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

Recruiting now

Conditions studied: Type 1 Diabetes, Celiac Disease

In brief

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.

Key facts

Study ID

NCT04477928

Run by

Sanford Health

People needed

33000

Starts

2020-07-17

Expected to finish

2031-03-01

Last updated by the study team

2026-03-02

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

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

Where it is running

• Sanford Bemidji Region Clinics — Bemidji, Minnesota, United States (enrolling)
• Sanford Bismarck Region Clinics — Bismarck, North Dakota, United States (enrolling)
• Sanford Fargo Region Clinics — Fargo, North Dakota, United States (enrolling)
• Sanford Sioux Falls Region Clinics — Sioux Falls, South Dakota, United States (enrolling)

Full record on ClinicalTrials.gov

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