Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Clinical Research Center (Collaborative U01)

Funding Opportunity RFA-DK-16-508 from the NIH Guide for Grants and Contracts. 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 type 1 diabetes complications by 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 Clinical 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 cardiovascular disease, mortality, severe microvascular disease (blindness, kidney failure, amputation), neurocognitive impairments, and physical fragility. The EDIC Clinical 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 Institutional Review Board. The EDIC Clinical Research Center will also facilitate the conduct of all approved EDIC ancillary studies. The Clinical Centers will collect data in accordance with established study procedures and will submit all data and samples to the Biostatistics Research Center and central laboratory and other core facilities as appropriate and as required by the protocol(s). RFA DK-16-509 will support continuation of the EDIC Biostatistics Research Center.