Universal Type 1 Diabetes Screening in Pediatrics

This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.

NCT Number	NCT07612475
Lead Sponsor	Northwestern University Collaborators: Sanofi
Conditions	Type 1 Diabetes (T1D)
Enrollment	9,500 participants
Start Date	2026-07-20
Primary Completion	2027-10-19 (estimated)
Study Completion	2027-10-19 (estimated)
Updated on ClinicalTrials.gov	2026-07-20