This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. TrialNet is a network of 18 Clinical Centers working in cooperation with screening sites throughout the US, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. The network is dedicated to the study, prevention, and early treatment of Type 1 Diabetes (T1D). Trial Net is supported by the NIH, National Institute of Diabetes amp; Digestive amp; Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Center for Research Resources, US Department of Health amp; Human Services, JDRF, and ADA. TrialNet will develop clinical trials that fall into 2 broad categories: those for individuals with newly diagnosed T1D and those for individuals at risk for T1D. The TrialNet Natural History Study of the Development of T1D is a multi-centered study, using a prospective cohort design. The goals of the study are to both gain information about the pathogenesis and natural history of T1D and to facilitate the recruitment and assessment of individuals who might qualify for T1D prevention trials. Participants will be non-diabetic, 1-45 years of age, and have a sibling, child, or parent with T1D or be non-diabetic, 1-20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or grandparent with T1D. The study is divided into three phases: Screening (Phase 1), Baseline Risk Assessment (Phase 2) and Follow-up Risk Assessments (Phase 3). Each phase requires separate informed consent for entry. Phase 1 involves screening via a basic blood draw for the presence of autoantibodies associated with T1D. Participants who test positive for autoantibodies will be eligible for entry into Phase 2 of the study, the Baseline Risk Assessment. Phase 1 participants under 18 years of age who do not test positive for autoantibodies will be invited back yearly for phase 1 screening. Phase 2, Baseline Risk Assessment, is a 1-time visit (for most patients) requiring more in-depth laboratory measurements for determining a participant s risk of developing diabetes. During Phase 3, Follow-up Risk Assessments, participants will be seen at six-month intervals for five years or until the end of the study. Participants who qualify for prevention trials based on their risk assessments will be invited to participate in those trials as they become available.
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