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

mylife Diabetes Care AG

Status: Enrolling

Conditions: Diabetes Type 1

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07048795

2024-A00207-40

Details and patient eligibility

About

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.

Full 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).

Enrollment: 125 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

125 participants in 1 patient group

Participants with type 1 diabetes initiating the hybrid closed-loop system studied

Description:

Participants (adults and minors) with type 1 diabetes (T1D) initiating the mylife CamAPS FX system combined with the Dexcom G6 sensor, under real-life management conditions

Treatment:

Other: No Intervention: Observational Cohort