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Using the mylife CamAPS FX with the Dexcom G6 for people with type 1 diabetes 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 · NCT07048795

This project will see if using the mylife CamAPS FX hybrid closed-loop system paired with the Dexcom G6 sensor improves blood sugar control over one year in people with type 1 diabetes in France.

Quick facts

Study typeObservational
Enrollment125 (estimated)
SexAll
Sponsormylife Diabetes Care AG (industry)
Locations20 sites (Amiens and 19 other locations)
Trial IDNCT07048795 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-interventional, multicenter post-market follow-up conducted in France among about 125 people with type 1 diabetes (approximately 100 adults and 25 minors) who start using the mylife CamAPS FX hybrid closed-loop system with the Dexcom G6 sensor. The main outcome is change in glycemic control after one year of real-life use. Secondary measures include patient-reported outcomes (quality of life, treatment satisfaction, fear of hypoglycemia, sleep quality), system-related complications, hybrid closed-loop usage rates, and device usage parameters such as Boost/Ease-Off mode use and alarm patterns. The system is CE-marked and the study follows EU MDR requirements as a non-invasive Post-Market Clinical Follow-up (category 4.1).

Who should consider this trial

Good fit: People with type 1 diabetes in France who are starting the mylife CamAPS FX hybrid closed-loop paired with a Dexcom or Abbott sensor (with at least 14 days and ~70% sensor coverage prior) and who can provide consent and complete online questionnaires are ideal candidates.

Not a fit: People who are not using the CamAPS FX system or compatible sensors, who cannot complete follow-up or questionnaires, or who do not receive care at participating French centers are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, the results could show better average glucose control and patient experience with the system, supporting wider clinical use and reimbursement.

How similar studies have performed: Previous clinical and real-world studies of hybrid closed-loop systems, including published data on CamAPS FX and other platforms, have generally shown improved time-in-range and reduced hypoglycemia, so this study builds on existing evidence in a real-life setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 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.
* 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).

Where this trial is running

Amiens and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetes Type 1, Diabetes Mellitus, Type 1, Real-life use, mylife CamAPS FX, YpsoPump, Hybrid closed loop

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.