zes our experience as an Affiliate site for an NIH Grant held by the University of Southern California. This study began in 1994 in the Medical Tower with David S. H. Bell, M.D. as the Primary Investigator and Joy Atchison, M.D. as Co-Investigator. The study originally began with Screening for Islet Cell Antibodies (ICA) and Staging to determine if siblings or immediate family of newly diagnosed Type 1 diabetics were at risk of developing the disease. Subjects with a positive ICA test were then asked to participate in the Staging Process to determine if they were at low, moderate or high risk for developing diabetes as indicated by the amount of Islet Cell Antibodies present. The study was subsequently renewed on April 12, 1995. In January of 1996, Dr. Joy Atchison, M.D., became the Principal Investigator and the study was moved from the Medical Towers facility to Children's Hospital. In February 1996 an Intervention phase was added to the Study. The Intervention Phase was approved by the IRB on February 14, 1996. The Intervention Phase was parenteral insulin and oral insulin testing as a preventive measure against the development of Type 1 Diabetes. Those with a 25-50% risk or moderate risk would be randomized to parenteral insulin or no insulin group. In March of 1999 Fernando Ovalle, M.D. took over as the Principal Investigator of the study when Dr. Atchison left Children's Hospital to go into private practice. The study remained at Children's Hospital until October of 1999 when the coordination changed to the Division of Endocrinology and Metabolism, Clinical Trials Unit, notification of the change was sent to the IRB. Subjects continue to be screened at Children's Hospital but, are now staged at the General Clinical Research Center (GCRC), housed in the West Pavilion. Administration and Coordination for the study, Case Report Forms, Charts and Regulatory Documents are now housed in the Division of Endocrinology and Metabolism, Clinical Trials Unit on the 8th floor of the Diabetes Research and Education Building in room 817.
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