Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
EPICAM-G6
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
1 other identifier
observational
125
1 country
20
Brief Summary
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 (e.g., Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, alarms). The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France. Endocrinologists / diabetes specialists will monitor participants over the 12-month period after they start using the system and collect data at the three data collection time points.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedStudy Start
First participant enrolled
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 3, 2026
February 1, 2026
1.2 years
June 24, 2025
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Time in Range (TIR)
Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)
Baseline and 3 months
Secondary Outcomes (17)
Change in Time in Range (TIR)
Baseline and 12 months
Change in Time In Tight Range (TITR)
Baseline, 3 and 12 months
Change in Time Above Range (TAR)
Baseline, 3 months, and 12 months
Change in Time Below Range (TBR)
Baseline, 3 and 12 months
Change in average glucose levels from CGM sensor data
Baseline, 3 months and 12 months
- +12 more secondary outcomes
Study Arms (1)
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
Interventions
No intervention
Eligibility Criteria
The study population will be recruited from 20 French participating centers, which are defined as insulin pump initiation hospital centers according to the definition of the Francophone Diabetic Society.
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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- mylife Diabetes Care AGlead
- Qualees SAScollaborator
- CamDiab Ltdcollaborator
Study Sites (20)
CHU Amiens
Amiens, 80054, France
Hôtel Dieu-Pédiatrie
Angers, 49933, France
CH Victor Dupouy
Argenteuil, 95107, France
Hôpital Bois Guillaume
Bois-Guillaume, 76230, France
CHU Brest - Hôpital La Cavale Blanche
Brest, 29609, France
Hôpital Femme Mère Enfant Lyon
Bron, 69677, France
CHU Grenoble Alpes
Grenoble, 38042, France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, 17019, France
Hospices Civils de Lyon DIAB-Ecare
Lyon, 69008, France
Hôpital Européen
Marseille, 13003, France
Hôpital Europeen Georges Pompidou
Paris, 75015, France
Hôpital Universitaire Necker Enfants Malades
Paris, 75015, France
Groupe hospitalier Bichat Claude Bernard
Paris, 75018, France
CH Périgueux
Périgueux, 24000, France
CHU Poitiers
Poitiers, 86021, France
Hôpital NOVO, Site Pontoise
Pontoise, 95300, France
CHU Toulouse
Toulouse, 31059, France
CHRU Nancy-Hôpitaux de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
CH Bretagne Atlantique
Vannes, 56017, France
Hôpital Robert Schuman-UNEOS
Vantoux, 57070, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel SONNET, MD
Centre Hospitalier Universitaire de Brest - Cavale Blanche Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2025
First Posted
July 2, 2025
Study Start
December 11, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
In accordance with the General Data Protection Regulation and French data protection laws the presentation of the results derived from data processing shall under no circumstances allow the direct or indirect identification of individuals participating in the study. In the event of publication of the study findings in a scientific journal, access to the data by an independent expert - including one appointed by a scientific publisher - shall only be granted through the interface provided or designated by the Data Controller, solely for the purpose of verifying or reproducing the analyses, and exclusively under the conditions defined for secure consultation and data handling. The study is a non-interventional trial.