Real-World Study of Control-IQ System Use for Type 1 Diabetes Management Evaluating Safety, Blood Sugar Control, and Quality of Life in France

What this Trial Is About

This research aims to evaluate the ongoing safety, performance, and quality of life associated with using the Control-IQ system in people with type 1 diabetes. The study is a post-market surveillance, single-arm, prospective cohort design conducted in France and sponsored by Tandem Diabetes Care, Inc. It focuses on the first 12 months of real-world use of the Control-IQ system across all approved populations. Participants will use the tslim X2 insulin pump with Control-IQ technology combined with Dexcom G6 or G7 continuous glucose monitoring sensors. They will follow standard care practices while using the system continuously for 12 months. The study observes the devices safety by measuring rates of severe metabolic complications like diabetic ketoacidosis and severe hypoglycemia during this period. During the study, participants will provide data on their blood glucose levels and device use, while also completing questionnaires about their treatment satisfaction, system usability, quality of life, and fear of hypoglycemic events. Researchers will monitor glycemic control outcomes such as time in target glucose range and time spent above or below specified glucose levels. The study follows participants for one year, including tracking device usage and collecting clinical data according to usual care standards.

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