TWENTY-FIRST ANNUAL REPORT OF THE

DIABETES MELLITUS INTERAGENCY COORDINATING

COMMITTEE

FISCAL YEAR 1994

Richard C. Eastman, M.D.

Chairman
TABLE OF CONTENTS

Introduction 1

Legislative Mandate 1

Activities of the DMICC 1

Activities of Member Organizations 2

National Institutes of Health

National Institute of Diabetes

 and Digestive and Kidney Diseases 2

National Institute on Aging 5

National Institute of Allergy

 and Infectious Diseases 6

National Institute of Child Health

 and Human Development 6

National Institute of Dental Research 7

National Eye Institute 7

National Institute of General

 Medical Sciences 7

National Heart, Lung, and Blood Institute 8

National Institute of Neurological

 Disorders and Stroke8

National Institute of Nursing Research 8

National Center for Research Resources 9

National Center for Human Genome Research 9
Division of Research Grants 9

Agency for Health Care Policy and Research10

Centers for Disease Control and Prevention 10

National Center for Health Statistics 11

Food and Drug Administration 11

Health Resources and Services Administration 12

Indian Health Service 13

Veterans Health Administration 13

Appendix A: DMICC Legislative Authority 15

Appendix B: Roster of DMICC Members 18

Appendix C: Fiscal Year 1994 Diabetes-Related Expenditures 23
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) 1994.

LEGISLATIVE MANDATE

The DMICC was authorized by Public Law 93-354 and was 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 1994, 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 1994 is presented in

Appendix C.

In FY 1994, the DMICC held four meetings and 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 pursuing

projects that focus on bringing together indepth information from the varied programs

represented by the member organizations; being the catalyst for the initiation of projects;

and guiding the progress of projects involving several agencies.

ACTIVITIES OF MEMBER ORGANIZATIONS

In its role as a facilitator in the collection and dissemination of information about Federal

activities related to diabetes mellitus, the DMICC is pleased to present the following

summary of diabetes-related activities reported by organizations represented on the

DMICC.

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

The NIDDK is the lead agency of the Federal Government for research efforts to combat

diabetes mellitus and its complications. The Institute conducts and supports research and

research training related to a broad array of diseases that are characterized by chronicity

and long-term disabling effects. The NIDDK's Division of Diabetes, Endocrinology, and

Metabolic Diseases has responsibility for extramural programs related to diabetes

research. Additional diabetes-related activities are supported by the Institute's divisions

of Intramural Research; Digestive Diseases and Nutrition; and Kidney, Urologic, and

Hematologic Diseases.

Diabetes is the sixth leading cause of death from disease in the United States. It afflicts

an estimated 13 to 14 million people, but approximately one-half of these cases are

undiagnosed. It is also the leading cause of new adult blindness, kidney failure, and

nontraumatic amputation and is a major risk factor for stroke, heart attack, and premature

death. The annual economic cost of diabetes to the Nation is estimated to be $91-$105

billion in medical care and lost productivity. In addition, minority populations, including

African Americans, Hispanics, Native Americans, Hawaiians, and Alaska Natives, are

disproportionately affected by diabetes and by its enormous cost burden.

Research Accomplishments

The NIDDK supports a wide range of fundamental and clinical studies related to the

etiology, pathogenesis, prevention, diagnosis, treatment, and cure of diabetes and its

complications. Recent research advances include the following:

 Research has uncovered evidence that an environmental factor, coxsackie virus,

may be involved in the initiation of insulin-dependent diabetes mellitus (IDDM).
 The drug troglitazone has been found to reduce elevated blood glucose and insulin

concentrations in diabetic animals and humans and to improve the two conditions

that give rise to noninsulin-dependent diabetes mellitus (NIDDM)—impaired

glucose tolerance and insulin resistance—and hypertension in obese, but not yet

diabetic, individuals.

 Research has identified the molecular defect that causes insulin resistance in

animals.

 A gene was discovered whose overexpression is unique to the skeletal muscle

tissue of individuals with NIDDM. Skeletal muscle is the major site of insulin

resistance in the diabetic and prediabetic patient. Overexpression of this gene

may be responsible for the aberrant regulation of glucose processing that gives

rise to NIDDM.

 Antibody tests have been developed that can identify individuals at high risk for

developing IDDM.

 An antihypertensive medication has been found to slow the progression of

diabetic kidney disease.

