Trials / Recruiting
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 33,000 (estimated)
- Sponsor
- Sanford Health · Academic / Other
- Sex
- All
- Age
- 0 Minutes – 17 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes. The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-07-17
- Primary completion
- 2031-03-01
- Completion
- 2031-03-01
- First posted
- 2020-07-20
- Last updated
- 2026-03-02
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04477928. Inclusion in this directory is not an endorsement.