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

Recruiting now

Conditions studied: Diabetes Type 1

In brief

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. The study will involve approximately 125 participants (including 100 adults and 25 minors) across 22 centers in France. Patients will be followed up for 12 months.

Key facts

Study ID

NCT07048795

Run by

mylife Diabetes Care AG

People needed

125

Starts

2025-12-11

Expected to finish

2027-12-01

Last updated by the study team

2026-07-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• CHU Amiens — Amiens, France (enrolling)
• Hôtel Dieu-Pédiatrie — Angers, France (enrolling)
• CH Victor Dupouy — Argenteuil, France (enrolling)
• Hôpital Bois Guillaume — Bois-Guillaume, France (enrolling)
• CHU de Bordeaux — Bordeaux, France (enrolling)
• CHU Brest - Hôpital La Cavale Blanche — Brest, France (enrolling)
• Hôpital Femme Mère Enfant Lyon — Bron, France (enrolling)
• CHU Grenoble Alpes — Grenoble, France (enrolling)
• Groupe Hospitalier de la Rochelle Ré Aunis — La Rochelle, France (enrolling)
• Hospices Civils de Lyon DIAB-Ecare — Lyon, France (enrolling)
• Hôpital Européen — Marseille, France (enrolling)
• Hôpital Europeen Georges Pompidou — Paris, France (enrolling)
• Hôpital Universitaire Necker Enfants Malades — Paris, France (enrolling)
• Groupe hospitalier Bichat Claude Bernard — Paris, France (enrolling)
• CH Périgueux — Périgueux, France (enrolling)
• CHU Poitiers — Poitiers, France (enrolling)
• Hôpital NOVO, Site Pontoise — Pontoise, France (enrolling)
• CHU Toulouse — Toulouse, France (enrolling)
• Clinique Pasteur — Toulouse, France (enrolling)
• CHRU Nancy-Hôpitaux de Brabois Adultes — Vandœuvre-lès-Nancy, France (enrolling)
• CH Bretagne Atlantique — Vannes, France (enrolling)
• Hôpital Robert Schuman-UNEOS — Vantoux, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.