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

Recruitingn/aAges any - anyAllmylife Diabetes Care AG
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In plain words

What the trial is, and whether it could suit you

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 a

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • No Intervention: Observational Cohort
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Where

22 sites
CHU Amiens
Amiens, France
Hôtel Dieu-Pédiatrie
Angers, France
CH Victor Dupouy
Argenteuil, France
Hôpital Bois Guillaume
Bois-Guillaume, France
CHU de Bordeaux
Bordeaux, France
CHU Brest - Hôpital La Cavale Blanche
Brest, France
Hôpital Femme Mère Enfant Lyon
Bron, France
CHU Grenoble Alpes
Grenoble, France

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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