CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
t:slim X2 with Control-IQ Technology & Dexcom G6 CGM +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03591354
NCT03591354N/ACompleted
CompareCT.gov

An Extension Study of t:Slim X2 With Control-IQ Technology

University of Virginia·interventional·Posted Jul 19, 2018·Updated Aug 31, 2022

In Brief

A clinical study evaluating t:slim X2 with Control-IQ Technology & Dexcom G6 CGM and t:slim X2 with Basal-IQ & Dexcom G6 CGM for Type 1 Diabetes Mellitus. Completed, enrolled 164 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostics GmbH

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 19, 2018
Enrollment StartJan 17, 2019
Primary CompletionFeb 28, 2020
Study CompletionMar 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.0 years ago

Interventions

t:slim X2 with Control-IQ Technology & Dexcom G6 CGMdevice

Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology \& Dexcom G6 CGM for 3 months.

t:slim X2 with Basal-IQ & Dexcom G6 CGMdevice

Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.