Glycemic Control and Quality of Life Evolution for Patients With T1D Using the myLoop Powered by CamAPS FX System in Combination With FreeStyle Libre 3 / 3 Plus Sensors in France
2026年9月28日 更新者：mylife Diabetes Care AG
Evolution in Glycemic Control and Quality of Life in Patients With Type 1 Diabetes Using the myLoop System With FreeStyle Libre 3 / 3 Plus Sensors in a Real-World Setting in France
The goal of this observational study is to learn how glucose control changes over one year in people with type 1 diabetes who use the myLoop with CamAPS FX and Freestyle Libre 3 or FreeStyle Libre 3 Plus during usual care in France. The main question it aims to answer is:
• How time in range (TIR) changes after one year of use. Time in range is the percentage of time glucose levels stay within the target range.
As secondary aims, the study aims to answer how other glucose measures (other than TIR, for example Time Above / Below Range) change at six months and one year.
Participants who are prescribed the myLoop with CamAPS FX during usual care for Type 1 Diabetes will:
- agree to have their routine clinical data on diabetes management and related complications before and after starting therapy with myLoop with CamAPS FX used for this study.
- answer online survey questions about their quality of life, use of the device and features and treatment satisfaction at six months and one year.
研究概览
研究类型
观察性的
注册 (估计的)
220
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study population will be recruited in France from 20 public or private hospitals and clinics which are qualified as insulin pump initiating centers according to national health reimbursement criteria.
描述
Inclusion Criteria:
- Patient has Type 1 Diabetes.
- Patient is 2 years or older if using FreeStyle Libre 3 Plus.
- Patient is 4 years or older if using FreeStyle Libre 3.
- Patient and their diabetes doctor have decided that the patient will use the myLoop with CamAPS FX and the FreeStyle Libre 3 or FreeStyle Libre 3 Plus as part of their diabetes treatment.
- The patient, or their parent/legal guardian if they are under 18, has a smartphone that works with CamAPS FX.
- The patient, or their parent/legal guardian if they are under 18, has a working email address and mobile phone number.
For adult patients:
- The patient has received the study information and has signed a consent form agreeing to take part in the study and to the use of their personal data for the study.
- Patient can read and understand French.
- Patient agrees to complete the online questionnaires and is able to use a smartphone.
For patients under 18 years of age:
- The patient's parent(s) or legal guardian(s) signed a consent form agreeing for the patient to take part in the study and for the patient's personal data to be used for the study. At least one parent or legal guardian must provide consent, as applicable. The patient will also be asked, appropriate for their age and understanding, to agree to take part in the study.
- Patient and/or their parent or legal guardian, as applicable, can read and understand French.
- Patient is old enough to complete the questionnaires, or their parent or legal guardian agrees to complete the online questionnaires; the person completing the questionnaires is able to use a smartphone.
Exclusion Criteria:
- Patient is currently using, or has used in the past 6 months, any hybrid closed-loop, fully closed-loop, or homemade ("do-it-yourself") closed-loop system.
- Patient is under a legal protection measure, such as guardianship or another form of court-ordered protection.
- Patient has a medical reason why the myLoop with CamAPAS FX and FreeStyle Libre 3/3 Plus system should not be used, including any reason listed in the most recent instructions for use of any of these medical devices.
- Patient has an unresolved skin condition where the sensor and/or pump tubing would be placed, such as psoriasis, dermatitis herpetiformis, a skin rash, or a staphylococcal (staph) infection.
