Diabetes Research in the Department of Veterans Affairs

The focus of Clinical Science Research and Development is to support clinical research that is relevant to veterans. The most visible component is the Cooperative Studies Program. The VA conducts population-based research through clinical trials on health issues that are vital to our nation’s veterans. Through multisite randomized trials, VA researchers are investigating strategies to improve the effectiveness of treatment provided to persons with diabetes. Some current examples in the diabetes portfolio include studies of innovative models for diabetes care, evaluating the short-term consequences of screening for diabetes, and investigating the use of fluorescent scatter on the lens of the eye as a possible tool for diagnosing diabetes. A cooperative study is now underway using intensive versus conventional insulin treatment to manage glycemia in veterans with type 2 diabetes. This study examines the issues of expected benefits and costs and cardiovascular disease outcomes.

Other funding mechanisms are used to support peer-reviewed research, specialized centers of excellence, and training. The Epidemiologic Research and Information Centers (ERICs) conduct diabetes and other research, education, and technical assistance and disseminate relevant findings to research and clinical communities.

Between 1998 and 2002, the VA with cofunding from the Juvenile Diabetes Foundation International, created three VA diabetes research centers located in Iowa City, Nashville, and San Diego. The Iowa City focus was the identification of potential causes of early vascular defects and design of preventive or palliative therapies. The Nashville center emphasized the cellular and molecular processes by which intensive therapy reduced insulin resistance and the role of exercise in modulating therapeutic effectiveness. The San Diego center concentrated on insulin resistance mechanisms and causes of diabetic vascular and renal complications.

Biomedical Laboratory Research and Development supports investigator-initiated research to study basic biological or physiological principles related to disorders and diseases of importance to veterans. Funded programs may use human tissues, blood, or other biological specimens or animal models, but not intact human subjects. Research in Biomedical Laboratory Research and Development emphasizes projects that will ultimately lead to improvements in clinical practice. Examples of relevant diabetes research include studies on prevalence and clinical significance of antibodies in patients with recently diagnosed type 2 diabetes, genetics, weight loss, and glucose metabolism in older men.

The Health Services Research and Development program strives to advance knowledge, develop VA health services, researchers, and leaders, and promote innovations that translate into advances in health care for veterans and the nation. Health Services Research covers all areas of health care delivery. The diabetes-related portfolio includes screening for diabetes in veterans, a study of telephone-based disease management for patients with diabetes, stroke prevention in veterans with diabetes, and enhanced description, identification, classification, and treatment of foot ulcers in patients with diabetes. Eleven Health Services Research and Development (HSR&D) Centers of Excellence focus on linking research to patient care. The development of information through research does not necessarily mean that that information is applied at the bedside. Therefore, the VA is expanding research designed to identify barriers to the rapid translation of research and to study new organizational structures with the potential to remove those barriers. The HSR&D Quality Enhancement Research Initiative (QUERI) is a comprehensive, data-driven, outcomes-based quality improvement program to translate research discoveries and innovations into better patient care and health care systems improvement through ongoing critical self-evaluation, learning, and measured change. The diabetes QUERI is described in a companion article in this supplement.

The Rehabilitation Research and Development Service (RR&D) addresses the prevention and minimization of disability and restoration of function in veterans with impairments. Each of 12 specialized centers of excellence is involved in research on a focused rehabilitation topic, training, and outreach to veterans. A variety of other funding mechanisms is available to support rehabilitation research. RR&D actively supports investigation to prevent, treat, or rehabilitate persons at risk of limb loss. Rehabilitation researchers were responsible for the development of the Seattle Foot, a prosthesis that facilitates mobility and functioning in amputees with and without diabetes.

Diabetes-related research was broadly defined and investigated from FY1998 to FY2003. On an annual basis, VA investigators provide a research abstract on their research projects. We searched this research abstract system for research that included diabetes, diabetes complications, and the word “diabetes” in the title or text of the abstract or as a discrete MeSH term (c 18.452.297 and C 19.246).

Table 2 provides a summary of diabetes-related research broadly defined by year, number of projects, source, and amount of funds. Research funding was awarded for pilot funding, pre- and postdoctoral training, merit review applications, career development, career scientists, and center grants. Table 2 also shows sizeable increases in both the number of VA diabetes-related research projects and the funding resources. Over this 16-year interval, non–VA-funded research projects grew >3-fold, while the supporting research dollars increased 10-fold. The strong education and training mission of the VA explains the large number of projects initiated without funding. These diabetes-related projects were conducted with existing personnel and local support or as part of an existing, funded VA research program. For example, many pre- and postdoctoral fellows and physicians in training received local assistance to conduct thesis, dissertation, and other research and thus did not need to apply for peer-reviewed research support.

The VA was the leading source of funding for diabetes-related projects. The merit review mechanism accounted for the majority of funds spent by the VA on diabetes-related research during this interval. Table 3 shows non–VA-funded research in 2003; the National Institutes of Health provided 69% of the resources, followed by nonfederal sources at 12% (state, university, and private corporations), nonprofit foundations at 11%, and other federal sources at 8%.

Examples of VA- and non–VA-funded diabetes clinical trials during this interval included trials of hypoglycemic and lipid-lowering medication and special footwear for persons with diabetes. The VA also participated in large national collaborative trials, including the National Institutes of Health’s Diabetes Prevention Program, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, and the National Center for Research Resources’ Precose Resolution of Optimal Titration to Enhance Current Therapies Study (2–4).

VA investigators continue to play major roles in both VA- and non–VA-funded clinical trials relevant to diabetes. Given the liberal definition we used for “diabetes-related,” these findings may appear to inflate the agency’s diabetes-related research. We were cognizant of the underlying mechanisms involved in diabetes pathogenesis, diagnosis, treatment, costs, and outcomes, and all were included in this search.

Other major qualitative changes that occurred during this interval were expanded collaborations between the Office of Research and Development and the Centers for Medicare and Medicaid Services, National Institutes of Health, Centers for Disease Control, the American Diabetes Association, Juvenile Diabetes Foundation, and international and private corporations. In addition, the Diabetes QUERI has become a strong research center, now stimulating and supporting an increased number of diabetes-related research projects that address gaps in VA diabetes care.

In conclusion, this article summarizes diabetes activities and funding supported by the VA Office of Research and Development and other agencies. The VA was the major source of funds to support these activities, with the National Institutes of Health providing the second largest amount. Many research projects are conducted largely in support of trainees. Diabetes-related research is conducted across all VA research services and covers the full spectrum of investigative designs, from bench research to clinical trials. The VA, with its national distribution of health care facilities; advanced clinical information systems, resources, and researchers; and large population of patients with diabetes, can anticipate an even larger future role in diabetes research.

This research was supported by the VA Seattle Epidemiologic Research and Information Center and the Cooperative Studies Program. We appreciate the advice and assistance from Jack Wu and others in the VA Research and Development Office and the VA Puget Sound Health Care System Research and Development Office.