General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorSanford Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
Children known to have T1D
Trial design
Treatments tested in this trial
- Sera and whole blood sampling
- Differential Gene Expression (DGE)
Treatment groups
33,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Sanford Health
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Pacific Northwest Research Institute
Collaborator
University of Exeter
Collaborator
Source ClinicalTrials.gov