Director of Coordinating Center: Patricia Cleary, M.S.

pidemiology of Diabetes Interventions and Complications (EDIC) is a multi-center, longitudinal, observational study designed to utilize the well- characterized DCCT cohort of 1419 patients (EDIC, 1999). Data collection focuses on nephropathy and macrovascular complications. Periodic measurements (using DCCT methods, standardized protocols and central laboratories) of vascular events, albumin excretion, GFR, ECG, ankle-brachial BP index, carotid wall thickness, serum lipids and HbA1c allows the following analyses: 1) continuation of intention-to- treat analyses to determine long-term effects of prior separation of glycemic levels; 2) risk factors for macrovascular outcomes; 3) correlation of progression of micro- and macrovascular outcomes. The current updated version of the EDIC protocol is available for download.

DIC began in 1994 and to date has studied more than 90% of the cohort at each annual visit. Numerous manuscripts and presentations have been published, all based on the EDIC data.

DIC is collaborating with two other studies: “ Markers and Mechanisms of Macrovascular Disease in Type 1 Diabetes” (Medical University of South Carolina) and “Multifactoral Origins of Dislipidemia in Type 1 Diabetes” (University of Washington).

he Biostatistics Center serves as the Data Coordinating Center (DCC) for this epidemiological study. The DCC coordinates the biostatistical and methodological activities of the 28 clinical centers and five laboratories/reading centers. EDIC is designed to continue data collection through 2003. John M. Lachin, Sc.D., the Principal Investigator and Patricia Cleary, M.S., the Co-principal Investigator and Director of the Data Coordinating Center.

oes Treatment Affect Cognition in Type 1 Diabetes is an ancillary EDIC study. The goal of this study is to reassess the DCCT/EDIC cohort using the original DCCT neurobehavioral test battery- two decades after the initial testing, augmented by measures that will allow for characterization on several aspects of cognitive function previously found to be affected by the metabolic abnormalities of diabetes. It is anticipated that 90% of the currently active 1404 EDIC subjects will participate in this study. This study is being conducted at 28 EDIC clinic sites across the U.S. and Canada. Joslin Diabetes Center functions as the main Coordinating Center, with the University of Pittsburgh serving as the Central Reading Unit for the test battery. Test scores will be stored in a central database maintained at The George Washington University Biostatistics Center- the Data Coordinating Center (DCC). The DCC will also coordinate the biostatistical and methodological activities related to this study.