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General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery

Study acronym: PLEDGE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Site contacts updated at 1 of 4 sitesv6
  2. Re-verified, no change to tracked fieldsv5
  3. Study Status, Arms and Interventions, Eligibility, Referencesv4
  4. Enrollment target: 3000 to 33000v3 Show 9 more changesShow less
    • Primary completion date: Dec 2028 to Mar 2031
    • Primary endpoints: 2 to 1
    • Study sites: 1 to 4
    • Study completion date: Dec 2030 to Mar 2031
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: 10 to 8
    • Study description expanded, about 74 words
    • Study arms: 2 to 1
    • Study title shortened, about 3 words
  5. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 4 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanford Health
17 trials monitored
See all monitored trials
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 1 Diabetes
886 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT04477928
Lead Sponsor Sanford Health
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Pacific Northwest Research Institute, University of Exeter
Conditions
(from sponsor)		 Type 1 Diabetes, Celiac Disease
Related terms Celiac Disease, Diabetes Mellitus, Type 1, Diabetic Ketoacidosis, Genetic Risk Score
Enrollment 33,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov