NCT04477928Recruiting
General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 33000 (estimated)
- First submitted
- 13 Jul 2020
- Start date
- 17 Jul 2020
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- Sanford Health
- Diseases
- Type 1 diabetes
- NCT number
- NCT04477928
What you commit to
- Study type: Observational
- Planned participants: 33000
- From 17 Jul 2020 to the primary completion date, 31 Mar 2031
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
- Children known to have T1D
Who the study is looking for
- 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).
Age in the registry: 0 Minutes to 17 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanford Bemidji Region Clinics Coordinator of this site? Confirm its status | Bemidji | United States | Recruiting |
| Sanford Bismarck Region Clinics Coordinator of this site? Confirm its status | Bismarck | United States | Recruiting |
| Sanford Fargo Region Clinics Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Sanford Sioux Falls Region Clinics Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.