RecruitingNCT04477928

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

Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children

Sponsor

Sanford Health

Enrollment

33,000 participants

Start Date

Jul 17, 2020

Study Type

OBSERVATIONAL

Conditions

Celiac Disease Type 1 Diabetes

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.

Eligibility

Min Age: 0 MinutesMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study aims to identify children at risk for Type 1 diabetes by testing blood sugar-related markers during routine doctor visits — without requiring any extra appointments. The goal is to catch Type 1 diabetes early, before serious complications develop. **You may be eligible if...** - You are a newborn (at least 36 weeks gestation) born at a Sanford Health hospital - You are a child under 6 years old who receives routine care at a Sanford clinic - You are a child aged 9–16 receiving routine care at a Sanford facility - You are a sibling (ages 6–17) of a child known to have Type 1 diabetes-related antibodies - You receive regular care at a Sanford facility **You may NOT be eligible if...** - You do not receive care at a Sanford Health facility - A parent or guardian is unable to provide consent Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSera 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_TESTDifferential Gene Expression (DGE)

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