Universal Type 1 Diabetes Screening in Pediatrics

Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes (T1D)
• Intervention / Treatment: Behavioral: Set of implementation strategies

Detailed 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, limited availability of pediatric endocrinologists, parent understanding and acceptability, and other structural barriers such as insurance coverage. Emerging recommendations from leading professional organizations worldwide, including the International Society for Pediatric and Adolescent Diabetes and the American Diabetes Association, highlight the potential of population-based screening; however, 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, acceptably, and appropriately integrated into routine pediatric well-child visits. Guided by implementation science, the study evaluates a set of implementation strategies that includes clinician education, clinician ordering reminders, and facilitation.

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 electronic health record (EHR) outcomes and collects surveys/interviews.

The research team will offer a set of implementation strategies 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 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. Preliminary implementation strategy effectiveness will also be examined by tracking the proportion of eligible individuals for which clinicians order screening (penetration), proportion of eligible individuals who complete screening (reach), and proportion of eligible individuals with ICD-10 codes documented for early-stage T1D (unspecified stage, E10.A0; Stage 1, E10.A1; Stage 2, E10.A2; clinical documentation).
2. Understand perspectives of multiple constituent groups, including parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts on 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 universal T1D screening across U.S. pediatric care settings.

• Study Type: Observational
• Enrollment (Estimated): 9500

Contacts and Locations

• Study Contact: Name: Rinad S Beidas, PhD; Phone Number: 312-503-0546; Email: Rinad.beidas@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration of T1D Screening	Penetration will be calculated from EHR data as proportion of patients who had screening ordered among those who were eligible to be screened	15 months preceding study period and 15 months of study period
Reach of T1D Screening	Reach will be calculated from EHR data as the proportion of patients who completed screening among those eligible to be screened, a definition of reach which aligns with best practices in the literature. As a second, less conservative measure of reach, we will assess the proportion of patients who completed screening among those who had screening ordered for them.	15 months preceding study period and 15 months of study period
Clinical Documentation	Clinical documentation will be measured from EHR data as the proportion of eligible patients with ICD-10 codes documented for early-stage T1D captured through screening (unspecified stage, E10.A0; Stage 1, E10.A1; Stage 2, E10.A2)	15 months preceding study period and 15 months of study period

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Sanofi

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pediatrics; Type 1 Diabetes; Implementation Science; Population-based Screening; Universal Screening; Islet Autoantibodies
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STU00224090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified individual participant data for our primary outcomes (including data dictionaries) will be made available, in addition to the informed consent form.
• IPD Sharing Time Frame: IPD and supporting information will be available after August 15, 2026, following the official launch of the study across all participating clinics.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No