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

Sanford Health · with The Leona M. and Harry B. Helmsley Charitable Trust, Pacific Northwest Research Institute · NCT04477928

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Up to age 17 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
33000
US sites recruiting
4
Study start
July 17, 2020
Record last updated
March 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Sera and whole blood sampling; Differential Gene Expression (DGE)

Conditions: Type 1 Diabetes; Celiac Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic
  • Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.
  • Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.
  • Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic
  • Have an active MyChart account (with proxy access).

Exclusion Criteria

  • Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
  • Children known to have T1D

Recruiting US locations

  • Sanford Bemidji Region Clinics

    Bemidji, MN 56601

    Site contact: Ann Mays, RN, CPN · 605-312-6052 · ann.mays@sanfordhealth.org

  • Sanford Bismarck Region Clinics

    Bismarck, ND 58501

    Site contact: Ann Mays, RN, CPN · 605-312-6052 · ann.mays@sanfordhealth.org

  • Sanford Fargo Region Clinics

    Fargo, ND 58112

    Site contact: Ann Mays · 605-312-6052 · ann.mays@sanfordhealth.org

  • Sanford Sioux Falls Region Clinics

    Sioux Falls, SD 57105

    Site contact: Ann Mays · 6053126052 · ann.mays@sanfordhealth.org

Study contacts (from the official record)

  • Ann Mays, RN, CPN · 605-312-6052 · ann.mays@sanfordhealth.org
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General Population Level Estimation for Type 1 Diabetes Risk in… (NCT04477928) | Bored Studies