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General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
NCT04477928 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Sera and whole blood sampling
- DIAGNOSTIC_TEST Differential Gene Expression (DGE)
Study Locations (4)
North Dakota
- Sanford Bismarck Region Clinics — Bismarck
- Sanford Fargo Region Clinics — Fargo
Minnesota
- Sanford Bemidji Region Clinics — Bemidji
South Dakota
- Sanford Sioux Falls Region Clinics — Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33,000 participants |
| Start Date | 2020-07-17 |
| Est. Completion | 2031-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04477928
The ClinicalTrials.gov registry entry for NCT04477928 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanford Health, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions — of which Sera and whole blood sampling is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04477928 reports 4 study locations spanning 3 distinct geographic areas — top geographies include North Dakota, Minnesota, South Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04477928 about?
NCT04477928 is a clinical study titled "General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery". 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.
What is the current status of trial NCT04477928?
This trial is currently recruiting. The enrollment target is 33,000 participants. The study started on 2020-07-17. Estimated completion is 2031-03.
What conditions does trial NCT04477928 study?
This clinical trial studies the following conditions: Type 1 Diabetes, Celiac Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04477928?
The interventions under investigation include: Sera and whole blood sampling (DIAGNOSTIC_TEST), Differential Gene Expression (DGE) (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04477928?
This trial is sponsored by Sanford Health, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04477928 being conducted?
This trial has 4 study locations across Minnesota, North Dakota, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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