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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.
Full description
Background:
Type 1 diabetes (T1D) is the most common form of diabetes in children and adolescents, affecting approximately 1 in 300 young people in the United States. The disease results from autoimmune destruction of pancreatic β-cells and often progresses silently over months to years before clinical symptoms emerge. Although first-degree relatives have a substantially higher risk of developing T1D, most children diagnosed with T1D do not have a family history of the disease. The presence of multiple islet autoantibodies is associated with an almost certain lifetime risk of insulin-requiring diabetes, and early identification before symptom onset can significantly reduce rates of life-threatening diabetic ketoacidosis (DKA), support structured monitoring, and potentially allow for disease-modifying interventions.
Despite clear benefits, early detection through autoantibody screening is not routinely implemented in U.S. pediatric primary care. Currently, screening largely occurs in research settings, and little is known about how best to integrate universal T1D screening into busy community pediatric practices. Key concerns include workflow burden, clinician capacity, lack of skilled pediatric endocrinologists, parent understanding and acceptability, and other structural barriers such as insurance coverage. Emerging recommendations from the American Diabetes Association highlight the potential for population-based screening, but practical strategies for real-world implementation remain underdeveloped.
This study is designed to generate practice-informed evidence on how universal T1D islet-autoantibody screening can be feasibly and acceptably integrated into routine pediatric well-child visits. Guided by implementation science and behavioral science principles, the study evaluates an implementation approach that includes education, workflow integration, and facilitation for clinicians and clinic staff.
Observational Study Model:
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 package of implementation supports to all participating clinics. These supports will not be randomly assigned.
Study Objectives:
Findings from this study will inform future scale-up efforts and support the development of implementation strategies for integrating early T1D detection across U.S. pediatric care settings.
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Inclusion criteria
Children
Parents/Caregivers
- All parents/caregivers who attended the well-child visit, who are eligible to have their child's data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.
Clinicians and Clinical Staff
Exclusion criteria
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Central trial contact
Rinad S Beidas, PhD
Data sourced from clinicaltrials.gov
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