NCT07612475Enrolling by invitation
Universal Type 1 Diabetes Screening in Pediatrics
Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 9500 (estimated)
- First submitted
- 20 May 2026
- Start date
- Jul 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Northwestern University
- Diseases
- Type 1 diabetes
- NCT number
- NCT07612475
What you commit to
- Study type: Observational
- Planned participants: 9500
- From Jul 2026 to the primary completion date, Oct 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Parents who have opted-out of survey recruitment at their clinic will not be eligible for the survey/interview.
Who the study is looking for
- 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.
Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pediatric Associates of Alexander City Coordinator of this site? Confirm its status | Alexander City | United States | Unknown status |
| RBK Pediatrics - Bay Shore Coordinator of this site? Confirm its status | Bay Shore | United States | Unknown status |
| Bloom Pediatrics - Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Bloom Pediatrics - Bloomfield Coordinator of this site? Confirm its status | Bloomfield Township | United States | Unknown status |
| RBK Pediatrics - Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Bloom Pediatrics - Detroit Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Pediatrics of Greater Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Bloom Pediatrics - Southfield Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.