Status:
RECRUITING
General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Lead Sponsor:
Sanford Health
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Pacific Northwest Research Institute
Conditions:
Type 1 Diabetes
Celiac Disease
Eligibility:
All Genders
Up to 17 years
Brief Summary
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 ...
Detailed Description
Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children a...
Eligibility Criteria
Inclusion
- 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
- Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
- Children known to have T1D
Key Trial Info
Start Date :
July 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
33000 Patients enrolled
Trial Details
Trial ID
NCT04477928
Start Date
July 17 2020
End Date
March 1 2031
Last Update
April 22 2024
Active Locations (4)
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1
Sanford Bemidji Region Clinics
Bemidji, Minnesota, United States, 56601
2
Sanford Bismarck Region Clinics
Bismarck, North Dakota, United States, 58501
3
Sanford Fargo Region Clinics
Fargo, North Dakota, United States, 58112
4
Sanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, United States, 57105