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NCT04477928 · ClinicalTrials.gov registry record
General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
A clinical trial of Type 1 Diabetes and Celiac Disease, sponsored by Sanford Health.
- Recruiting
- Registry status
- 33,000
- Enrollment target
- 4
- Study locations
NCT04477928: Recruiting study of Type 1 Diabetes and Celiac Disease, sponsored by Sanford Health.
NCT04477928 is a study of Type 1 Diabetes and Celiac Disease that is actively recruiting participants, run by Sanford Health. The registered enrollment target is 33,000 participants, above the 600-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (5400% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477928, a study of Type 1 Diabetes and Celiac Disease, is actively recruiting participants, sponsored by Sanford Health.
- RECRUITING
- Registry status
- 33,000 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
1. The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires. 2. Of those who consented to be in the study, the percentage who went on to obtain the initial sample. 3. Of the total samples collected, percentage that were valid and results received. 4. The percentage of subjects who complete their \~60 month visit by their 6th birthday.
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 |
What NCT04477928 shows while recruiting
NCT04477928 is an observational study that tracks outcomes without assigning an intervention. Its 33,000 participants enrollment target places it among the larger protocols in the corpus, above the 600-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (5400% higher).
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.
NCT04477928 reports a single indexed study location in North Dakota, Minnesota, South Dakota.
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.
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).
Who is sponsoring clinical trial NCT04477928?
This trial is sponsored by Sanford Health, which has 34 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04477928's enrollment target sits among peer trials
33,000 2nd of 198 the highest of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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