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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.

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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

FieldValue
Enrollment Target 164 participants
Start Date 2019-01-17
Est. Completion 2020-03-09
Phase NA

Sponsor

University of Virginia

449 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.