Program Initiatives

Diabetes Prevention and Treatment Initiative (DPTI): To investigate methods of

preventing and treating diabetes, the NIDDK has begun a new, comprehensive initiative

targeted at preventing diabetes and its complications. The DPTI encompasses basic and

applied research, clinical trials, and national multicenter clinical trials. New strategies for

the prevention of diabetes will encompass ethnically diverse and multiracial patient

populations. An important element of the DPTI is a national multicenter clinical trial for

the prevention of IDDM. The trial will investigate whether intervention prior to clinical

onset of IDDM can delay the disease in first-degree relatives of individuals with

established IDDM. At-risk individuals will be treated either with low-dose insulin

injections or with oral insulin administration. Because IDDM is considered an

autoimmune disease, these approaches are anticipated to “immunize” the at-risk

individuals against self-destruction of their insulin-secreting pancreas cells. This trial is

expected to run 5 years.

A second important element of the DPTI is a clinical trial of intervention strategies to

prevent the onset of NIDDM in people with impaired glucose tolerance or gestational

diabetes mellitus who are at high risk for developing the disease. NIDDM

disproportionately impacts minority populations, who accordingly will make up 50

percent of the study population in order to ensure applicability of the results to these

groups. Pharmacologic and lifestyle interventions, such as those targeting diet and

exercise, are being evaluated for inclusion in this study. The trial is a collaborative effort
between the NIDDK, the National Institute of Child Health and Human Development,

and the NIH Office of Research on Minority Health and is scheduled to last 7 years.

National Diabetes Outreach Program (NDOP): Results announced in 1993 of the

NIDDK's landmark DCCT showed that very careful management of blood glucose levels

dramatically reduces the risk of life-threatening microvascular complications—eye,

kidney, and nerve damage—due to diabetes. Following release of the DCCT results, it

was apparent that these findings could have profound implications for the life-long

health, and quality of life, for insulin-dependent diabetics. Thus, the NIDDK has initiated

efforts designed to disseminate, evaluate, and investigate these results. Early in FY 1995,

the Institute launched the NDOP to help disseminate the results of the DCCT to patients,

health care professionals, and the general public regarding the importance of controlling

blood sugar levels. The Institute's Division of Diabetes, Endocrinology, and Metabolic

Diseases and National Diabetes Information Clearinghouse are collaborating with

voluntary health organizations, the private sector, and other Federal agencies to address

the issues surrounding dissemination of the DCCT results to the diabetes community and

to people at risk for developing IDDM.

Search for Diabetes Genes: Genetics appears to be the common denominator underlying

the various factors that lead to diabetes. Intensified genetics research offers great promise

for understanding, controlling, and preventing diabetes. The NIDDK continues to

enhance support for both the basic understanding of diabetes and the direct application of

this knowledge to the clinic.

Diabetes in Minority Populations: Research has shown that the most prominent risk

factors for NIDDM are a family history of diabetes, obesity, insulin resistance,

hyperinsulinemia, history of gestational diabetes, and impaired glucose tolerance.

African Americans, Hispanics, and Native Americans are disproportionately affected.

The U.S. Congress and the Department of Health and Human Services have highlighted

the growing problem of diabetes in minority populations as important public health issues

deserving increased research effort.

In addition to the DPTI, another component of the NIDDK's diabetes prevention effort in

minority populations is the Institute's program initiative entitled “Intervention Studies in

Diabetes Among Minority Populations,” which will broaden understanding of the cause,

course, diagnosis, treatment, cure, and prevention of NIDDM and its complications

among African Americans, Asian Americans, Hispanics, and Native Americans as well as

Alaska Natives, Pacific Islanders, and Native Hawaiians.

The NIDDK and the NIH Office of Research on Minority Health are collaborating on a

clinical study of the development of NIDDM in Mexican-American women. The aim of

the study is to identify early metabolic defects in Mexican-American women who are at

high risk for NIDDM because of prior NIDDM associated with pregnancy. In future
studies, these early defects may be targeted for interventions aimed at delaying or

preventing the onset of NIDDM.

Kidney Disease of Diabetes Mellitus (KDDM): KDDM is the single most frequent cause

of end-stage renal disease. Several avenues of research are therefore approaching the

problem of how KDDM develops and how it might be arrested before serious kidney

damage occurs.

Urologic Complications of Diabetes Mellitus (UDDM): Although the prevalence of

UDDM is undetermined, physicians have long recognized that diabetics have a high

incidence of urinary incontinence, urinary tract infection, and erectile impotence. Just as

diabetes affects the development of these disorders, the disorders can have a significant

impact on the metabolic regulation of diabetes and patient compliance with diabetes

treatment.

Future Plans

The NIDDK has developed program initiatives in diabetes where significant scientific

opportunities exist. These initiatives include expansion of clinical trials to prevent

diabetes, research on the genetics of diabetes, methods for achieving euglycemia in

diabetics, expansion of fundamental diabetes research, research on the prevention and

treatment of complications from diabetes, and research on the relationship of obesity to

diabetes.

