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RECRUITING
NCT04477928

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

Sponsor: Sanford Health

View on ClinicalTrials.gov

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

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

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