Screening children for Type 1 Diabetes and Celiac Disease risk during routine healthcare visits
Official title: Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
Run by Sanford Health · NCT04477928 · Data updated 2026-11-12
This study is testing whether screening young children for signs of Type 1 Diabetes and celiac disease during regular doctor visits can help catch these conditions early and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Minutes to 17 Years |
| Sex | All |
| Enrollment | 33000 (estimated) |
| Sponsor | Sanford Health Academic / other |
| Locations | 4 sites (Bemidji, Minnesota and 3 other locations) |
| Status | Recruiting |
| Started | July 17, 2020 |
| Main results expected | March 2031 |
| Study ends | March 2031 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT04477928 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include newborns, young children, and adolescents receiving routine care at Sanford facilities, particularly those with a family history of T1D.
✕Probably not a fit
Patients who are already diagnosed with Type 1 Diabetes will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the feasibility of screening children for Type 1 Diabetes (T1D) and celiac disease autoantibodies during routine healthcare visits. Children aged 0-5.99 and 9-16 years will be screened for blood markers related to these conditions at specific intervals. The goal is to identify children at risk for T1D early, potentially preventing serious illness and improving long-term health outcomes. Those identified with autoantibodies will be offered participation in further monitoring or prevention trials.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification and intervention for children at risk of Type 1 Diabetes and celiac disease, improving their health outcomes.
How similar studies have gone: Other studies have shown promise in early screening for autoimmune conditions, suggesting that this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Sanford Bemidji Region Clinics
Bemidji, Minnesota, United States Recruiting -
Sanford Bismarck Region Clinics
Bismarck, North Dakota, United States Recruiting -
Sanford Fargo Region Clinics
Fargo, North Dakota, United States Recruiting -
Sanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, United States Recruiting
Study contacts
- Principal investigator: Kurt Griffin, PhD, MD — Sanford Research
- Study coordinator: Ann Mays, RN, CPN
- Email: ann.mays@sanfordhealth.org
- Phone: 605-312-6052
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mediterranean diet and processed food in adults with celiac disease on a gluten-free diet
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-
Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity
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Exercise for Metabolic Syndrome and Fatty Liver in Adolescent Girls with Celiac Disease
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CGM-guided carb awareness education for adults with Type 1 diabetes
This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.