NCT05403502

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 6 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80 years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump. After a run-in period, participants will use the study pump with Control-IQ technology 1.5 and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be enrolled so at least 160 complete the study.

Conditions

• Type 1 Diabetes

Interventions

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

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-08-02
• Completion: 2023-08-02
• First posted: 2022-06-03
• Last updated: 2024-07-26
• Results posted: 2024-07-26

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study