Type 1 Diabetes Screening

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes (T1D)
• Intervention / Treatment: Other: Not applicable - observational study

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, 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.

• Study Type: Observational
• Enrollment (Estimated): 3500

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
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of T1D Screening	Reach will be calculated using both electronic health record (EHR) visit data and parent-reported data. Per EHR data, reach will be calculated as the number of children who completed the islet-autoantibody screening, divided by the number of eligible children during the study period. A secondary, less conservative calculation will use the number of completed screens divided by those for whom screening was ordered. EHR data is seen as the "ground truth" and parent-reported data will be used to supplement this information. Per parent-reported data, reach will be calculated as the number of parents who answered "yes" to the survey question asking if their child has completed the screening after their recent visit, divided by the total number of completed parent surveys.	15-month implementation window
Penetration of T1D Screening	Penetration will be calculated using both EHR visit data and parent-reported data. Per EHR data, penetration will be calculated as the number of children for whom clinicians ordered islet-autoantibody screening, divided by the number of eligible children during the study period. EHR data is seen as the "ground truth" and parent-reported data will be used to supplement this information. Per parent-reported data, penetration will be calculated as the number of parents who answered "yes" to the survey question asking if a member of the care team has ordered islet-autoantibody screening for their child during their recent visit, divided by the total number of completed parent surveys.	15-month implementation window

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): November 15, 2028

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): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 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)?: YES
• 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