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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Quentin Perrier, PharmD, phD
- 電話番号：+33 4 76 76 55 16
- メール：qperrier@chu-grenoble.fr
研究場所
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Grenoble、フランス
- 募集
- CHU Grenoble Alpes
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コンタクト：
- Quentin Perrier, PharmD, phD
- 電話番号：+33 4 76 76 55 16
- メール：qperrier@chu-grenoble.fr
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Satisfaction score
時間枠：Baseline
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Part C, D and E of the questionnar
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Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Describe the perception of physical activity within the study population
時間枠：Baseline
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Part A of the questionnar
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Baseline
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Describe the proportion of individuals using the physical activity mode in our study
時間枠：Baseline
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Part B of the questionnar
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Baseline
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Describe satisfaction with the mode in relation to the physical activities performed by patients
時間枠：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
時間枠：Baseline
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Part G of the questionnar
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Baseline
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Compare populations who use the physical activity mode with those who do not use it
時間枠：Baseline
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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:
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Baseline
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Compare populations who use the physical activity mode with those who do not use it
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Compare populations who use the physical activity mode with those who do not use it
時間枠：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: - Total daily insulin dose (IU/day) |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
時間枠：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: - Percentage of use of the physical activity mode |
Baseline
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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