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

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, meal announcements). The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France. The study is "non-interventional", which means that care and treatment are carried out as per the routine standard treatment by the endocrinologists / diabetes specialists. The decision to initiate treatment with the System is made independently of the study participation. Participants in the study will be followed up as part of routine care at 3 visits coinciding with the three data collection time points in the study: at inclusion (baseline, Visit 0), at around 3 months (Visit 1), and around 12 months (Visit 2) after activation of the hybrid closed-loop mode. 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. Continuous glucose sensor (CGM) and insulin pump data will also be collected. Participants will also be asked at the three data collection time points to complete online questionnaires on their experience with diabetes.

Eligibility

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).

Conditions2

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