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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form to participate in the study or minor patient whose parents signed an willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

OTHER

No Intervention: Observational Cohort

No intervention

Locations (20)

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