National Institute on Aging (NIA)

Recent diabetes-related research support includes the following:

 Mechanisms by which glucose intolerance and insulin resistance develop with

advancing age, including studies on insulin-responsive glucose transport systems,

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

on glucoregulation.

 Role of advanced glycosylation endproducts (AGEs) in the pathogenesis of

vascular disease in the elderly, including cloning, sequencing, and regulation of

expression of AGE-receptor binding unit genes, and the importance of AGEendothelial cell interactions in promoting development of age and diabetes-related

vascular pathologies.

 Role of chemical pathways of the Maillard reaction under physiologic conditions

as a basis for hyperglycemic-induced aging.

 Investigation of reasons for lack of compliance with medical regimens in a rural

Native American population with a high incidence of NIDDM.
 Importance of glucose abnormalities on memory performance and glucoregulatory

hormone levels in the elderly.

 Conduct of a retrospective study of NIDDM in the elderly and hospitalization

rates as a basis for support that greater demands for health care services will

accompany increased longevity as a result of higher levels of age-specific

morbidity.

 Importance of interplay among aging, sympathetic nervous system function,

insulin resistance, and salt sensitivity in contributing to hypertension in the

elderly.

 Role of insulin as a physiologic regulator of human androgen (adrenal

dehydroepiandrosterone) metabolism as a possible mechanism for the

atherogenicity of hyperinsulinemia in humans.

National Institute of Allergy and Infectious Diseases (NIAID)

Recent diabetes-related activities include the following:

 An RFA issued for research into the basic mechanisms of human immunotherapy

trials, including the Diabetes Prevention Trial-1 (DPT-1). This initiative, which is

also supported by the NIDDK, the NIAMS, and the ORWH, will use patients

already enrolled in clinical trials to investigate the basic mechanisms of

autoimmune diseases.

 A recently announced RFA, cosponsored with the Juvenile Diabetes Foundation

International (JDFI) and the NIDDK, for Interdisciplinary Programs in

Autoimmunity to support basic, molecular, immunologic, and genetic research

into the pathogenesis of autoimmune disease.

 Collaboration with NIDDK and NICHD on the DPT-1.

 Funding of four program project grants to study the pathogenesis of autoimmune

disease by the combined effort of basic and clinical researchers. Several of these

programs have components studying IDDM.

 An RFA released in collaboration with NIDDK and JDFI for additional Diabetes

Interdisciplinary Research Programs. This request for program project applications is intended to foster an interdisciplinary approach to diabetes research with

the application of the most recent advances in basic molecular biology, genetics,

cell biology, immunology, and biophysics.

National Institute of Child Health and Human Development (NICHD)
The NICHD funds research on prevention of both IDDM and NIDDM in addition to

funding research on behavioral aspects of diabetes mellitus, particularly studies of

compliance in adolescents with IDDM. Much of the NICHD research program on

diabetes is concerned with research on gestational and neonatal aspects of diabetes

mellitus. The Institute supports more than half a dozen diabetes-related research efforts:

Insulin-Dependent Diabetes Mellitus (IDDM); In Vitro Expression of the Insulin Gene;

Prediction of IDDM (the preeminent accomplishment of this programmatic activity has

been to establish that IDDM is an autoimmune disorder with a strong genetic

component); Diabetes Prevention Trial (DPT-1); Noninsulin-Dependent Diabetes Primary

Prevention Trial; Diabetes in Pregnancy; Studies in Offspring of Diabetic Pregnancy; and

Perinatal Studies of Disorders of Fetal Metabolism. In addition, the NICHD currently

supports one program project grant and two Perinatal Emphasis Research Centers that are

devoted to the study of diabetes mellitus in pregnancy.

National Institute of Dental Research (NIDR)

Recent diabetes-related accomplishments include the following:

 The establishment of the National Oral Health Information Clearinghouse to

disseminate information to special populations with high risk for oral disease.

One such group is diabetics, who have increased incidence and severity of

periodontal diseases, mucosal infections, salivary dysfunction, and oral

neuropathies including burning mouth syndrome.

 The release of an RFA in July 1994, in collaboration with the NIDDK, entitled

“Research on Periodontal Complications of Diabetes.” One purpose of this

initiative is to encourage collaborative research by clinicians and basic scientists

to better define the pathogenesis of periodontal diseases associated with both type

1 and type 2 diabetes. Another purpose is to further our understanding of the

effects of periodontitis on glucose metabolism in diabetics. The applications are

to be reviewed in March 1995.

