Clinical trials

The goal of this observational study is to learn how glucose control changes over one year in people with type 1 diabetes who use the myLoop with CamAPS FX and Freestyle Libre 3 or FreeStyle Libre 3 Plus during usual care in France. The main question it aims to answer is: • How time in range (TIR) changes after one year of use. Time in range is the percentage of time glucose levels stay within the target range. As secondary aims, the study aims to answer how other glucose measures (other than TIR, for example Time Above / Below Range) change at six months and one year. Participants who are prescribed the myLoop with CamAPS FX during usual care for Type 1 Diabetes will: * agree to have their routine clinical data on diabetes management and related complications before and after starting therapy with myLoop with CamAPS FX used for this study. * answer online survey questions about their quality of life, use of the device and features and treatment satisfaction at six months and one year.

This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France. The study is conducted among participants with type 1 diabetes (T1D) using the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring (CGM) sensor (the System). The main objective of the study is to evaluate, under real-life conditions, the impact of the System on glycemic control in participants with T1D after one year of use. Secondary objectives include assessing participant-reported outcomes, such as quality-of-life, treatment satisfaction, fear of hypoglycemia, and sleep quality, describing complications related to the system, the rate of hybrid closed-loop usage over one year, and analyzing system usage parameters. The study will involve approximately 125 participants (including 100 adults and 25 minors) across 22 centers in France. Patients will be followed up for 12 months.