Type 1 Diabetes Screening

NCT07612475 | Not Yet Recruiting

• 1 other identifier: STU00224090
• Study Type: observational
• Target: 3,500
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Implementation Science; Pediatrics; Type 1 Diabetes; Universal Screening; Islet Autoantibodies; Population-based Screening

Outcome Measures

Primary Outcomes (5)

• Acceptability (Parent Perspective)

  Parent perspectives will be assessed quantitatively through post-visit surveys by answering Likert-scale questions on the perceived acceptability of: (1) discussing T1D screening with a member of the care team during well-child visit and (2) having the child undergo a blood draw for T1D screening.

  Throughout study period (up to 18 months)

• Acceptability (Clinician Perspective)

  Clinician perspectives will be assessed quantitatively through phone interviews by answering Likert-scale questions on the perceived acceptability of offering population-based T1D screening at recommended ages during routine well-child visits.

  Throughout study period (up to 18 months)

• Feasibility (Clinician Perspective)

  Clinician perspectives will be assessed quantitatively through phone interviews by answering Likert-scale questions on: (1) the perceived feasibility of offering population-based T1D screening during well-child visits within the current workflow and (2) the perceived manageability of the logistics required to implement T1D screening in the practice.

  Throughout study period (up to 18 months)

• Appropriateness (Parent Perspective)

  Parent perspectives will be assessed quantitatively through post-visit surveys by answering Likert-scale questions on the perceived relevance of T1D screening for the child.

  Throughout study period (up to 18 months)

• Appropriateness (Clinician Perspective)

  Clinician perspectives will be assessed quantitatively through phone interviews by answering Likert-scale questions on the perceived relevance of T1D screening for the patient population.

  Throughout study period (up to 18 months)

Secondary Outcomes (2)

• Reach of T1D Screening

  15-month implementation window

• Penetration of T1D Screening

  15-month implementation window

Interventions

Not applicable - observational study OTHER

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and their parents/caregivers presenting for routine well-child visits at participating pediatric practices during the study period, as well as pediatric clinicians and clinic staff at participating practices who helped implement universal screening.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Rinad S Beidas, PhD

CONTACT

312-503-0546; Rinad.beidas@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): November 15, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after August 15, 2026, following the official launch of the study across all participating clinics.
• Access Criteria: The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal and after appropriate Institutional Review Board documents and Data Transfer and Use Agreements are in place. Proposals should be submitted to rinad.beidas@northwestern.edu.