General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Recruiting
Observational Study
Type 1 Diabetes
Celiac Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 0 Minutes – 17
- Sex
- Any
- Study type
- Observational
- Participants needed
- 33,000 (estimated)
- Sponsor
- Sanford Health · Other
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About This Trial
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.
Trial Locations
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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 Ho…
Contacts