Epidemiology of Diabetes and Interventions and Complications (EDIC)

The DCCT/EDIC study has now been in progress continuously since 1983. The Core study requests each clinical center to see participants annually for a visit. For each participant, a core protocol ls performed which Includes: the major data collection form which reviews the participants' health history by system and updates inter-current events, denotes critical diabetes-related health Information Including all treatments, hypoglycemia severity, awareness, and prior 3-month frequency, and records the results of the standardized annual physical examination focusing on diabetes complications; standardized assessment of general physical and cognitive function; yearly HbA1c and EKG; fasting lipid profiles every other year; and ophthalmologist exam and eye imaging once in the five year grant period. Any hospitalizations, emergency room visits, new medical diagnoses, and/or new drug treatments reported at the annual exam or in between visits are further documented on additional forms and are aggressively followed by requests for medical records from the treating hospitals and providers. Major clinical events and deaths that require adjudication are also followed by requests for medical records from the treating hospitals and doctors. Data is collected and submitted through the MIDAS data entry system for analysis by the EDIC Data Coordinating Center. Additional ancillary studies are funded separately and EDIC centers are invited to perform these studies, which are delineated by ancillarystudy specific statements of work.