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
mylife Diabetes Care AG
125 participants
Dec 11, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Patients with type 1 diabetes who have been using a Dexcom or Abbott Libre glucose sensor (any model) for at least 14 days prior to the date of installation of the mylife YpsoPump, with at least 70% coverage, under the same sensor.
- Patient for whom the diabetes specialist decides to initiate the mylife CamAPS FX hybrid closed loop.
- 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 Criteria9
- 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.
- Patients participating or having participated in a clinical trial in the previous month that prevents them from participating in other studies.
- 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 a concomitant condition or treatment that alters glucose metabolism and that, in the investigator's judgment, is likely to have a significant impact on glycemic control;
- Patient whose follow-up cannot be carried out by the centre (relocation planned within 12 months of inclusion).
Interventions
No intervention
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07048795