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
- Diseases
- Type 1 diabetes
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Hôtel Dieu-Pédiatrie Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| CH Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil | France | Recruiting |
| Hôpital Bois Guillaume Coordinator of this site? Confirm its status | Bois-Guillaume | France | Recruiting |
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Brest, Hopital La Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hôpital Femme Mère Enfant Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Groupe Hospitalier de la Rochelle Re-Aunis Coordinator of this site? Confirm its status | La Rochelle | France | Recruiting |
| Hospices Civils de Lyon DIAB-Ecare Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hopital Europeen Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Groupe Hospitalier Bichat Claude Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Universitaire Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CH Périgueux Coordinator of this site? Confirm its status | Périgueux | France | Recruiting |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Hôpital NOVO, Site Pontoise Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
| CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHRU Nancy-Hôpitaux de Brabois Adultes Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| CH Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Recruiting |
| Hôpital Robert Schuman-UNEOS Coordinator of this site? Confirm its status | Vantoux | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.