National Eye Institute (NEI)

In 1994, NEI involvement in diabetes-related activities has been in the areas of basement

membrane biochemistry and biology, advances in aldose reductase research, and

epidemiology of diabetic retinopathy. NEI's National Eye Health Education Program

(NEHEP) has expanded its efforts to reach people at risk for diabetic eye disease. These

efforts include the distribution of NEHEP education kits that are directed to individuals

who are responsible for educating people at risk for diabetic eye disease. The NEHEP

staff also is monitoring the progress of three applied research projects on diabetic eye

disease education and providing technical assistance in the development of health

education materials.

The ADA and the NEI are jointly conducting an awareness campaign on diabetic eye

disease for National Diabetes Month. Nine other NEHEP partnership organizations have
offered their support to increase the public's awareness about the importance of annual

dilated eye examinations for diabetics and will coordinate local activities. An extensive

media campaign that included a video news release, press release, print advertisements,

and a radio program targeted to radio stations with a predominantly African American

audience was conducted to augment local efforts.

National Institute of General Medical Sciences (NIGMS)

In addition to other activities, the NIGMS supports a significant genetic resource, the

Human Genetic Mutant Cell Repository. The repository contains cell lines from normal

controls as well as from patients with a wide variety of genetic disorders such as those

from individuals with various types of diabetes, including IDDM and diabetes mellitus

and insipidus with optic atrophy. In 1994, the repository provided researchers at

universities throughout the United States with cell cultures from patients with IDMM,

maturity onset diabetes in the young, diabetes mellitus and insipidus with optic atrophy,

and diabetes mellitus of the Pima Indians.

Among the diabetes-related research projects supported by the NIGMS are studies of the

regulation of insulin gene expression; the transport of proteins, including insulin, within

the cell; protein secretion by the cell; the structure and function of receptors for insulin

and other proteins; basic metabolic processes at the cellular and molecular levels; and the

effect of severe trauma and disease on glucose metabolism and insulin resistance.

National Heart, Lung, and Blood Institute (NHLBI)

In 1994, the NHLBI funded numerous studies that investigate issues relevant to diabetes:

“Insulin, Androgen and Risk in African-American Women”; “Mechanism of Reduced

Endothelium-Dependent Relaxation Diabetic Blood Vessels”; “High Blood Sugar

Potentiates the Constrictor Effects of Protein Kinase C in Arteries”; “Adhesion Molecules

and Atheroma in Rabbits”; “Genetics of Diabetes”; “Effect of Diabetes on Short- and

Long-Term Mortality of Acute Myocardial Infarction”; “High Glucose Reduces Basic

Fibroblast Growth Factor-Induced In Vitro Angiogenesis: Implications for Vascular

Impairment in Diabetes Mellitus”; “Acculturation and Diabetes”; “Abdominal Fat Is a

Strong Risk Factor for Abdominal Diabetes”; and “Distribution of Insulin Sensitivity in

Three Ethnic Groups.”

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.

NINDS-supported diabetes-related research conducted in 1994 included the following

studies: “Epidemiology of Diabetic Neuropathy”; “Diagnosis of Diabetic Neuropathy”;

“Pathogenesis of Diabetic Neuropathy”; “Diabetes as a Stroke Risk Factor“; “Neural

Mechanisms of Peripheral Pain in Diabetes”; and “Treatment of Diabetic Neuropathy.”
National Institute of Nursing Research (NINR)

NINR's research interests in diabetes concern factors related to prevention and control.

The following studies reflect grants in their 1994 portfolio:

 Attention to the link between biological and behavioral factors is critical in order

to deal with clinical problems experienced by diabetic patients having kidney

transplants. NINR investigators are determining these biobehavioral factors

responsible for improved quality of life following pancreas-kidney and kidneyonly transplant.

 A two-phased longitudinal study is examining parent and family system

adaptation to the care of a chronically ill child, using a family stress and coping

framework. In the second phase, comparisons will be made between 90 families

who have a child with diabetes mellitus and 90 families who have a child with

congenital heart disease.

 A pilot study of a low-impact exercise intervention for women with NIDDM is

being supported within an exploratory center's grant targeted to studies of fatigue

management. This study examines the effect of exercise on fatigue, activity

levels, and metabolic control in these women.

 A longitudinal, randomized study is comparing a patient-centered

education/support intervention among community-residing elderly black diabetics

with a family-centered intervention.

