Type 1 Diabetes Screening

Northwestern University

Status: Not yet enrolling

Conditions: Type 1 Diabetes (T1D)

Treatments: Other: Not applicable - observational study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07612475

STU00224090

Details and patient eligibility

About

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:

1. Assess feasibility, acceptability, and appropriateness of integrating population-based islet-autoantibody screening for T1D into pediatric primary care. Implementation effectiveness will also be examined by tracking how often clinicians order screening (penetration) and how often families complete screening (reach).
2. Understand perspectives of multiple constituent groups, including parents, clinicians, clinic administrators, payers, and leaders from relevant national organizations, regarding barriers and facilitators to implementing population-based T1D screening as part of standard pediatric preventive care.

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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children

• All children presenting for the 2-4, 6-8, and 11-15 year well-child visit at participating clinics, or otherwise eligible for T1D screening, or otherwise receiving blood test recommendations from clinicians that happen outside of these recommended age buckets or routine visits, will be eligible to have their data extracted from the electronic health record (EHR)

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

• All pediatric physicians and non-physician primary care providers (MD, DO, APP) employed at participating clinics will be eligible to complete the post-visit interview.
• All clinic staff at participating clinics, including members of the care team (e.g., medical assistants, nurses) as well as clinic leaders, administrative staff, and other staff (e.g., front-desk triage), will be eligible to complete the post-visit interview.

Exclusion criteria

• Parents/caregivers and children who have opted-out of participating in research at their clinic.