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Screening Children for Type 1 Diabetes and Celiac Disease Risk During Routine Visits

Tests blood samples from children during routine care for type 1 diabetes and celiac disease.

Key facts

Who runs it
Sanford Health
Where
Bemidji, Bismarck, Fargo, and Sioux Falls, United StatesSee the 4 sites
Trial code
Registry title
General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Status
Recruiting
People taking part
33,000 people, planned
Started
17 Jul 2020
Expected to end
Mar 2031
Type of study
Observational
Treatments tested
  • Sera and whole blood sampling
  • Differential Gene Expression (DGE)
Record updated
2 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies, children and teens who get routine care at a Sanford health facility. It screens them for type 1 diabetes and celiac disease risk.

Age
From birth up to 17 years. Entry routes: newborns, children under 6 years, children 9-16 years, and siblings aged 6 to 17 years.
Sex
All sexes can join.
Disease stage
Children without known type 1 diabetes. Siblings of children with type 1 diabetes-related antibodies can also join.

Main reasons for not taking part

  • Children already known to have type 1 diabetes
  • People who cannot follow the study plan, in the investigator's opinion
  • No active MyChart account with proxy access

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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)

Who cannot take part

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

Where in United States

  • Sanford Bemidji Region ClinicsBemidji, United StatesContact: Ann Mays, RN, CPNTaking people
  • Sanford Bismarck Region ClinicsBismarck, United StatesContact: Ann Mays, RN, CPNTaking people
  • Sanford Fargo Region ClinicsFargo, United StatesContact: Ann MaysTaking people
  • Sanford Sioux Falls Region ClinicsSioux Falls, United StatesContact: Ann MaysTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Study Group

    Children receiving routine care at a Sanford facility

    Treatment: Sera and whole blood sampling and Differential Gene Expression (DGE)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
Plain-language title
Screening Children for Type 1 Diabetes and Celiac Disease Risk During Routine VisitsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 March 2026