Clinical Research Studies

Site for The TrialNet Natural History Study of the Development of T1D is divided into Screening and Monitoring stages. Each stage will require separate informed consent for entry. Screening involves testing relatives of individuals with diabetes for the presence of islet autoantibodies. Individuals who have autoantibodies will be enrolled into the Monitoring stage (see Appendix Schedule of Assessments). The study will use a prospective cohort design. The algorithm below shows the flow of participants in the Screening and Monitoring stages. The Screening stage involves measurement of GAD65A, IA-2A, and mIAA, (with a positive result for any of these leading to measurement of ICA and ZnT8A) to determine whether the participant is eligible for the Monitoring stage. As additional diabetes-related autoantibodies are discovered and validated, they may also be included in Screening. Participants will be eligible for Monitoring if they have at least two positive autoantibodies on a Screening sample or at least one positive autoantibody on two separate Screening samples. Participants younger than 18 years old who are negative for all autoantibodies will be offered annual autoantibody rescreening until their 18th birthday. Participants 18 or older with a single positive autoantibody on the first Screening sample but no positive autoantibodies on a confirmatory test will be offered annual rescreening for two years.