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

Part of paid clinical trials in Bemidji, Minnesota.

Sponsor
Sanford Health
Study ID
NCT04477928
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Minutes - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Sera and whole blood sampling — DIAGNOSTIC_TEST
    * 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) — DIAGNOSTIC_TEST
    Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age

Study Details

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.

Key Dates

Start date
Jul 17, 2020
Status verified
Feb 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
33,000 participants (estimated)

Arms

  • Arm: Study Group
    Children receiving routine care at a Sanford facility

Primary Outcome Measure

Demonstrated feasibility of large-scale population screening, as evidenced by: [ Time Frame: By year 10 of the study ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Sanford Bemidji Region ClinicsBemidjiMinnesota56601
Ann Mays, RN, CPN
[email protected]
605-312-6052
Kurt Griffin, PhD, MD (PRINCIPAL_INVESTIGATOR)
Sanford Bismarck Region ClinicsBismarckNorth Dakota58501
Ann Mays, RN, CPN
[email protected]
605-312-6052
Kurt Griffin, PhD, MD (PRINCIPAL_INVESTIGATOR)
Sanford Fargo Region ClinicsFargoNorth Dakota58112
Ann Mays
[email protected]
605-312-6052
Kurt Griffin, PhD, MD (PRINCIPAL_INVESTIGATOR)
Sanford Sioux Falls Region ClinicsSioux FallsSouth Dakota57105
Ann Mays
[email protected]
6053126052
Kurt Griffin, PhD, MD (PRINCIPAL_INVESTIGATOR)
Sharon Hunt, BS, MS, MBA (SUB_INVESTIGATOR)
Candice Nelson, MD, FAAP (SUB_INVESTIGATOR)
Stephanie Hanson, MD, FAAP (SUB_INVESTIGATOR)
Louis Casas, MD, FAAP (SUB_INVESTIGATOR)
Brenda Thurlow, MD, FAAP (SUB_INVESTIGATOR)
Kyle Baum, MD (SUB_INVESTIGATOR)
Ann Mays, RN, CPN (SUB_INVESTIGATOR)

Find similar trials in Bemidji, MN

By condition
Celiac diseaseType 1 diabetes
By specialty
GastroenterologyAutoimmune diseaseEndocrinology
By research site
Sanford Bemidji Region Clinics· Bemidji, MNSanford Bismarck Region Clinics· Bismarck, NDSanford Fargo Region Clinics· Fargo, NDSanford Sioux Falls Region Clinics· Sioux Falls, SD

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