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Taking people in FranceNo phase

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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