Follows people with type 1 diabetes using an automated insulin system
Follows type 1 diabetes patients using an automated insulin and glucose sensor system.
Key facts
- Who runs it
- mylife Diabetes Care AG
- 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
- Trial code
- Registry title
- Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
- Status
- Recruiting
- People taking part
- 125 people, planned
- Started
- 11 Dec 2025
- Expected to end
- Dec 2027
- Type of study
- Observational
- Treatments tested
- No Intervention: Observational Cohort
- Record updated
- 9 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults and children with type 1 diabetes whose doctor has decided to start the mylife CamAPS FX hybrid closed-loop system with the DEXCOM G6 sensor. They are followed for 12 months.
- Age
- Adults and minors. Minors must be old enough to fill in the questionnaires, or a parent must do it. No exact age range is given.
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes.
- Earlier treatment
- Must have used a Dexcom or Abbott Libre glucose sensor for at least 14 days, with at least 70% coverage, under the same sensor. Must not have used any closed-loop system in the past 6 months.
Main reasons for not taking part
- Used a hybrid, fully closed-loop or do-it-yourself loop system in the past 6 months
- Took part in a clinical trial in the previous month that prevents other studies
- Unresolved skin condition where the sensor or tubing is placed
- Unstable diabetic retinopathy needing laser treatment
- Moving away within 12 months so follow-up is not possible
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in France
- CHU AmiensAmiens, FranceContact: Ingo Braun, Dr.Taking people
- Hôtel Dieu-PédiatrieAngers, FranceContact: Ingo Braun, Dr.Taking people
- CH Victor DupouyArgenteuil, FranceContact: Ingo Braun, Dr.Taking people
- Hôpital Bois GuillaumeBois-Guillaume, FranceContact: Ingo Braun, Dr.Taking people
- CHU de BordeauxBordeaux, FranceContact: Ingo Braun, Dr.Taking people
- CHU Brest, Hopital La Cavale BlancheBrest, FranceContact: Ingo Braun, Dr.Taking people
- Hôpital Femme Mère Enfant LyonBron, FranceContact: Ingo Braun, Dr.Taking people
- CHU Grenoble AlpesGrenoble, FranceContact: Ingo Braun, Dr.Taking people
- Groupe Hospitalier de la Rochelle Re-AunisLa Rochelle, FranceContact: Ingo Braun, Dr.Taking people
- Hospices Civils de Lyon DIAB-EcareLyon, FranceContact: Ingo Braun, Dr.Taking people
- Hopital EuropeenMarseille, FranceContact: Ingo Braun, Dr.Taking people
- Groupe Hospitalier Bichat Claude BernardParis, FranceContact: Ingo Braun, Dr.Taking people
- Hôpital Européen Georges PompidouParis, FranceContact: Ingo Braun, Dr.Taking people
- Hôpital Universitaire Necker Enfants MaladesParis, FranceContact: Ingo Braun, Dr.Taking people
- CH PérigueuxPérigueux, FranceContact: Ingo Braun, Dr.Taking people
- CHU PoitiersPoitiers, FranceContact: Ingo Braun, Dr.Taking people
- Hôpital NOVO, Site PontoisePontoise, FranceContact: Ingo Braun, Dr.Taking people
- CHU ToulouseToulouse, FranceContact: Ingo Braun, Dr.Taking people
- Clinique PasteurToulouse, FranceContact: Ingo Braun, Dr.Taking people
- CHRU Nancy-Hôpitaux de Brabois AdultesVandœuvre-lès-Nancy, FranceContact: Ingo Braun, Dr.Taking people
- CH Bretagne AtlantiqueVannes, FranceContact: Ingo Braun, Dr.Taking people
- Hôpital Robert Schuman-UNEOSVantoux, FranceContact: Ingo Braun, Dr.Taking people
About the trial
What the trial wants to find out
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
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.
The group in the trial
- Participants with type 1 diabetes initiating the hybrid closed-loop system
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: No Intervention: Observational Cohort
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Follows people with type 1 diabetes using an automated insulin systemGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 July 2026