Type 1 Diabetes Mellitus Clinical Trial
Official title:
Natural History of Pre-Diabetic Autoimmunity
Type 1 diabetes (T1D) affects 1.4 million people in the U.S. and its incidence has doubled over the past 20 years. The Diabetes Autoimmunity in the Young Study (DAISY) will estimate overall burden of T1D and other autoimmune diseases in the general population by age 30. The study will evaluate environmental risk factors for development of islet autoimmunity and progression to T1D.
Children determined to be at an increased risk for development of type 1 diabetes, either due to known genetic markers or due to family history of T1D, are followed from birth and monitored for development of T1D-related autoimmunity, on an annual basis. At annual clinic visits, participants are tested for development of these autoantibodies and data is collected related to environmental exposures. In addition to blood collection for determination of autoantibodies, serum and plasma are frozen, and stored for future analyses. Other biological samples collected for further future analysis include: throat swabs, rectal swabs, saliva, and urine. If T1D-related autoantibodies are detected, the participant is asked to increase the frequency of clinic visits to 2-4 visits per year in order to more closely monitor for onset of disease. The endpoint of the study is diagnosis of T1D per the American Diabetes Association (ADA) criteria. ;
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