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Sanford PLEDGE Study: Type 1 Diabetes and Celiac Disease Risk Screening

This observational study, called the Sanford PLEDGE Study, is looking at how well we can screen children for their risk of developing Type 1 Diabetes (T1D) and Celiac Disease during their regular doctor visits. Researchers will collect blood samples at different ages (birth, 2, 5, or between 9-16 years old) to check for specific markers (autoantibodies) related to these conditions. Some participants may also have additional genetic testing. The main goal is to see if this large-scale screening is practical and can be done effectively. This study is currently recruiting children from birth up to 17 years old.

Study design
This is an observational study planning to enroll 33,000 participants. It is not a randomized or blinded study.
What's involved
Participants will have blood samples taken during routine healthcare visits at specific ages (birth, 1, 2, 5 years, or once between 9 and 16 years). Some may also have cord blood and peripheral blood samples taken for genetic testing.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of large-scale screening will be measured by year 10 of the study.

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NCT04477928

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

Recruiting
Not specifiedAges 0–17Observational
Sanford Health
~33,000 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Sera and whole blood samplingDifferential Gene Expression (DGE)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrated feasibility of large-scale population screening, as evidenced by:
Measured over By year 10 of the study

Conditions

Type 1 Diabetes
Celiac Disease

Explore related trials

Celiac DiseaseType 1 Diabetes MellitusT1D-relevant antibodies

Where it's being run

4 sites across 3 states
North Dakota2
Minnesota1
South Dakota1

Study leadership

  • Kurt Griffin, PhD, MD · PRINCIPAL_INVESTIGATOR · Sanford Research

Who to contact

Ann Mays, RN, CPN
[email protected]
605-312-6052
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

    1. The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires. 2. Of those who consented to be in the study, the percentage who went on to obtain the initial sample. 3. Of the total samples collected, percentage that were valid and results received. 4. The percentage of subjects who complete their \~60 month visit by their 6th birthday.