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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 23
- 主要终点
- Change in Time in Range (TIR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Participants with type 1 diabetes initiating the hybrid closed-loop system
Participants (adults and minors) with type 1 diabetes (T1D) initiating the mylife CamAPS FX system combined with the Dexcom G6 sensor, under real-life management conditions
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Change in Time in Range (TIR)
时间窗: Baseline and 3 months
Change in Time in Range (TIR, 70-180 mg/dL; for pregnant women: TIR, 63-140 mg/dL) (%)
次要结局
- Change in Coefficient of Variation (CV) of glucose from inclusion to 3 months, and to 12 months(Inclusion, 3 months and 12 months)
- Change in the PAID questionnaire score from inclusion to 3 months, and to 12 months(Inclusion, 3 months and 12 months)
- Change in Time Below Range (TBR) from inclusion to 3 months and 12 months(Inclusion, 3 and 12 months)
- Change in average glucose levels from CGM sensor data from inclusion to 3 months, and to 12 months(Inclusion, 3 months and 12 months)
- Change in Standard Deviation (SD) of glucose from inclusion to 3 months, and to 12 months(Inclusion, 3 months and 12 months)
- Change in the DTSQ questionnaire score from inclusion to 3 months, and to12 months(Inclusion, 3 months and 12 months)
- Change in the HFS-II questionnaire score from inclusion to 3 months, and to 12 months(Inclusion, 3 months and 12 months)
- Perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia, and sleep quality at 3 months, and at 12 months(Inclusion, at 3 months and 12 months)
- System usage modalities(3 months and 12 months)
- Time in hybrid closed-loop(3 months and 12 months)
- Safety / Adverse events related to the use of the System(3 months and 12 months)
- Change in Standard Deviation (SD) of glucose(Baseline, 3 months and 12 months)
- Change in Time in Range (TIR)(Baseline and 12 months)
- Change in Time In Tight Range (TITR)(Baseline, 3 and 12 months)
- Change in Time Above Range (TAR)(Baseline, 3 months, and 12 months)
- Change in Time Below Range (TBR)(Baseline, 3 and 12 months)
- Change in average glucose levels from CGM sensor data(Baseline, 3 months and 12 months)
- Change in Coefficient of Variation (CV) of glucose(Baseline, 3 months and 12 months)
- Change in Glucose Management Indicator (GMI)(Baseline, 3 months and 12 months)
- Change in HbA1c(Baseline, 3 months and 12 months)
- Change in the PAID questionnaire score(Baseline, 3 months and 12 months)
- Change in the DTSQ questionnaire score(Baseline, 3 months and 12 months)
- Change in the HFS-II questionnaire score(Baseline, 3 months and 12 months)
- Change in the PSQI questionnaire score(Baseline, 3 months and 12 months)
- Perceived changes in quality of life, treatment satisfaction, fear of hypoglycemia, and sleep quality(Baseline, at 3 months and 12 months)