Screening children for Type 1 Diabetes and Celiac Disease risk during routine healthcare visits
Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
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 |
|---|---|
| Enrollment | 33000 (estimated) |
| Ages | 0 Minutes to 17 Years |
| Sex | All |
| Sponsor | Sanford Health Academic / other |
| Locations | 4 sites (Bemidji, Minnesota and 3 other locations) |
| Trial ID | NCT04477928 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include newborns, young children, and adolescents receiving routine care at Sanford facilities, particularly those with a family history of T1D.
Not a fit: Patients who are already diagnosed with Type 1 Diabetes will not benefit from this study.
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 performed: Other studies have shown promise in early screening for autoimmune conditions, suggesting that this approach may be beneficial.
Eligibility criteria
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 this trial is running
Bemidji, Minnesota and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.