CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 168 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/NCT03563313
NCT03563313N/ACompleted
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A Pivotal Study of t:Slim X2 With Control-IQ Technology

University of Virginia·interventional·Posted Jun 20, 2018·Updated Apr 28, 2020

In Brief

A clinical study evaluating t:slim X2 with Control-IQ Technology & Dexcom G6 CGM and Sensor-augmented pump (SAP) for Type 1 Diabetes Mellitus. Completed, enrolled 168 participants across 7 sites.

Detailed Summary

The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 20, 2018
Enrollment StartJun 28, 2018
Primary CompletionApr 8, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.0 years ago

Interventions

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

Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.

Sensor-augmented pump (SAP)device

Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.