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Overview: More Americans than ever before are suffering from diabetes, with the number of new cases averaging almost 800,000 each year. The disease has steadily increased in the United States since 1980, and in 1998, 16 million Americans were diagnosed with diabetes (10.3 million diagnosed; 5.4 million undiagnosed). Diabetes is the seventh leading cause of death in the United States, and more than 193,000 died from the disease and its related complications in 1996. Diabetes is a chronic disease that has no known cure.

According to new research published by the Centers for Disease Control and Prevention (CDC), the prevalence of diabetes in adults, including gestational diabetes, increased 33 percent during the 1990s. The greatest increase - 76 percent - occurred in people age 30 to 39. Increases encompass all demographic groups and nearly every state in the U.S. In particular, diabetes among American Indians and Alaska Natives populations is increasing in epidemic proportions. According to HHS' Indian Health Service (HIS), diabetes mortality is 2.8 to 4.3 times higher in American Indians and Alaskan Natives than in the general U.S. population.

To combat this serious illness, Health and Human Services Secretary Donna E. Shalala launched Healthy People 2010 in January 2000, a set of broad-based national health goals used to track the nation's health in targeted areas, including obesity and physical activity. In addition, HHS is making significant strides in improving diabetes care and treatment through a number of ongoing activities at its agencies. The department's Racial and Ethnic Health Disparities Initiative seeks to eliminate health inequities suffered by racial and ethnic minority groups in six key areas, including diabetes. Healthy People 2010 has set high national health goals for all Americans, ending a practice of separate, lower goals for racial and ethnic minorities. To help reach these ambitious targets, HHS will mobilize the resources and expertise of the federal government, the private sector, and local communities.

The CDC and the National Institutes of Health (NIH) also co-sponsor the department's National Diabetes Education Program (NDEP), a joint initiative designed to improve diabetes treatment and outcomes, promote early diagnosis and to prevent the onset of diabetes. The NDEP also develops educational tools and community-based interventions and establishes public and private sector partnerships to address the needs of people with diabetes and raise general awareness about the disease.

For fiscal year 2001, the President's budget includes $54 million for CDC's National Diabetes Control Program and $561 million for expanded research within NIH, an increase of $36 million from the previous year.

Background:

What is Diabetes -- Diabetes is one of the most expensive health problems in the United States, and it can lead to many other health problems. The American Diabetes Association estimates that $98.2 billion was spent in 1997 on diabetes care ($44.1 in costs directly attributable to diabetes and $54.1 billion for indirect medical costs, such as work loss, disability, and premature death.) Diabetes is a disease in which the body does not produce or properly use insulin, a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. The cause of diabetes is a mystery, although both genetics and environmental factors such as obesity and lack of exercise do play roles. There are three major types of diabetes:

• Type 1, formerly known as insulin-dependent diabetes mellitus or juvenile-onset diabetes, most often occurring in children and young adults. People with Type 1 diabetes must take daily insulin injections to stay alive. Type 1 diabetes accounts for 5-10 percent of all diabetes in the United States.

• Type 2, formerly known as non-insulin-dependent diabetes mellitus or adult-onset diabetes, is a disorder resulting from the body's inability to make enough, or properly use, insulin. It is the most common form of the disease, accounting for 90-95 percent of diabetes.

• Gestational Diabetes develops in 2 percent to 5 percent of all pregnancies, but usually disappears when the pregnancy is over. Women who have had gestational diabetes have a greater risk of developing Type 2 diabetes later in their lives.

The Diabetes Profile--Among Americans aged 65 and older, 6.3 million persons (18.4 percent of this age group) have diabetes; among those aged 20 and older, 15.6 million (8.2 percent of all Americans 20 and over) have the disease. Many ethnic minority populations are especially impacted by the disease. Prevalence of diabetes by ethnic group includes:

• Non-Hispanic whites: 11.3 million (7.8 percent of those aged 20 and older)
• Non-Hispanic African-Americans: 2.3 million (10.8 percent)
• Mexican Americans: 1.2 million (10.6 percent)
• Other Hispanic/Latino Americans: On average, almost twice as likely to have diabetes as non-Hispanic whites of similar age. (Data insufficient for more specific estimate for 1997)
• American Indians and Alaska Natives: 112,000 (12.2 percent of the federally recognized tribal population aged 20 and older. Those with diabetes range from 7 percent to 50 percent among individual tribes). From 1990 to 1997, There has been an alarming 32 percent increase in diabetes among American Indian and Alaska Native youth aged 15 to 19, a 36 percent increase in young adults aged 20 to 24, and a 28 percent increase in adults aged 25 to 34.
• Cuban Americans: On average, almost twice as likely to have diabetes as the general population.

