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Universal Type 1 Diabetes Screening in Pediatrics

NCT07612475 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 9500

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes (T1D)

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.

Sponsors & Collaborators

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-10-19
Completion
2027-10-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612475 on ClinicalTrials.gov