Status:
RECRUITING
Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
Lead Sponsor:
mylife Diabetes Care AG
Collaborating Sponsors:
Qualees SAS
CamDiab Ltd
Conditions:
Diabetes Type 1
Eligibility:
All Genders
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 (T...
Detailed Description
This study, called EPICAM-PMCF-G6, is part of a Post-Market Clinical Follow-up (PMCF) requested by the French Health Technology Assessment Committee (CNEDiMTS), following the listing of the System for...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Key Trial Info
Start Date :
December 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07048795
Start Date
December 11 2025
End Date
December 1 2027
Last Update
March 3 2026
Active Locations (20)
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1
CHU Amiens
Amiens, France, 80054
2
Hôtel Dieu-Pédiatrie
Angers, France, 49933
3
CH Victor Dupouy
Argenteuil, France, 95107
4
Hôpital Bois Guillaume
Bois-Guillaume, France, 76230