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NCT07048795Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

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. 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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
125 (estimated)
First submitted
24 Jun 2025
Start date
11 Dec 2025
Primary completion date
31 Mar 2027
Lead sponsor
mylife Diabetes Care AG
NCT number
NCT07048795

What you commit to

  • Study type: Observational
  • Planned participants: 125
  • From 11 Dec 2025 to the primary completion date, 31 Mar 2027
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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).

Lab values

  • 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;

Other

  • 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).

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
Hôtel Dieu-Pédiatrie
Coordinator of this site? Confirm its status
AngersFranceRecruiting
CH Victor Dupouy
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ArgenteuilFranceRecruiting
Hôpital Bois Guillaume
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Bois-GuillaumeFranceRecruiting
CHU de Bordeaux
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BordeauxFranceRecruiting
CHU Brest, Hopital La Cavale Blanche
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BrestFranceRecruiting
Hôpital Femme Mère Enfant Lyon
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BronFranceRecruiting
CHU Grenoble Alpes
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GrenobleFranceRecruiting
Groupe Hospitalier de la Rochelle Re-Aunis
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La RochelleFranceRecruiting
Hospices Civils de Lyon DIAB-Ecare
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LyonFranceRecruiting
Hopital Europeen
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MarseilleFranceRecruiting
Groupe Hospitalier Bichat Claude Bernard
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ParisFranceRecruiting
Hôpital Universitaire Necker Enfants Malades
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ParisFranceRecruiting
Hôpital Européen Georges Pompidou
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ParisFranceRecruiting
CH Périgueux
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PérigueuxFranceRecruiting
CHU Poitiers
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PoitiersFranceRecruiting
Hôpital NOVO, Site Pontoise
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PontoiseFranceRecruiting
CHU Toulouse
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ToulouseFranceRecruiting
Clinique Pasteur
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ToulouseFranceRecruiting
CHRU Nancy-Hôpitaux de Brabois Adultes
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Vandœuvre-lès-NancyFranceRecruiting
CH Bretagne Atlantique
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VannesFranceRecruiting
Hôpital Robert Schuman-UNEOS
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VantouxFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.