NCT07048795

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

Impact de l'Utilisation du système Mylife CamAPS FX associé au Capteur DEXCOM G6 Sur le contrôle glycémique et la qualité de Vie de Patients DT1, en Vie réelle, en France

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: mylife Diabetes Care AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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 (e.g., Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, alarms). The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France. Endocrinologists / diabetes specialists will monitor participants over the 12-month period after they start using the system and collect data at the three data collection time points.

Detailed description

This study, called EPICAM-PMCF-G6, is part of a Post-Market Clinical Follow-up (PMCF) requested by the French Health Technology Assessment Committee (CNEDiMTS), following the listing of the System for reimbursement under the national healthcare system in France. This study is carried following the European Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) and thus falls into the category of clinical investigations (CI) of Medical Devices (MD). The System evaluated in this clinical investigation bears CE-marking (market approval according to the MDR) and is used in accordance with its intended purpose. As this study does not involve any invasive or burdensome procedures, it is classified as a non-invasive PMCF investigation of category 4.1. according to the French National Agency for the Safety of Medicines and Health Products (ANSM).

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
OTHER	No Intervention: Observational Cohort	No intervention

Timeline

• Start date: 2025-12-11
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2025-07-02
• Last updated: 2026-03-03

Locations

20 sites across 1 country: France