Recruiting

Observational Study

Sponsor:

Sanford Health

Code:

NCT04477928

Conditions

Type 1 Diabetes

Celiac Disease

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

Interventions

Sera and whole blood sampling

Differential Gene Expression (DGE)

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Celiac Disease

Study ID

NCT04477928

Start date

Jul 17, 2020

Status verified date

Feb, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

33000 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Group

Children receiving routine care at a Sanford facility

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ann Mays, RN, CPN

605-312-6052ann.mays@sanfordhealth.org

Locations

Sanford Bemidji Region Clinics

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Ann Mays, RN, CPN

605-312-6052ann.mays@sanfordhealth.org

Principal Investigator:

Kurt Griffin, PhD, MD

Sanford Bismarck Region Clinics

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Ann Mays, RN, CPN

605-312-6052ann.mays@sanfordhealth.org

Principal Investigator:

Kurt Griffin, PhD, MD

Sanford Fargo Region Clinics

Recruiting

Fargo, North Dakota, United States, 58112

Contacts

Ann Mays

605-312-6052ann.mays@sanfordhealth.org

Principal Investigator:

Kurt Griffin, PhD, MD

Sanford Sioux Falls Region Clinics

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Ann Mays

6053126052ann.mays@sanfordhealth.org

Principal Investigator:

Kurt Griffin, PhD, MD

More Information

Sponsor

Sanford Health

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Population screening
  • Type 1 Diabetes
  • Celiac Disease
  • Autoantibodies
  • Prevention
  • Diabetic Ketoacidosis (DKA)
  • Genetic Risk Score
  • Differential Gene Expression
  • Economic Modeling
  • Quality of Life
  • Feasibility
  • Pragmatic
  • T1D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanford Health on 2026-03-02.