CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 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/NCT03844789
NCT03844789N/ACompleted
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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology

University of Virginia·interventional·Posted Feb 18, 2019·Updated Apr 10, 2023

In Brief

A clinical study evaluating t:slim X2 with Control-IQ Technology & Dexcom G6 CGM and Control Group for Type 1 Diabetes Mellitus. Completed, enrolled 101 participants across 4 sites.

Detailed Summary

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsTandem Diabetes Care, Inc., DexCom, Inc., Jaeb Center for Health Research

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 18, 2019
Enrollment StartJun 6, 2019
Primary CompletionDec 20, 2019
Study CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.4 years ago

Interventions

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

Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM

Control Groupdevice

Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.