Universal Type 1 Diabetes Screening in Pediatrics

NCT07612475 | Not Yet Recruiting

• 1 other identifier: STU00224090
• Study Type: observational
• Target: 9,500
• 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, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts 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)

• Feasibility (Clinician Perspective)

  Feasibility of screening and implementation strategies will be assessed using items adapted from the Feasibility of Intervention Measure (FIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)

  Towards the end of the study (approximately months 12-15)

• Acceptability (Parent Perspective)

  Parent perspectives on the acceptability (for both clinician recommendation of screening and undergoing a blood draw for screening; parents who received or completed each element will be asked about actual acceptability and those who didn't will be asked about anticipated acceptability). Survey questions will be adapted from the psychometrically validated Acceptability of Intervention Measure (AIM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).

  Throughout study period (15 months)

• Acceptability (Clinician Perspective)

  Acceptability of screening and implementation strategies will be assessed using items adapted from the Acceptability of Intervention Measure (AIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)

  Towards the end of the study (approximately months 12-15)

• Appropriateness (Parent Perspective)

  Parent perspectives on the appropriateness (i.e., relevance of screening; parents who completed screening will be asked about actual appropriateness and those who didn't will be asked about anticipated appropriateness). Survey questions will be adapted from the psychometrically validated Intervention Appropriateness Measure (IAM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).

  Throughout study period (15 months)

• Appropriateness (Clinician Perspective)

  Appropriateness of screening and implementation strategies will be assessed using items adapted from the Intervention Appropriateness Measure (IAM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)

  Towards the end of the study (approximately months 12-15)

Secondary Outcomes (3)

• Penetration of T1D Screening

  15 months preceding study period and 15 months of study period

• Reach of T1D Screening

  15 months preceding study period and 15 months of study period

• Clinical Documentation

  15 months preceding study period and 15 months of study period

Interventions

Set of implementation strategies BEHAVIORAL

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 set of implementation strategies (clinician education, clinician ordering reminders, and facilitation) to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These strategies will not be randomly assigned.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Children and their parents presenting for eligible well-child visits at participating pediatric practices, as well as pediatric clinicians and other care team members at participating practices.

You may qualify if:

• Children
• \- Clinics will be encouraged to select screening ages or visits that align with international consensus statements for screening during early childhood, mid-childhood, and preadolescence and routine U.S. well-child visit schedules, and that minimize workflow disruption and maximize screening completion, such as visits that already include blood draws for other routine tests (e.g., lead screening at age 2). Children who have visits at their clinic's selected ages will be eligible to have their data extracted from the electronic health record (EHR)
• Parents/Caregivers - All parents or legal guardians (hereafter, parents) who attended the well-child visit, who are eligible to have their child's EHR data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.
• Clinicians and Other Care Team Members
• All pediatric primary care clinicians (i.e., physician \[MD, DO\], nurse practitioner, physician assistant) at participating clinics will be eligible to complete an interview.
• All other care team members, including nurses, medical assistants, phlebotomists, and front desk staff at participating clinics will be eligible to complete an interview.

You may not qualify if:

• \- Parents who have opted-out of survey recruitment at their clinic will not be eligible for the survey/interview.

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: July 20, 2026
• Primary Completion (Estimated): October 19, 2027
• Study Completion (Estimated): October 19, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07