Study of the mylife CamAPS FX Hybrid Closed-Loop System with DEXCOM G6 Sensor Evaluating Impact on Glycemic Control and Quality of Life in Type 1 Diabetes Patients in France

What this Trial Is About

Researchers are studying the use of the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the Dexcom G6 Continuous Glucose Monitoring sensor in people with type 1 diabetes T1D in France. This observational study aims to evaluate the systems impact on blood sugar control under real-life conditions over one year. It also explores participant experiences related to quality of life, treatment satisfaction, fear of low blood sugar, and sleep quality while tracking any complications related to the system. Participants include both adults and minors starting use of the system as part of their usual diabetes care. The study follows them for 12 months, collecting data on blood sugar control and system usage. There is no experimental treatment given instead, the study observes how the system performs when used in daily life by about 125 participants across multiple centers in France. Throughout the study, participants will complete self-reported questionnaires on quality of life and treatment experience at baseline, 3 months, and 12 months. Blood sugar data is gathered continuously from the glucose monitoring sensor to assess changes in time spent in target ranges and other glucose metrics. Safety is monitored by recording any adverse events related to the system. The study aims to understand how the system affects diabetes management and patient well-being over one year of use.

Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France