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Type 1 Diabetes Screening

NCT07612475 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2026-05-28

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 is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test and how often families complete it when integrated into existing workflows. Insights from parents, clinicians, and organizational leaders 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

OTHER

Not applicable - observational study

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. Participating clinics receive implementation supports (education, facilitation, workflow integration, and consultation) to enable routine screening adoption. These are clinic wide quality improvement activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion.

Sponsors & Collaborators

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-12-15
Completion
2028-11-15

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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