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NCT07612475

Type 1 Diabetes Screening

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 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.

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

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

OBSERVATIONAL

Enrollment

3500

Start Date

2026-07-15

Completion Date

2028-11-15

Last Updated

2026-05-28

Healthy Volunteers

No

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.