Type 1 Diabetes Pathway to Prevention Study (Natural History) Study

Brief description of study

TrialNet is a research group dedicated to the study, prevention, and early treatment of type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the diagnosis of type 1 diabetes. This study will help us learn more about how type 1 diabetes occurs and provides monitoring to individuals at risk. In addition, the study will help us identify people who may be eligible for prevention trials. The study is divided into two parts: Screening and Monitoring. During screening, subjects will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body’s immune system. If autoantibodies are present, it could mean that cells in the pancreas which produce insulin are damaged. Certain kinds of autoantibodies can be found in the blood years before type 1 diabetes occurs. The Monitoring part offers follow-up visits for people found to have autoantibodies at screening.

Clinical Study Identifier: s19-00091
ClinicalTrials.gov Identifier: NCT00097292
Principal Investigator: Mary Patricia Gallagher.

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