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

Last updated: April 19, 2024
Sponsor: Sanford Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Celiac Disease

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Treatment

Sera and whole blood sampling

Differential Gene Expression (DGE)

Clinical Study ID

NCT04477928
PLEDGE
  • Ages < 17
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 33000
Treatment Group(s): 2
Primary Treatment: Sera and whole blood sampling
Phase:
Study Start date:
July 17, 2020
Estimated Completion Date:
March 31, 2031

Study Description

Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes.

The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).

Connect with a study center

  • Sanford Bemidji Region Clinics

    Bemidji, Minnesota 56601
    United States

    Active - Recruiting

  • Sanford Bismarck Region Clinics

    Bismarck, North Dakota 58501
    United States

    Active - Recruiting

  • Sanford Fargo Region Clinics

    Fargo, North Dakota 58112
    United States

    Active - Recruiting

  • Sanford Sioux Falls Region Clinics

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

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