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

RecruitingObservational studyHealthy volunteers welcome

Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children

Who can join

0 Minutes – 17 Years · All sexes · Healthy volunteers welcome

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Sanford Health · Participants: 33,000 · Started: Jul 17, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04477928

Locations in the U.S.

MinnesotaSanford Bemidji Region Clinics, Bemidji
North DakotaSanford Bismarck Region Clinics, Bismarck
Sanford Fargo Region Clinics, Fargo
South DakotaSanford Sioux Falls Region Clinics, Sioux Falls

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.