NEW NATIONAL INITIATIVES

The Department of Health and Human Services is carrying out several diabetes initiatives as part of programs created in the Balanced Budget Act of 1997 and in response to the President's Initiative on Race. Diabetes is one of the six disease areas that were targeted by the department's disparities elimination initiative:

Healthy People 2010 Targets Diabetes-In January 2000, Secretary Shalala launched Healthy People 2010, a set of broad-based national health goals for the entire country. Targeting several areas including obesity and physical activity, Healthy People 2010 aims to reduce the disease and economic burden of diabetes, and improve the quality of life for all persons who have or are at risk for diabetes. Six objectives were developed to help meet the national challenge: diabetes education; the burden of disease (new, existing and undiagnosed diabetes, death, pregnancy complications); marcrovascular, microvascular and metabolic complications; laboratory services; health provider services; and diabetes management behaviors.

Indian Health Service (IHS) National Diabetes Program-The IHS National Diabetes Program aims to develop, document and sustain a public health effort to prevent and control diabetes in American Indian and Alaska Native peoples. The agency promotes collaborative strategies for the prevention of diabetes and its complications through a network of 19 Model Diabetes Programs, services that provide state-of-the-art, comprehensive clinical diabetes care to individuals, families and communities. The IHS also distributes current information about all aspects of diabetes surveillance, treatment, education and prevention. In addition, the Balanced Budget Act of 1997 provided $150 million over five years to IHS for the establishment of a Grants for Special Diabetes Program for Indians. Grant development included the full participation of tribes, tribal leaders, urban Indian organizations and IHS staff, and ultimately awarded grants to 318 programs under 286 administrative organizations with IHS.

HHS' Eliminating Racial and Ethnic Health Disparities Initiative-In order to set the stage for the elimination of diabetes disparities experienced by racial and ethnic minority groups by the year 2010, HHS will rely on two established Healthy People 2000 benchmarks: reducing the rate of kidney disease from diabetes among blacks and American Indians/Alaska Natives by 65 percent from their 1995 levels by the year 2000, and reducing lower extremity amputation rates from diabetes among blacks by 40 percent from their 1995 levels. The department started this initiative by making sure that current programs focus on opportunities to reduce health disparities and highlight the best scientific and community-derived knowledge about how to deliver effective clinical and preventive services. In addition, the department will provide a national framework for public and private sector collaboration to eliminate health disparities through Healthy People 2010-the nation's health action agenda for the 21st century.

Diabetes Quality Improvement Program-The Diabetes Quality Improvement Program (DQIP) is a coalition that includes HCFA, CDC, the American Diabetes Association, the National Committee for Quality Assurance, as well as other public and private health care organizations. The DQIP employs two sets of measures - accountability and quality improvement - that allows key components of diabetes care to be compared within and across health care settings as a basis for quality improvement.

Expanded Medicare Coverage for Diabetes Treatment- Beginning in July of 1998, all Medicare Part B and Medicare managed care enrollees with diabetes received Medicare coverage for all blood glucose testing supplies. Under the new policy, all people with diabetes enrolled in Medicare Part B or Medicare managed care received affordable coverage of blood glucose monitors, test, strips and lancets. Blood glucose testing is currently the only method available for patients with diabetes to monitor blood sugar levels and make necessary day-to-day changes in the self-management of the disease. In order for Medicare enrollees to receive these benefits, a physician must prescribe the supplies and document on the prescription how often self-monitoring is required.