National Center for Research Resources (NCRR)

NCRR diabetes-related investigations conducted in 1994 included the following:

“Decreased Polymorphonuclear Leukocyte (PMN) Deformability in NoninsulinDependent Diabetes Mellitus (NIDDM)”; “Improvement in Glucose Tolerance and

Insulin Resistance in Obese Subjects Treated with Troglitazone”; “Assessment of Insulin

Action and Glucose Effectiveness in Diabetic and Nondiabetic Humans”; “13C-Nuclear

Magnetic Resonance Spectroscopy of Hepatic Glucose Metabolism in Normal Subjects

and Subjects with Insulin-Dependent Diabetes Mellitus (IDDM)”; “Control of Cerebral

Vasculature in Diabetic Dogs”; “Caloric Restriction and Aging in Nonhuman Primates”;

“Evidence for Superantigen Involvement in the Onset of IDDM”; “D-Chiro-Inositol and

Diabetes Mellitus”; and “Role of Sorbitol Dehydrogenase in Mediating Sorbitol PathwayLinked Vascular Dysfunction Induced by Diabetes.”

National Center for Human Genome Research (NCHGR)

The Laboratory of Gene Transfer in the Intramural Research Program of the NCHGR is

seeking to locate the genes for a number of different human genetic disorders and to study

their function once they have been successfully identified. A new and ambitious effort is
to identify the major loci predisposing an individual to adult-onset diabetes. For this

purpose, in 1994, the Intramural Research Program entered into a collaborative project

with researchers in Finland to explore the complex genetics of NIDDM. Because

NIDDM appears to result from the interaction of one or more genes with environmental

factors, the NCHGR is interested in studying it as a model for analyzing the genetics of

common diseases. This project includes the participation of patients and researchers in

Finland as well as three research centers in the United States, the NCHGR, the University

of Southern California, and the University of Michigan.

Division of Research Grants (DRG)

The Metabolism Study Section (MET), a study section within NIH's DRG, reviews most

of the applications in the diabetes area. These applications address both type 1 and type 2

diabetes. The contribution of DRG to DMICC activity lies in the pivotal role entrusted to

the study section, which is the control of the quality of diabetes research in the areas of
metabolism and endocrinology. The types of applications reviewed are the investigatorinitiated grant applications (R01) and the First Awards (R29).

Applications are reviewed by highly qualified scientists from academia and the

pharmaceutical industry. After a meeting where experts review the application, a

Summary Statement is prepared that includes the scientific comments of the various

reviewers and the highlights of the meeting discussion regarding the application as well

as addresses the proposed research with regard to potential risk and impact. This

information serves to assist the NIDDK in making appropriate research funding decisions

and ensures that taxpayer dollars are adequately diverted to the support of diabetes

research.

Agency for Health Care Policy and Research (AHCPR)

AHCPR's Medical Treatment Effectiveness Program (MEDTEP) funded the following

diabetes-related activities in 1994: a Diabetes Patient Outcomes Research Team; several

R01 grants in which diabetes prevention, screening, treatment, or management are

addressed; and four AHCPR MEDTEP Research Centers on Minority Populations

engaged in diabetes research.

Centers for Disease Control and Prevention (CDC)

In 1994, CDC's Division of Diabetes Translation addressed its congressionally assigned

responsibilities as follows:

 The Division continued to develop and refine diabetes surveillance at the national

and State levels, encouraging the States to utilize the diabetes module of the

Behavioral Risk Factor Survey as a primary surveillance tool.

 CDC completed qualitative evaluation of Take Charge of Your Diabetes: A

Guide for Care and Encarguese de su Diabetes: Una Guia Para su Cuidado, the

English and Spanish versions of a manual designed to assist persons with diabetes

to become active members of their own care teams. Also, CDC expanded efforts

to implement Diabetes Today, a program designed to train health care providers

and others in the mobilization of community resources for diabetes prevention and

control programs.

 CDC completed the pilot phase of project DIRECT (Diabetes Intervention:

Reaching and Educating Communities Together), a community intervention

demonstration in which important diabetes research findings ready for translation

will be put into practice.

 CDC's state-based program to reduce the burden of diabetes focuses attention on

the changing opportunities and responsibilities of public health agencies in
improving the capacity of the health system to reduce the burden of diabetes. In

FY 94, CDC
supported diabetes control programs in 42 states and 5 territories through direct

headquarters operations, onsite technical assistance, and financial assistance.

 In addition to its activities with the DMICC, CDC continued working closely with

its Technical Advisory Committee for Diabetes Translation and Control Programs

and others to coordinate diabetes translation activities at the national level.

National Center for Health Statistics (NCHS)

The following information reflects recent accomplishments and activities of the NCHS:

 Continuous collection of data for diabetes mellitus and other causes of death for

both underlying and multiple causes of death and release of these data in various

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

United States, as well as publication of provisional diabetes mellitus mortality

data in the Monthly Vital Statistics Report.

