CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 183 enrolled
Drug / intervention
t:slim X2 insulin pump with Control-IQ technology 1.5device
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/NCT05403502
NCT05403502N/ACompleted

Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

Tandem Diabetes Care, Inc.·interventional·Posted Jun 3, 2022·Updated Jul 26, 2024

In Brief

A clinical study evaluating t:slim X2 insulin pump with Control-IQ technology 1.5 for Type 1 Diabetes. Completed, enrolled 183 participants across 13 sites.

Detailed Summary

Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 3, 2022
Enrollment StartAug 31, 2022
Primary CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.1 years ago

Interventions

t:slim X2 insulin pump with Control-IQ technology 1.5device

t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.