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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Page 1 of 5 (20 locations)

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