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

Launched by YPSOMED DIABETES CARE AG · Jun 24, 2025

Keywords

ClinConnect Summary

This study is looking at how well the mylife CamAPS FX system, combined with the DEXCOM G6 continuous glucose monitor, helps people with type 1 diabetes manage their blood sugar levels in everyday life. The mylife CamAPS FX is a smart insulin delivery system that works with the glucose sensor to adjust insulin doses automatically. Researchers want to see how this system affects blood sugar control over one year and how it influences quality of life, including treatment satisfaction, fear of low blood sugar, and sleep quality.

The study will include about 125 participants in France, both adults and children with type 1 diabetes, who are already using the mylife Ypsopump and the Dexcom G6 sensor regularly. To join, patients must have been using these devices for at least two weeks and have their doctor decide that starting the CamAPS FX system is right for them. Participants will continue their usual diabetes care and visit their doctor three times over the year to check progress and share their experiences through questionnaires. The study will collect data from their insulin pumps and glucose sensors to better understand how the system is used and its benefits in real life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with Type 1 Diabetes using the mylife Ypsopump and the Dexcom G6 CGM sensor for at least 14 days prior to the V0 visit.
• • Patient having used continuous glucose measurement with the Dexcom G6 CGM sensor at least 70% of the time during the 14-day period prior to the V0 visit.
• • Patient for whom the diabetes specialist decides to initiate the mylife CamAPS FX hybrid closed loop in accordance with the reimbursement criteria applicable at the time of inclusion in the study.
• • Patient who received the information sheets and gave their consent to participate in the study and to the processing of their personal data.
• • Adult patient who signed an informed consent form to participate in the study or minor patient whose parents signed an informed consent form for their child's participation in the study.
• • Adult patient, minor patient old enough to complete the questionnaires or parent of a minor patient able to read and understand French.
• • Adult patient / minor patient capable to complete the questionnaires or parent of a minor patient who agrees to complete the online self-questionnaires.
• Exclusion Criteria:
• • Patient who used a hybrid closed-loop system, a fully closed-loop system, or a do-it-yourself loop system, regardless of the brand or model, within the past 6 months.
• • Patient taking part or having taken part in the previous month in a diabetes trial.
• • Patient or parent unable to give consent.
• • Protected Patient (subject to a legal protection measure: guardianship, curatorship or legal safeguard).
• • Patient with a contraindication to the prescription of the mylife CamAPS FX hybrid closed-loop ( according to the Instructions For Use, IFU).
• • Patient with an unresolved skin condition in the area of sensor placement and/or in the tubing placement area (e.g. psoriasis, dermatitis herpetiformis, rash, staphylococcal infection).
• • Patient with unstable diabetic retinopathy requiring laser treatment.
• • Patient with associated pathology or treatment that alters glucose metabolism.
• • Patient whose follow-up cannot be carried out by the centre (relocation planned within 12 months of inclusion).