 Ongoing collection of data in the National Health Care Survey on hospitalizations,

ambulatory visits to physicians' offices, ambulatory surgery and visits to

emergency and outpatient departments of short stay hospitals for diabetes and its

complications, and lengths of stay in nursing homes for persons with diabetes and

related conditions.

 Ongoing analytic and statistical support to the lead agencies for the Healthy

People 2000 objectives in priority area 22—Diabetes and Other Chronic Disabling

Conditions.

 Continuing data collection in the third National Health and Nutrition Examination

Survey (NHANES III), including questions on diabetes, an oral glucose tolerance

test, measurements of glycated hemoglobin, insulin and C-peptide, and retinal

photography.

 Data collection on levels of ability and disability in the National Health Interview

Survey for 1994 that includes information on diabetes among both the disabled

and the nondisabled population.

 Manuscripts published, submitted for publication, or in press include “An

Analysis of Increased Diabetes Mortality Rates 1980-1989”; “The Frequency and

Determinants of Screening for Diabetes in the U.S., Based on NHIS Data”; and

“Sociodemographic Characteristics of Persons with Diabetes” (for Diabetes in

America).

Food and Drug Administration (FDA)
In March 1994, an FDA advisory committee voted unanimously to recommend that FDA

approve metformin for patients with type 2 diabetes who cannot achieve adequate blood

sugar control with diet alone. At this meeting, the president of the ADA urged approval

of metformin as a safe and effective drug that controls blood glucose by mechanisms

different from mechanisms of currently available drugs. Currently approved and

marketed antidiabetic drugs work by stimulating the pancreas to secrete more insulin.

Metformin increases the body's response to its own insulin. Unlike the other drugs,

metformin rarely causes hypoglycemia and generally does not cause weight gain. It may

cause temporary anorexia (loss of appetite), abdominal discomfort, or nausea. It can be

used together with currently available oral antidiabetic drugs.

Metformin, to be sold under the trade name Glucophage, has been approved in about 80

countries and has never been withdrawn for safety reasons. The manufacturer, Lipha

Pharmaceuticals Company, will conduct an educational campaign to inform health

professionals and patients about the drug's risks and benefits and appropriate precautions.

The company will also conduct a postmarketing study in 10,000 patients to increase

knowledge about potential safety problems.

Health Resources and Services Administration (HRSA)

HRSA's Bureau of Primary Health Care's (BPHC) Division of Community and Migrant

Health has developed plans to determine the extent of diabetes mellitus in the populations

served by Community/Migrant Health Centers. The following are two recent activities

involving diabetes mellitus:

 The implementation of clinical outcome measures, which include specific

assessment of cardiovascular risk factors in relation to diabetes mellitus in the

adult life cycle, functional assessment of mobility and cause of impairment,

immunization status, and medication assessment in the geriatric life cycle. These

measures are important for the identification and treatment of diabetes mellitus.

 The use of the Primary Care Effectiveness Review, a site visit tool containing

specific questions related to diabetes mellitus. These include protocols and

quality assurance items.

Some Community/Migrant Health Centers continue to work with the CDC or Diabetes

Training Centers to upgrade their ability to treat diabetes mellitus. Several are currently

assessing how to deliver enhanced services and better care to people with diabetes.

Programs include the Comprehensive Perinatal Care Program; the Health Care for the

Homeless Programs; and the National Hansen's Disease Program (NHDP), which began

national distribution of its Lower Extremity Amputation Prevention (LEAP) Program

Information Kit to health care providers in December 1993. (LEAP is a simple and

effective program designed to identify patients with diabetes who are at risk for

developing plantar ulcers, which can lead to foot amputation.) In addition, in

collaboration with the NHDP, BPHC has developed a Diabetic Foot Care Program Five-
Year Strategy in prevention, treatment, training, and evaluation to reduce lower extremity

amputations associated with diabetes.

HRSA's Division of Organ Transplantation maintains the national Organ Procurement

and Transplantation Network and Scientific Registry under contract with the United

Network for Organ Sharing. The most common indication for a pancreas transplant is

diabetes mellitus. As of December 1, 1994, 222 patients were waiting for a pancreas

transplant, and 1,066 patients were waiting for a combined pancreas-kidney transplant.

The Maternal and Child Health Bureau of HRSA is committed to full, appropriate care

for diabetes in its maternal and child populations within existing primary care systems.

Special emphasis is on developing systems of care at the community level. Diabetesrelated activities include the Healthy Start Initiative and ongoing collaborative efforts

with States to disseminate, review, and implement programs for diabetes care as stated in

the Public Health Guidelines for Enhancing Diabetes Control Through Maternal and

Child Health Programs.

