Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System (BF-ACT)
The BF-ACT study is a single-center, non-interventional (RIPH3) descriptive study conducted at CHU Grenoble Alpes. It aims to evaluate the satisfaction of adults with type 1 diabetes using closed-loop insulin delivery systems, specifically regarding the "physical activity mode" designed to adapt insulin delivery during exercise.
Although physical activity is essential for managing type 1 diabetes, it remains challenging due to the risk of hypoglycemia. Closed-loop systems have improved glucose control, but their effectiveness during exercise depends on multiple factors, and their real-life use can be complex. Currently, little is known about patient satisfaction and experience with these specific modes.
The study will collect data through a self-administered questionnaire, distributed to eligible patients (≥18 years old, with type 1 diabetes, using a closed-loop system for at least 4 months). The primary outcome is the satisfaction score based on the questionnaire. Secondary objectives include describing physical activity perception, usage of the activity mode, and comparing users versus non-users.
Approximately up to 900 patients may be included over a 4-month recruitment period. Clinical and glucose monitoring data will also be collected from medical records. The results are expected to improve patient education, device usability, and support for physical activity in people living with type 1 diabetes.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Quentin Perrier, PharmD, phD
- 电话号码：+33 4 76 76 55 16
- 邮箱：qperrier@chu-grenoble.fr
学习地点
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-
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Grenoble、法国
- 招聘中
- CHU Grenoble Alpes
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接触：
- Quentin Perrier, PharmD, phD
- 电话号码：+33 4 76 76 55 16
- 邮箱：qperrier@chu-grenoble.fr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria
- Age ≥ 18 years
- Patient living with type 1 diabetes
- Patient using a closed-loop system for at least 4 months
- Patient followed by a diabetologist in our center
Exclusion criteria
- People opposed to the research
- People protected by the law
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Only 1 arm = patient treated with AID systems
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Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction score
大体时间：Baseline
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Part C, D and E of the questionnar
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Describe the perception of physical activity within the study population
大体时间：Baseline
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Part A of the questionnar
|
Baseline
|
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Describe the proportion of individuals using the physical activity mode in our study
大体时间：Baseline
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Part B of the questionnar
|
Baseline
|
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Describe satisfaction with the mode in relation to the physical activities performed by patients
大体时间：Baseline
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Part F of the questionnar
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Baseline
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Describe overall satisfaction with the "physical activity" mode
大体时间：Baseline
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Part G of the questionnar
|
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: HbA1c (%) |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Type of closed-loop system |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Duration of use of the closed-loop system |
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Time spent in closed-loop mode |
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Duration of type 1 diabetes |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Age |
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Sex |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Body Mass Index (BMI) |
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion:
|
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: - Mean glucose (mg/dL) |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: - Glucose Management Index (GMI) |
Baseline
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: - Coefficient of Variation (CV, in %) |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
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Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: - Glycemia Risk Index (GRI) |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: - Total daily insulin dose (IU/day) |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
大体时间：Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: - Percentage of use of the physical activity mode |
Baseline
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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