Using the mylife CamAPS FX with the Dexcom G6 for people with type 1 diabetes in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• CHU Amiens
  Amiens, France Recruiting
• Hôtel Dieu-Pédiatrie
  Angers, France Recruiting
• CH Victor Dupouy
  Argenteuil, France Recruiting
• Hôpital Bois Guillaume
  Bois-Guillaume, France Recruiting
• CHU de Bordeaux
  Bordeaux, France Recruiting
• CHU Brest - Hôpital La Cavale Blanche
  Brest, France Recruiting

Study contacts

• Study coordinator: Ingo Braun, Dr.
• Email: clinical-studies@mylife-diabetescare.com
• Phone: +41582347132

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.