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Clinical Trial 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 is incorporated into routine health care visits within an integrated health system.


Clinical Trial 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 at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes. The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04477928
Study type Observational
Source Sanford Health
Contact Ann Mays, RN, CPN
Phone 605-312-6052
Email ann.mays@sanfordhealth.org
Status Recruiting
Phase
Start date July 17, 2020
Completion date March 2031

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