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

  • End date
    Mar 22, 2031
  • participants needed
  • sponsor
    Sanford Health
Updated on 22 March 2022
celiac disease
Accepts healthy volunteers


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.


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).

Condition Type 1 Diabetes, Celiac Disease
Treatment Sera and whole blood sampling, Differential Gene Expression (DGE)
Clinical Study IdentifierNCT04477928
SponsorSanford Health
Last Modified on22 March 2022


Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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