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General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Sponsor: Sanford Health
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.
Official title: Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
Key Details
Gender
All
Age Range
0 Minutes - 17 Years
Study Type
OBSERVATIONAL
Enrollment
33000
Start Date
2020-07-17
Completion Date
2031-03
Last Updated
2026-03-02
Healthy Volunteers
Yes
Conditions
Interventions
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
Differential Gene Expression (DGE)
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
Locations (4)
Sanford Bemidji Region Clinics
Bemidji, Minnesota, United States
Sanford Bismarck Region Clinics
Bismarck, North Dakota, United States
Sanford Fargo Region Clinics
Fargo, North Dakota, United States
Sanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, United States