ONGOING DIABETES ACTIVITIES AT HHS:

The National Diabetes Education Program with CDC and NIH-The National Diabetes Education Program (NDEP) is cosponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health and the Division of Diabetes Translation of the Centers for Disease Control and Prevention. Launched in mid-1997, the goal of the NDEP is to reduce the illness and numbers of deaths associated with diabetes and its complications, and to raise the same awareness for diabetes as has been done for hypertension and cholesterol in the past. Since public awareness about diabetes is very low, the first goal of the NDEP is to inform people with diabetes as well as the general public about its complications and to stress that diabetes is a serious, common, and costly disease, yet it is controllable. Through partnerships with multiple public and private organizations, the NDEP conducts ongoing diabetes awareness and education activities, develops and disseminates educational tools and resources, and promotes initiatives to improve the quality of and access to diabetes care. On June 23, 1998, NDEP kicked off the "Control Your Diabetes. For Life." program to encourage the 16 million Americans with diabetes to control their blood sugar levels.

Additional CDC Diabetes Programs - CDC also operates a National Diabetes Laboratory (NDL) to support emerging scientific efforts on Type 1 diabetes. Researchers are working to identify the genetic and immunologic risk factors associated with diabetes, developing more precise medical instrumentation, and providing people with user-friendly equipment to monitor blood glucose levels.

CDC also funds diabetes control programs in all 50 states, the District of Columbia, and eight U.S.-affiliated jurisdictions. The programs strive to improve access to affordable, high-quality diabetes care and services, with priority on reaching high-risk and disproportionately affected populations.

The National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - NIDDK's research mission focuses on diabetes as well as other metabolic, digestive, kidney, urologic and blood diseases. Basic and clinical research programs in diabetes target the genetic, biologic and environmental factors that contribute to diabetes and its complications. NIDDK supports two major prevention trials in diabetes: the Diabetes Prevention Program, which seeks to determine whether Type 2 diabetes can be prevented or delayed in people with insulin resistance and impaired glucose tolerance, and a condition in which blood glucose levels are higher than normal but not yet diabetic. The study compares an intensive program of diet and exercise versus treatment with metformin, a diabetes medication. About 45 percent of the 3,000 DDP participants are minorities. For more information about the DPP, see "NIDDK-funded trials" at www.niddk.nih.gov/.

A separate NIDDK-supported multicenter trial, the Diabetes Prevention Trial-Type 1, is testing whether insulin injections or oral insulin can prevent Type 1 diabetes in high-risk individuals - people who have close relatives with Type 1 diabetes and high levels of islet cell antibodies. For more information about this trial, call 1-800-HALT-DM1 or see "NIDDK-funded trials" at www.niddk.nih.gov/.

For more than 30 years, NIDDK scientists have been studying Type 2 diabetes in Arizona's Pima Indians, a population that has the highest reported prevalence of Type 2 in the world. Results of these studies have helped to define the role of various risk factors in the natural history of the disease. Researchers have recently identified a gene that affects the age of onset of Type 2 diabetes in the Pimas. Another newly identified gene raises the risk of developing the kidney disease of diabetes in the Pima population.

Other NIH components, including the National Heart, Lung and Blood Institute, the National Eye Institute, the National Center for Research Resources; and the National Institute of Child Health and Human Development, conduct and support research in diabetes.

The Indian Health Service (IHS) - The fiscal year 2000 budget for IHS includes a total of $41 million for diabetes activities for American Indians and Alaska Natives, primarily for prevention of the most serious consequences of diabetes, such as amputation, blindness and organ failure. Collaborative strategies involving federal, tribal, and urban facilities have been fostered through a network of area diabetes control officers and 19 model projects funded specifically by congressional action. This infrastructure is coordinated by a technical support center-- a clearinghouse, which provides current information about successful primary, secondary, and tertiary prevention at the community level.

