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

Официальное название

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

Обзор

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.

Подробное описание

This study, called EPICAM-PMCF-G6, is part of a Post-Market Clinical Follow-up (PMCF) requested by the French Health Technology Assessment Committee (CNEDiMTS), following the listing of the System for reimbursement under the national healthcare system in France.

Вмешательства

• Другое No Intervention: Observational Cohort
  No intervention

Первичные конечные точки

• Change in Time in Range (TIR) [Срок оценки: Baseline and 3 months]

Вторичные конечные точки (12)

• Change in Time in Range (TIR) [Срок оценки: Baseline and 12 months]
• Change in Time In Tight Range (TITR) [Срок оценки: Baseline, 3 and 12 months]
• Change in Time Above Range (TAR) [Срок оценки: Baseline, 3 months, and 12 months]
• Change in Time Below Range (TBR) [Срок оценки: Baseline, 3 and 12 months]
• Change in average glucose levels from CGM sensor data [Срок оценки: Baseline, 3 months and 12 months]
• Change in Standard Deviation (SD) of glucose [Срок оценки: Baseline, 3 months and 12 months]
• Change in Coefficient of Variation (CV) of glucose [Срок оценки: Baseline, 3 months and 12 months]
• Change in Glucose Management Indicator (GMI) [Срок оценки: Baseline, 3 months and 12 months]
• Change in HbA1c [Срок оценки: Baseline, 3 months and 12 months]
• Time in hybrid closed-loop [Срок оценки: 3 months and 12 months]
• System usage modalities [Срок оценки: 3 months and 12 months]
• Change in the PAID questionnaire score [Срок оценки: Baseline, 3 months and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 22 центра

• CHU Amiens — Amiens
• Hôtel Dieu-Pédiatrie — Angers
• CH Victor Dupouy — Argenteuil
• Hôpital Bois Guillaume — Bois-Guillaume
• CHU de Bordeaux — Bordeaux
• CHU Brest - Hôpital La Cavale Blanche — Brest
• Hôpital Femme Mère Enfant Lyon — Bron
• CHU Grenoble Alpes — Grenoble
• … и ещё 14 центров

Идентификаторы

NCT: NCT07048795 · 2024-A00207-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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