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Universal Type 1 Diabetes Screening in Pediatrics

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Enrolling by invitation only Show 6 more changesShow less
    • Trial sites expanded: 0 → 8 locations
    • Primary and study completion dates: Oct 19, 2027 to Oct 16, 2027
    • Start date changed from estimate of Jul 20, 2026 to Jul 17, 2026
    • Secondary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words
  2. Enrollment increased: 3500 → 9500 participantsv2 Show 8 more changesShow less
    • Primary completion moved earlier from Dec 15, 2027 to Oct 19, 2027
    • Study completion moved earlier from Nov 15, 2028 to Oct 19, 2027
    • Start date: Jul 15, 2026 to Jul 20, 2026
    • Interventions: Not applicable - observational study (Other) to Set of implementation strategies (Behavioral)
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 68 words
    • Study title expanded, about 3 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07612475
Lead Sponsor Northwestern University
Collaborators: Sanofi
Conditions
(from sponsor)		 Type 1 Diabetes (T1D)
Related terms Diabetes Mellitus, Type 1
Enrollment 9,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov