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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: Completed NA study, sponsored by University of Virginia.
NCT03591354 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 164 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
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 |
What the finished NCT03591354 record still lists
NCT03591354 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03591354's enrollment target sits among peer trials
164 626th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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