Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to continue to follow the Epidemiology of Diabetes Interventions and Complications (EDIC) cohort through a collaborative cooperative agreement. EDIC is an observational study that was launched at the completion of the Diabetes Control and Complications Trial (DCCT) trial. The DCCT showed that intensive therapy significantly reduced the risk of diabetes complications compared to conventional therapy. At DCCT completion, all cohort members were taught intensive diabetes therapy. In 1994, EDIC was launched to: (1) evaluate the long-term effects of DCCT intensive therapy, (2) describe the long-term effects of glycemia and other risk factors on diabetes complications, and (3) characterize type1 diabetes complicationsby supporting collaborative research to utilize the EDIC cohort as well as its data set and biologic/genetic samples. To date, EDIC has: (1) demonstrated a continued benefit of intensive therapy on the development and progression of diabetes complications, and (2) characterized the development and progression of diabetes complications. The primary purpose of this FOA is to support the EDIC Research Center to continue follow-up of the EDIC cohort to study the development of complications and the longer term course of type 1 diabetes in a well characterized type 1 diabetes population, including but not limited to severe microvascular disease (blindness, kidney failure, amputation),cardiovascular disease, liver disease, sleep disorders and mortality. The EDIC Research Center will manage and support EDIC Clinical Centers, which are responsible for the conduct of all EDIC core activities as described in the protocol and Manual of Operations and as required by the local and central Institutional Review Boards.