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NCT07612475

Universal Type 1 Diabetes Screening in Pediatrics

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

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.

Official title: Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

OBSERVATIONAL

Enrollment

9500

Start Date

2026-07-20

Completion Date

2027-10-19

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Set of implementation strategies

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.