Ireland
--:--IST
Recruiting Observational

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

NCT07048795 · tracked via the Priya Life Science France tracker
Sponsor
mylife Diabetes Care AG
Phase
Observational
Started
2025-12-11
Last updated
2026-07-09

Condition(s) studied

Diabetes Type 1

Investigational drug(s) / intervention(s)

No Intervention: Observational Cohort

No Intervention: Observational Cohort: No intervention

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.

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Change in Time in Range (TIR) — Baseline and 3 months
    Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)

Trial sites (22)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting
Hôtel Dieu-Pédiatrie Angers France Recruiting
CH Victor Dupouy Argenteuil France Recruiting
Hôpital Bois Guillaume Bois-Guillaume France Recruiting
CHU de Bordeaux Bordeaux France Recruiting
CHU Brest - Hôpital La Cavale Blanche Brest France Recruiting
Hôpital Femme Mère Enfant Lyon Bron France Recruiting
CHU Grenoble Alpes Grenoble France Recruiting
Groupe Hospitalier de la Rochelle Ré Aunis La Rochelle France Recruiting
Hospices Civils de Lyon DIAB-Ecare Lyon France Recruiting
Hôpital Européen Marseille France Recruiting
Hôpital Europeen Georges Pompidou Paris France Recruiting
Hôpital Universitaire Necker Enfants Malades Paris France Recruiting
Groupe hospitalier Bichat Claude Bernard Paris France Recruiting
CH Périgueux Périgueux France Recruiting
CHU Poitiers Poitiers France Recruiting
Hôpital NOVO, Site Pontoise Pontoise France Recruiting
CHU Toulouse Toulouse France Recruiting
Clinique Pasteur Toulouse France Recruiting
CHRU Nancy-Hôpitaux de Brabois Adultes Vandœuvre-lès-Nancy France Recruiting
CH Bretagne Atlantique Vannes France Recruiting
Hôpital Robert Schuman-UNEOS Vantoux France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07048795 on ClinicalTrials.gov ↗ ← All trials in France