Sanford Population Level Estimation of Type 1 Diabetes Risk Genes in Children

What this Trial Is About

Researchers are studying the feasibility of screening the general population of children for type 1 diabetes T1D and celiac disease autoantibodies during routine healthcare visits. The study aims to identify children at risk for T1D early to prevent serious illness at diagnosis and improve long-term health outcomes. This observational study is conducted within an integrated health system in partnership with the Helmsley Charitable Trust. Children are screened for blood markers related to T1D and celiac disease at specific ages newborns at birth, then at 1, 2, and 5 years old, or once between 9 and 16 years old. Siblings of children with T1D autoantibodies, aged 6 to 17 years, also undergo one-time screening. The study includes serum and whole blood sampling for genetic risk scores and autoantibodies, with optional gene expression testing from cord blood and peripheral blood. Participants will receive routine care at Sanford facilities, and the study involves blood tests collected at scheduled ages. Researchers will monitor the occurrence of autoantibodies, track seroconversion rates, and record referrals to clinical care for celiac disease. The primary outcome is demonstrating the feasibility of large-scale population screening by year 10. Participants may be offered enrollment in additional monitoring or prevention studies if autoantibodies are detected, and safety and cost assessments will be conducted during the study period, which continues until 2031.

General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery