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General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery

NCT04477928 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 33000

Last updated 2026-03-02

No results posted yet for this study

Summary

In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system.

Conditions

Interventions

DIAGNOSTIC_TEST

Sera and whole blood sampling

* Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry. * 2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies * 5 years old: T1D and celiac autoantibodies * 9-16 year old: one-time T1D and celiac autoantibodies * Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies

DIAGNOSTIC_TEST

Differential Gene Expression (DGE)

Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Pacific Northwest Research Institute

    collaborator OTHER

  • University of Exeter

    collaborator OTHER

  • Sanford Health

    lead OTHER

Principal Investigators

  • Kurt Griffin, PhD, MD · Sanford Research

Eligibility

Min Age
0 Minutes
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2031-03-31
Completion
2031-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477928 on ClinicalTrials.gov