The Agency for Healthcare Research and Quality (AHRQ) - AHRQ supports research that evaluates the cost effectiveness, outcomes, and appropriateness of different clinical approaches to specific diseases or conditions, including diagnostic tests, and medical and surgical procedures. AHRQ is using two teams of researchers to develop comprehensive, longitudinal databases, and to examine variations in the management and outcomes of care for diabetes patients. The first team will develop methodology essential to the assessment of the effectiveness of medical care for Type 2 diabetes. The second team will focus on the impact of choices in the management of dialysis for patients with End-Stage Renal Disease (ESRD) on clinical, functional, and economic outcomes. Diabetes is the primary attributable cause of ESRD in nearly 30 percent of all cases. AHRQ is also supporting research projects that are developing diabetes educational interventions and exploring ways to reduce the complications of diabetes.

The Health Resources and Services Administration (HRSA) - Diabetes outreach, health education and treatment services are provided through the nations' network of health centers supported by HRSA's Bureau of Primary Health Care (BPHC). These health ceners serve 10 million persons at more that 3,000 sites around the country. BPHC's Models that Work (MTW) competition identifies programs with exemplary records of achievement and shares that information with communities that face similar problems. A 1998 Models that Work winner, the School Health Outreach Program of Sunset Park Family Health Center Network, has demonstrated improved diabetes management for children enrolled in their school health program.

BPHC also developed the Lower Extremity Amputation Prevention (LEAP) program at the National Hansen's Disease Center and has continued to collaborate with other organizations to increase the use of LEAP techniques by persons with diabetes.

HRSA's BPHC is supporting five Health Status and Performance Improvement Collaboratives. Focused on diabetes treatment and management, the Collaboratives create learning opportunities for the staffs from over 100 BPHC delivery sites across the country. Teams from each participating health center, in coordination with HRSA Field Office staff, Primary Care Associations and Clinical Networks, join in a 6-12 month learning experience that provides guidance and instruction for improving performance in diabetes management. The learning process combines scientific theory with organizational change methodology to result in improvements in health outcomes, system efficiency, patient and provider satisfaction, and access, while reducing cost and inappropriate utilization of services.

HRSA's Maternal and Child Health Bureau (MCHB) allows diabetes to be addressed in a variety of ways through the Title V Block Grant Program to 59 states, jurisdictions and discretionary grant programs. Having identified diabetes as a risk factor in women of child bearing age and as a risk factor in fetal/infant mortality, particularly among racial and ethnic minority populations, the MCHB Block Grant has helped create several community-specific initiatives to incorporate culturally and linguistically competent approaches to diabetes education and prevention.

The Health Care Financing Administration (HCFA) - The Health Care Financing Administration has selected diabetes as a clinical focus area for the Peer Review Organizations (PRO) for the quality improvement for the 3-year contract cycle, which started in 1999. Each PRO will be working on statewide improvement in test rates for Hemoglobin A1c lipid testing, and eye exams and may choose to work on improvement in areas related to other measures. PROs will also be working collaboratively with hundreds of other providers in their states to improve care for Medicare beneficiaries. In addition, HCFA has launched national quality improvement initiatives designed to improve eye exam rates, reduce blindness and curb amputation rates. HCFA is working with various partners to understand and reduce geographic and racial disparities through activities which are part of the peer review program.

The Food and Drug Administration (FDA)- FDA has taken steps that make it possible for people with diabetes to maintain better control of their disease. In the early 1990's, the agency, along with the U.S. Department of Agriculture, put in place food labeling regulations that, among other things, require labels of most packaged food to provide more complete nutrition information. People with diabetes can learn about the nutritional content of almost all the food they eat.

More recently, FDA has approved a fast-acting form of human insulin and several new oral diabetes drugs that improve sensitivity to insulin. These drugs are designed to help Type 2 diabetics make better use of the insulin produced by their bodies. FDA also regulates blood glucose monitors. For millions of Americans with diabetes, regular home testing of blood glucose levels is critical in controlling their disease. These tests give an idea of how well a person's diabetes management plan is working. In June 1999, FDA approved a new type of glucose monitor that continuously measures tissue glucose levels in adults with diabetes for up to three days. The information obtained from this new device, helps doctors adjust their patient's therapies.

The Office of Public Health and Science (OPHS) - The HHS OPHS Office of Minority Health, in partnership with the CDC, has funded cooperative agreements with national minority organizations such as the National Council of La Raza, the Association of Asian Pacific Community Health Organizations and the Association of American Indian Physicians to conduct diabetes activities.

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