) 443-2605

Email: lmahoney@hrsa.ssw.dhhs.gov

Dennis Mangan, Ph.D.

Director, Periodontal Diseases Program

National Institute of Dental Research

Natcher Building, Room 4AN-32F

45 Center Drive, MSC 6402

Bethesda, MD 20892-6402

Phone: (301) 594-2421

FAX: (301) 480-8318

Email: manganD@de45.nidr.nih.gov

Dr. Patricia Moritz

Acting Director, Division of Extramural

 Research

National Institute of Nursing Research

Building 45, Room 3AN-12

45 Center Drive, MSC 6300

Bethesda, MD 20892-6300

Phone: (301) 594-5966

FAX: (301) 480-8260

Email: pmoritz@ep.ninr.nih.gov
National Center for Human

Genome

 Research

National Institutes of Health

Building 38A, Room B2N13

38 Library Drive, MSC 6050

Bethesda, MD 20892-6050

Phone: (301) 402-2205

FAX: (301) 402-2218

Leonard Pogach, M.D.

Program Director, Diabetes

Diabetes Education and Treatment

Center

Veterans Affairs Medical Center

Veterans Health Administration

385 Tremont Avenue

East Orange, NJ 07019-1095

Phone: (201) 676-1000 x1693

FAX: (201) 677-4408

Andre J. Premen, Ph.D.

Director

Cardiovascular Aging Program

Geriatrics Program

National Institute on Aging

Gateway Building, Room 3E327

7201 Wisconsin Avenue, MSC 9205

Bethesda, MD 20892-9205

Phone: (301) 496-6761

FAX: (301) 402-1784

Email: premena@gw.nia.gov

David M. Robinson, Ph.D.

Director, Vascular Research Program

National Heart, Lung, and Blood

Institute

Two Rockledge Centre, Room 10193

6701 Rockledge Drive, MSC 7956

Bethesda, MD 20892-7956

Phone: (301) 435-0545

FAX: (301) 480-2849

Email: robinsod@gwgate.nhlbi.nih.gov

Shiao-Wei Shen, M.D.

Medical Officer, Division of Metabolism

 and Endocrinology

Food and Drug Administration

Parklawn Building, Room 14B-04

5600 Fishers Lane, HFD-510

Rockville, MD 20857

Phone: (301) 443-3520

FAX: (301) 443-9282

Executive Secretary

Sanford Garfield, Ph.D.

Director, Diabetes Special Programs

Division of Diabetes, Endocrinology,

 and Metabolic Diseases

National Institute of Diabetes

 and Digestive and Kidney Diseases

Natcher Building, Room 5AN-24B

45 Center Drive, MSC 6600

Bethesda, MD 20892 6600

Phone: (301) 594-8807

FAX: (301) 480-3503