- Patient is expected to not be able to continue follow-up at the study center for the next 12 months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from Baseline in the percentage of time in the 70 - 180 mg/dL range (TIR) at 12 Months
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percentage of time in the 70 - 180 mg/dL range (TIR) at 6 months
大体时间：Baseline and 6 months
|
Baseline and 6 months
|
|
Percentage of time in the 70 - 140 mg/dL range (TITR) at 6 Months
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time in the 70 - 140 mg/dL range (TITR) at 12 Months
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 6 Months
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time above 250 mg/dL (TAR > 250 mg/dL) at 12 Months
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 6 Months
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time above 180 mg/dL (TAR > 180 mg/dL) at 12 Months
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 6 Months
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time below 70 mg/dL (TBR < 70 mg/dL) at 12 Months
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 6 Months
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Percentage of time below 54 mg/dL (TBR < 54 mg/dL) at 12 Months
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Mean glucose derived from CGM data (mg/dL)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Mean glucose derived from CGM data (mg/dL)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose standard deviation (SD) derived from CGM data (mg/dL)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose standard deviation (SD) derived from CGM data (mg/dL)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose coefficient of variation (CV) derived from CGM data
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose coefficient of variation (CV) derived from CGM data
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose Management Indicator (GMI) derived from CGM data
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose Management Indicator (GMI) derived from CGM data
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Glucose Risk Index (GRI) derived from CGM data
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Glucose Risk Index (GRI) derived from CGM data
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Change in HbA1c levels (%)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Change in HbA1c levels (%)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients <13: Quality of Life questionnaire (animated emoji scale)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients <13: Quality of Life questionnaire (animated emoji scale)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Problem Areas In Diabetes (PAID)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Problem Areas In Diabetes-Teen (PAID-T)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients < 13: Parent-Problem Areas In Diabetes-Children (P-PAID-C)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Diabetes Treatment Satisfaction Questionnaire (DTSQs)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Diabetes Treatment Satisfaction Questionnaire-Teen (DTSQs-T)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged < 13 years: Diabetes Treatment Satisfaction Questionnaire-Parent (DTSQs-Parent)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 13 years: Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged < 13 years: Children's Sleep Habits Questionnaire - Short-Form (SF-CSHQ)
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: INSPIRE questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: INSPIRE questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: INSPIRE Youth questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: INSPIRE Youth questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients < 13 years: INSPIRE Parent questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients < 13 years: INSPIRE Parent questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged ≥ 18 years: Hypoglycemia Fear Survey II (HFS-II) questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged 13-17 years: Hypoglycemia Fear Survey II - Child (HFS-II-C) questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients aged < 13 years: Hypoglycemia Fear Survey - Parents of Young Children II (HFS-PYC II) questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
大体时间：Baseline and 6 Months
|
Baseline and 6 Months
|
|
Patients ≥ 13 years / Parents of Patients ≥ 2 years: System Usability Scale (SUS) questionnaire
大体时间：Baseline and 12 Months
|
Baseline and 12 Months
|
|
Changes in quality of life, mental health, treatment satisfaction, diabetes burden and sleep quality: Patient Global Impression of Change (PGIC)
大体时间：at 12 Months
|
at 12 Months
|
|
Patients aged > 12 years and non-pregnant women: questionnaire on Liberty mode
大体时间：at 12 Months
|
at 12 Months
|
|
Percentage of time in hybrid closed-loop (%)
大体时间：at 6 Months
|
at 6 Months
|
|
Percentage of time in hybrid closed-loop (%)
大体时间：at 12 Months
|
at 12 Months
|
|
Percentage of time using different system features (%)
大体时间：at 6 Months
|
at 6 Months
|
|
Percentage of time using different system features (%)
大体时间：at 12 Months
|
at 12 Months
|
|
Number of Safety / Adverse Events: Severe Hypoglycemia
大体时间：At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Severe Hypoglycemia
大体时间：At 12 Months
|
At 12 Months
|
|
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
大体时间：At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Diabetic Ketoacidosis (DKA)
大体时间：At 12 Months
|
At 12 Months
|
|
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
大体时间：At 6 Months
|
At 6 Months
|
|
Number of Safety / Adverse Events: Unplanned diabetes-related hospitalizations
大体时间：At 12 Months
|
At 12 Months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2028年4月1日
研究注册日期
首次提交
2026年9月17日
首先提交符合 QC 标准的
2026年9月17日
首次发布 (实际的)
2026年9月23日
研究记录更新
最后更新发布 (实际的)
2026年10月1日
上次提交的符合 QC 标准的更新
2026年9月28日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- CIV-FR-26-08-059499
- 2026-A01226-45 (其他标识符：ANSM France)
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