CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Hybrid Closed Loop (HCL) +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/NCT03804983
NCT03804983N/ACompleted
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Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

University of Virginia·interventional·Posted Jan 15, 2019·Updated Aug 1, 2024

In Brief

A clinical study evaluating Hybrid Closed Loop (HCL) and Control-IQ with MyTDI for Type 1 Diabetes Mellitus. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsTandem Diabetes Care, Inc., DexCom, Inc.

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 15, 2019
Enrollment StartJan 15, 2019
Primary CompletionFeb 16, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.5 years ago

Interventions

Hybrid Closed Loop (HCL)device

Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Control-IQ with MyTDIdevice

Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.