A -- Epidemiology Diabetes Interventions and Complications - Clinical Coordinating Center

The National Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK) is planning a ten-year continuation of the follow-up study of approximately 1,400 subjects enrolled in the Epidemiology Diabetes Interventions and Complications (EDIC). Twenty-eight clinical centers have been participating under a contract awarded to Case Western Reserve University (CWRU) by NIDDK in this follow-up study of participants originally studied in a randomized, multi-centered clinical trial called the Diabetes Control and Complications Trial (DCCT). The DCCT began in 1982 with twenty-one centers and eight additional sites were added after the first three-year feasibility phase was completed. The twenty-nine clinical centers were funded by cooperative agreements awarded by NIDDK. The DCCT studied the effect of intensive blood glucose control on the occurrence of early microvascular complications of type 1 diabetes mellitus. The DCCT completed the intervention study in June 1993, and the main results were reported in the New England Journal of Medicine in September 1993. At the end of the DCCT, two study sites were combined so that twenty-eight centers continued to follow the DCCT patients. EDIC, the follow-on study to the DCCT, began in 1993 and was initially funded as a continuation of the DCCT cooperative agreements. Since 1996 CWRU has performed under contract with NIDDK as the EDIC Clinical Coordinating Center, with one clinical center located on-site at CWRU and the other twenty-seven clinical centers performing under subcontracts with CWRU. CWRU was chosen under a limited competition with the twenty-eight medical institutions that were the only known sources with access to the subjects who participated in the DCCT. The institutions are CWRU, University of Pennsylvania, Cornell University Medical Center, Henry Ford Hospital, Institute for Research and Education, Massachusetts General Hospital, Mayo Foundation, Medical University of South Carolina, Park Nicollet Medical Foundation, University of Iowa, University of Minnesota, University of Missouri - Columbia, University of Pittsburgh, University of Tennessee, University of Texas Southwestern Medical School , University of Toronto, University of Washington, University of Western Ontario, Vanderbilt University, Washington University at St. Louis, Yale University, Albert Einstein College of Medicine, Northwestern University, University of California, San Diego. University of Maryland at Baltimore, University of New Mexico Health Sciences Center, University of South Florida, and University of Michigan. Under the EDIC, long-term follow-up of this cohort has provided additional important scientific information on late macrovascular complications that were not studied in the DCCT. The EDIC study group has made the unexpected finding that - metabolic memory exists for the effect of blood glucose control on the development of complications in patients with type 1 diabetes. Despite similar levels of blood glucose control during the EDIC study, patients who were in the DCCT intensively treated group have had much slower progression of retinopathy, nephropathy, and cardiovascular event markers than the DCCT standard group patients. This has been documented in multiple peer-reviewed publications (see attachment). It is the intention of the Government to negotiate with CWRU a ten-year follow-on contract to perform as the EDIC Clinical Coordinating Center (EDIC CCC). CWRU has served as the EDIC CCC and has established and managed subcontracts with the other EDIC 27 centers since 1996. In this role CWRU has developed the experience and expertise to efficiently manage these contracts. The participants are a closed population so the subcontracts for the extension of EDIC will be with the same 27 institutions which are the only sources with access to the approximately 1,400 EDIC subjects. None of the other twenty-seven EDIC clinical centers with access to the EDIC participants have the staff, organization, experience, and facilities to perform as the EDIC CCC. The EDIC CCC is responsible for supervising and monitoring the subcontractors performance for the approximately 1,400 patients at the twenty-eight clinical centers. The EDIC CCC is responsible for supervising the structure and functioning of the EDIC clinics. This includes monitoring the performance of study personnel, approving the allocation of study FTE, approving changes in clinical center Principal Investigators, providing uniform supplies to the clinics for performance of the subjects assessments, supporting the preparation and submission of informed consent documents, and monitoring the performance of subject assessments and data collection. The subject assessments include obtaining blood specimens for biochemical analysis of renal and metabolic status in central labs, renal function evaluation, ultrasound and electrocardiograph macrovascular assessment, stereo fundus photographs of the retina, carotid ultrasound examinations, and coronary calcification computed tomography scans. The EDIC CCC has developed an interactive relationship with the 27 subcontracting centers. Subcontracts are issued for the study deliverables and continuously monitored. The EDIC CCC compiles, completes, and submits all financial reports for the 28 institutions (including itself). Authority: 41 USC 253 (c)(1). See Note 22.