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NCT03591354 · ClinicalTrials.gov registry record · NA
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 164
- Enrollment target
NCT03591354 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 164 participants.
The verdict
NCT03591354, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 164 participants
- Enrollment target
Study Summary
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.
Interventions
- DEVICE t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
- DEVICE t:slim X2 with Basal-IQ & Dexcom G6 CGM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2020-03-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03591354
The ClinicalTrials.gov registry entry for NCT03591354 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which t:slim X2 with Control-IQ Technology & Dexcom G6 CGM is the first listed.
NCT03591354 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03591354 about?
NCT03591354 is a clinical study titled "The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)". This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will ...
What is the current status of trial NCT03591354?
This trial is currently completed. It is a NA study. The enrollment target is 164 participants. The study started on 2019-01-17. Estimated completion is 2020-03-09.
What interventions are being tested in trial NCT03591354?
The interventions under investigation include: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM (DEVICE), t:slim X2 with Basal-IQ & Dexcom G6 CGM (DEVICE).
Who is sponsoring clinical trial NCT03591354?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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