NCT07211126

The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.

Detailed description

This post-market surveillance study is a single-arm, prospective cohort study. It is designed to: 1. Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis). 2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation. 3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life. 4. Describe the real-world use of the Control-IQ System.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)	Participants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months.

Timeline

• Start date: 2026-03-03
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-10-07
• Last updated: 2026-04-02

Locations

13 sites across 1 country: France

Regulatory

• FDA-regulated device study