Indian Health Service (IHS)

Recent IHS diabetes-related activities include the following highlights:

 A nursing orientation package for diabetes in American Indians was developed

and distributed.

 Diabetes prevention posters that address particular complications, which were

developed by an Indian artist and extensively field tested, were printed and

distributed.

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

to participate in the NIDDK multicenter trial to prevent type 2 Diabetes.

 The Assessment of Diabetes Care measured levels of glycemia on the charts of

8,000 people representing 49,000 diabetic patients receiving care in IHS or tribal

facilities. Twenty-seven percent of patients experienced glycemic control

approximately comparable to the intensive group of the Diabetes Control and

Complications Trial.

Veterans Health Administration (VHA)

Recent diabetes-related accomplishments and activities include the following efforts:

 Encouraging formal patient education programs and formal hospital diabetes

committees at all VHA Medical Centers, such as the 1-week national training

program held for multidisciplinary teams from all 59 unaffiliated Department of
Veterans Affairs Medical Centers and the Continuous Quality Improvement

Program for Diabetes Patient Education and Treatment. This program involved

46 medical centers and outpatient clinics in the Northeast and was sponsored in

collaboration with the Regional Medical Education Center's 2-day

conference/workshop, to provide training for Diabetes Program Coordinators in

developing programs that meet NDAB national standards for patient education.

 Preventing lower extremity complications. These efforts are exemplified by the

designation of diabetes-related lower extremity amputation as a key clinical

indicator; the establishment of a national policy (based on a directive from the

Undersecretary of Health, issued in July 1993) for the formation of

multidisciplinary foot care teams under the direction of the Director of the Deputy

Chief Medical Director for Rehabilitation and Prosthetics; and an increase in the

number of funded podiatry residencies from 79 to 142, as a result of increased

congressional appropriations that were earmarked for current podiatric residency

programs.

 Monitoring quality of care. These efforts include the establishment of quality

assurance monitors for the diabetic ketoacidosis; establishment of ancillary

laboratory committees to monitor compliance with quality assurance guidelines

for glucose monitoring; and analysis of patient-specific ambulatory care use of

glycated hemoglobin levels.
Appendix A

DMICC Legislative Authority
Appendix B

Roster of DMICC Members
Appendix B

12/16/94

Diabetes Mellitus Interagency Coordinating Committee

MEMBERSHIP ROSTER

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

Floyd J. Brinley, M.D., Ph.D.

Director

Division of Convulsive, Developmental,

and Neuromuscular Disorders

National Institute of Neurological

Disorders and Stroke

Federal Building, Room 816

7550 Wisconsin Avenue

Bethesda, MD 20892-9165

Phone: (301) 496-6541

FAX: (301) 402-0302

James F. Coan, Jr.

Senior Public Health Advisor

Maryland Diabetes Control Program

Division of Diabetes Translation

Centers for Disease Control and

Prevention

201 West Preston Street

Baltimore, MD 21201

Phone: (410) 225-6774

FAX: (410) 333-7279

Elaine Collier, M.D.

Chief, Autoimmunity Section

 of the Clinical Immunology Branch

Division of Allergy, Immunology,

 and Transplantation

National Institute of Allergy and

Infectious Diseases

Solar Building, Room 4A20

6003 Executive Boulevard

Rockville, MD 20852

Phone: (301) 496-7104

FAX: (301) 402-2571

Shirley H. Clark, M.M.H.

Health Scientist Administrator

Center for Medical Effectiveness

Research

Agency for Health Care Policy

 and Research

2101 East Jefferson Street, Suite 605

Rockville, MD 20852

Phone: (301) 594-1485

FAX: (301) 594-3211
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

Katherine M. Flegal, Ph.D., M.P.H.

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

Julia B. Freeman, Ph.D.

Centers Program Director

Director

Women's and Minority Health Issues

National Institute of Arthritis

 and Musculoskeletal and Skin Diseases

Natcher Building, Room 5AS-49F

45 Center Drive, MSC 6500

Bethesda, MD 20892-6500

Phone: (301) 594-5052

FAX: (301) 480-4543

Harriet L. Gordon, M.D.

Medical Officer

General Clinical Research Centers

Program

National Center for Research Resources

Westwood Building, Room 10A-03

5333 Westbard Avenue

Bethesda, MD 20892

Phone: (301) 594-7945

FAX: (301) 594-7929

Dorothy Gohdes, M.D., F.A.C.P.

Program Director, Diabetes Program

Indian Health Service

5300 Homestead Road, N.E.

Albuquerque, NM 87110

Phone: (505) 837-4182

FAX: (505) 837-4188

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

Building 61E, Room 4B11

6100 Executive Boulevard

Rockville, MD 20852

Phone: (301) 496-5593

FAX: (301) 402-2085

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 22314

Phone: (703) 549-1500 x209

FAX: (703) 836-7439

Krish Krishnan, Ph.D.

