The Endocrine Clinical Research Center of the University of Maryland School of Medicine is applying to become a DDCT Center. The Endocrine Clinical Research Center is a combined centralized inpatient and outpatient clinical research facility. It is centrally located in the Baltimore-Washington Corridor, one of the three largest urban population areas not currently served by the DCCT. The Clinical Research Team is headed by Dr. A. A. Kowarski, Professor of Pediatrics and Director of the Division of Pediatric Endocrinology. The research team is very experienced in precise performance of clinical research protocols and has completed numerous NIH and other funded clinical research protocols leading to nearly 50 diabetes related publications and over 170 clinical research papers. This has been a stable research team working together with Dr. Kowarski nearly 10 years, initially at Johns Hopkins Hospital and currently at University of Maryland for the last 5 years. This team participated in a number of multicenter clinical trials and are experienced in successful collaborative clinical research efforts. Members of the clinical research team have extensive experience in diabetes care and clinical diabetes research. They are fully experienced in use of tight diabetes control regimens with a substantial proporation of patients currently maintained with near normal to normal HgbA1C levels. They have used and published tight control techniques including insulin pump therapy, and use of HgbA1C and multiple dose therapy. We have an immediate pool of over 750 IDDM patients to recruit DCCT study patients from and centralized facilities with easy access for patients at the Endocrine CRC. We have 6 diabetologists with a large network of patients and contacts from which to enroll other appropriate study patients from the estimated 20,000 IDDM patients in our referral area. The clinical research team has a strong willingness to work cooperatively in this collaborative study. They realize the importance of meticulous standardized performance of the DCCT Protocol to ensure proper completion of the study. They fully agree to adhere to randomized enrollment of their study patients in the standard of tight treatment groups. The CRC has adequate space and necessary equipment to devote to the DCCT. This includes a trial coordinator's office solely for DCCT, 4 outpatient consultation-examining rooms, 3-bed inpatient clinical research unit (with optional 4th bed), blood drawing stations, and close proximity to office and necessary staff.
