Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France

Last updated: February 27, 2026
Sponsor: mylife Diabetes Care AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Treatment

No Intervention: Observational Cohort

Clinical Study ID

NCT07048795
2024-A00207-40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with type 1 diabetes who have been using a Dexcom or Abbott Libre glucosesensor (any model) for at least 14 days prior to the date of installation of themylife YpsoPump, with at least 70% coverage, under the same sensor.

  • Patient for whom the diabetes specialist decides to initiate the mylife CamAPS FXhybrid closed loop.

  • Patient who received the information sheets and gave their consent to participate inthe study and to the processing of their personal data.

  • Adult patient who signed an informed consent form to participate in the study orminor patient whose parents signed an informed consent form for their child'sparticipation in the study.

  • Adult patient, minor patient old enough to complete the questionnaires or parent ofa minor patient able to read and understand French.

  • Adult patient / minor patient capable to complete the questionnaires or parent of aminor patient who agrees to complete the online self-questionnaires.

Exclusion

Exclusion Criteria:

  • Patient who used a hybrid closed-loop system, a fully closed-loop system, or ado-it-yourself loop system, regardless of the brand or model, within the past 6months.

  • Patients participating or having participated in a clinical trial in the previousmonth that prevents them from participating in other studies.

  • Patient or parent unable to give consent.

  • Protected Patient (subject to a legal protection measure: guardianship, curatorshipor legal safeguard).

  • Patient with a contraindication to the prescription of the mylife CamAPS FX hybridclosed-loop ( according to the Instructions For Use, IFU).

  • Patient with an unresolved skin condition in the area of sensor placement and/or inthe 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 andthat, in the investigator's judgment, is likely to have a significant impact onglycemic control;

  • Patient whose follow-up cannot be carried out by the centre (relocation plannedwithin 12 months of inclusion).

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: No Intervention: Observational Cohort
Phase:
Study Start date:
December 11, 2025
Estimated Completion Date:
December 31, 2027

Study 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 reimbursement under the national healthcare system in France.

This study is carried following the European Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) and thus falls into the category of clinical investigations (CI) of Medical Devices (MD).

The System evaluated in this clinical investigation bears CE-marking (market approval according to the MDR) and is used in accordance with its intended purpose. As this study does not involve any invasive or burdensome procedures, it is classified as a non-invasive PMCF investigation of category 4.1. according to the French National Agency for the Safety of Medicines and Health Products (ANSM).

Connect with a study center

  • CHU Amiens

    Amiens, 80054
    France

    Site Not Available

  • CHU Amiens

    Amiens 3037854, 80054
    France

    Active - Recruiting

  • Hôtel Dieu-Pédiatrie

    Angers, 49933
    France

    Site Not Available

  • Hôtel Dieu-Pédiatrie

    Angers 3037656, 49933
    France

    Active - Recruiting

  • CH Victor Dupouy

    Argenteuil, 95107
    France

    Site Not Available

  • CH Victor Dupouy

    Argenteuil 3037044, 95107
    France

    Active - Recruiting

  • Hôpital Bois Guillaume

    Bois-Guillaume 3032025, 76230
    France

    Active - Recruiting

  • Hôpital Bois Guillaume

    Bois-guillaume, 76230
    France

    Site Not Available

  • CHU Brest - Hôpital La Cavale Blanche

    Brest, 29609
    France

    Site Not Available

  • CHU Brest - Hôpital La Cavale Blanche

    Brest 3030300, 29609
    France

    Active - Recruiting

  • Hôpital Femme Mère Enfant Lyon

    Bron, 69677
    France

    Site Not Available

  • Hôpital Femme Mère Enfant Lyon

    Bron 3029931, 69677
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    Grenoble, 38042
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble 3014728, 38042
    France

    Active - Recruiting

  • Groupe Hospitalier de la Rochelle Ré Aunis

    La Rochelle, 17019
    France

    Site Not Available

  • Groupe Hospitalier de la Rochelle Ré Aunis

    La Rochelle 3006787, 17019
    France

    Active - Recruiting

  • Hospices Civils de Lyon DIAB-Ecare

    Lyon, 69008
    France

    Site Not Available

  • Hospices Civils de Lyon DIAB-Ecare

    Lyon 2996944, 69008
    France

    Active - Recruiting

  • Hôpital Européen

    Marseille, 13003
    France

    Site Not Available

  • Hôpital Européen

    Marseille 2995469, 13003
    France

    Active - Recruiting

  • Groupe hospitalier Bichat Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Hôpital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Groupe hospitalier Bichat Claude Bernard

    Paris 2988507, 75018
    France

    Active - Recruiting

  • Hôpital Europeen Georges Pompidou

    Paris 2988507, 75015
    France

    Active - Recruiting

  • Hôpital Universitaire Necker Enfants Malades

    Paris 2988507, 75015
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • CHU Poitiers

    Poitiers 2986495, 86021
    France

    Site Not Available

  • Hôpital NOVO, Site Pontoise

    Pontoise, 95300
    France

    Site Not Available

  • Hôpital NOVO, Site Pontoise

    Pontoise 2986140, 95300
    France

    Active - Recruiting

  • CH Périgueux

    Périgueux, 24000
    France

    Site Not Available

  • CH Périgueux

    Périgueux 2987967, 24000
    France

    Active - Recruiting

  • CHU Reims American Memorial Hospital

    Reims, 51092
    France

    Site Not Available

  • CHU Reims American Memorial Hospital

    Reims 2984114, 51092
    France

    Site Not Available

  • CHU Toulouse

    Toulouse 2972315, 31059
    France

    Site Not Available

  • CHRU Nancy-Hôpitaux de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

  • CHRU Nancy-Hôpitaux de Brabois Adultes

    Vandœuvre-lès-Nancy 2970797, 54511
    France

    Active - Recruiting

  • CH Bretagne Atlantique

    Vannes, 56017
    France

    Site Not Available

  • CH Bretagne Atlantique

    Vannes 2970777, 56017
    France

    Active - Recruiting

  • Hôpital Robert Schuman-UNEOS

    Vantoux, 57070
    France

    Site Not Available

  • Hôpital Robert Schuman-UNEOS

    Vantoux 2970764, 57070
    France

    Active - Recruiting

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