Follows people with type 1 diabetes using an automated insulin system
Follows type 1 diabetes patients using an automated insulin and glucose sensor system.
Plain-language title generated from the registry record
Registry title: Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
Key facts
- Where
- Amiens, Angers, Argenteuil, Bois-Guillaume, Bordeaux, Brest, Bron, Grenoble, La Rochelle, Lyon, Marseille, Paris, Périgueux, Poitiers, Pontoise, Toulouse, Vandœuvre-lès-Nancy, Vannes, and Vantoux, FranceSee the 22 sites
Where in France
- CHU AmiensAmiens, FranceTaking people
- Hôtel Dieu-PédiatrieAngers, FranceTaking people
- CH Victor DupouyArgenteuil, FranceTaking people
- Hôpital Bois GuillaumeBois-Guillaume, FranceTaking people
- CHU de BordeauxBordeaux, FranceTaking people
- CHU Brest, Hopital La Cavale BlancheBrest, FranceTaking people
- Hôpital Femme Mère Enfant LyonBron, FranceTaking people
- CHU Grenoble AlpesGrenoble, FranceTaking people
- Groupe Hospitalier de la Rochelle Re-AunisLa Rochelle, FranceTaking people
- Hospices Civils de Lyon DIAB-EcareLyon, FranceTaking people
- Hopital EuropeenMarseille, FranceTaking people
- Groupe Hospitalier Bichat Claude BernardParis, FranceTaking people
- Hôpital Européen Georges PompidouParis, FranceTaking people
- Hôpital Universitaire Necker Enfants MaladesParis, FranceTaking people
- CH PérigueuxPérigueux, FranceTaking people
- CHU PoitiersPoitiers, FranceTaking people
- Hôpital NOVO, Site PontoisePontoise, FranceTaking people
- CHU ToulouseToulouse, FranceTaking people
- Clinique PasteurToulouse, FranceTaking people
- CHRU Nancy-Hôpitaux de Brabois AdultesVandœuvre-lès-Nancy, FranceTaking people
- CH Bretagne AtlantiqueVannes, FranceTaking people
- Hôpital Robert Schuman-UNEOSVantoux, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- mylife Diabetes Care AG
- Trial code
- NCT07048795
- Record updated
- 9 July 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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: Patients participating or having participated in a clinical trial in the previous month that prevents them from participating in other studies; 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 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 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 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 unstable diabetic retinopathy requiring laser treatment; Patient whose follow-up cannot be carried out by the centre (relocation planned within 12 months of inclusion).