Universal Type 1 Diabetes Screening in Pediatrics

Sponsor
Northwestern University
Study ID
NCT07612475
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Set of implementation strategies — BEHAVIORAL
    This is an observational implementation study. The research team does not assign or deliver any clinical interventions. T1D screening orders and blood draws occur as part of routine care at clinician discretion, and the study observes EHR outcomes and collects surveys/interviews. The research team will deliver a set of implementation strategies (clinician education, clinician ordering reminders, and facilitation) to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These strategies will not be randomly assigned.

Study Details

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.

Key Dates

First listed
May 28, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Oct 19, 2027
Completion
Oct 19, 2027

Study Design

Enrollment
9,500 participants (estimated)

Primary Outcome Measure

Feasibility (Clinician Perspective) [ Time Frame: Towards the end of the study (approximately months 12-15) ]

Central Contacts

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