Scientific Review Administrator

Metabolism Study Section

Division of Research Grants

Westwood Building, Room 207

5333 Westbard Avenue

Bethesda, MD 20892

Phone: (301) 594-7156

FAX: (301) 594-8687

John P. Lanigan

Director, Division of Professional

 and Business Affairs

Health Care Financing Administration

Hubert Humphrey Building, Room 403B

200 Independence Avenue, S.W.

Washington, DC 20201

Phone: (202) 690-6616

FAX: (202) 401-7438

Mary Lucas Leveck, R.N., Ph.D.

Chief, Acute and Chronic Illness Branch

National Institute of Nursing Research

Natcher Building, Room 3AN-12

45 Center Drive, MSC 6300

Bethesda, MD 20892-6300

Phone: (301) 594-5963

FAX: (301) 480-8260

Louis E. Mahoney, M.D., Dr.P.H.

Medical Consultant to Chief Medical

Officer

Office of the Administrator

Health Resources and Services

Administration

Parklawn Building, Room 14-39

5600 Fishers Lane

Rockville, MD 20857

Phone: (301) 443-0458

FAX: (301) 443-2605

Dennis Mangan, Ph.D.

Director, Periodontal Diseases Program

National Institute of Dental Research

Natcher Building, Room 4AN-321

45 Center Drive, MSC 6402

Bethesda, MD 20892-6402

Phone: (301) 594-2421

FAX: (301) 480-8318

Leonard M. Pogach, M.D.

Program Director for Diabetes

Department of 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.

Program Director

Cardiovascular/Pulmonary/Renal/Nutriti

on/ Metabolism/Gastroenterology

Geriatrics Program

National Institute on Aging

Gateway Building, Room 3E327

7201 Wisconsin Avenue

Bethesda, MD 20892-9205

Phone: (301) 496-6761

FAX: (301) 402-1784

David M. Robinson, Ph.D.

Director, Vascular Research Program

National Heart, Lung, and Blood

Institute

Federal Building, Room 416

7550 Wisconsin Avenue

Bethesda, MD 20892

Phone: (301) 496-5656

FAX: (301) 402-3508

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

Helen Simon

Chief, Office of Program Planning

 and Legislation

National Center for Human Genome

Research

Building 38A, Room B2N13

38 Library Drive, MSC 6050

Bethesda, MD 20892-6050

Phone: (301) 402-2205

FAX: (301) 402-2218

Frank Vinicor, M.D., M.P.H.

Director, Division of Diabetes

Translation

Centers for Disease Control and

Prevention

Mail Stop K10

4770 Buford Highway, N.E.

Atlanta, GA 30341-3724

Phone: (404) 488-5000

FAX: (404) 488-5966

Chairman

Richard Eastman, M.D.

Director, Division of Diabetes,

Endocrinology, and Metabolic Diseases

National Institute of Diabetes

 and Digestive and Kidney Diseases

Building 31, Room 9A16

31 Center Drive, MSC 2560

Bethesda, MD 20892-2560

Phone: (301) 496-7348

FAX: (301) 496-2830

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) 594-8803

FAX: (301) 480-3503
Appendix C

Fiscal Year 1994 Expenditures for Diabetes
Appendix C

DIABETES-RELATED EXPENDITURES BY AGENCY

FISCAL YEAR 1994

National Institutes of Health (dollars in thousands)

National Institute of Diabetes

 and Digestive and Kidney Diseases 191,409

National Cancer Institute 1,279

National Heart, Lung, and Blood Institute 19,779

National Institute of Dental Research 2,505

National Institute of Neurological Disorders

 and Stroke 5,717

National Institute of Allergy

 and Infectious Diseases 4,898

National Institute of General Medical Sciences 1,704

National Institute of Child Health and

 Human Development 12,329

National Eye Institute 22,605

National Institute of Environmental Health Sciences 415

National Institute on Aging 6,666

National Institute of Mental Health 2,036

National Institute on Alcohol Abuse

 and Alcoholism 329

National Center for Research Resources 18,577

National Institute for Nursing Research 1,130

National Center for Human Genome Research 2,181

Fogarty International Center 56

Total, NIH 293,615

Other Federal Agencies

Centers for Disease Control and Prevention 18,410

Agency for Health Care Policy and Research1,210

Indian Health Service 6,883

Total, PHS 26,503

Total for NIH and PHS 320,118

PLEASE NOTE: This table excludes AREA awards.