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.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Quentin Perrier, PharmD, phD
- Telefonní číslo: +33 4 76 76 55 16
- E-mail: qperrier@chu-grenoble.fr
Studijní místa
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Grenoble, Francie
- Nábor
- Chu Grenoble Alpes
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Kontakt:
- Quentin Perrier, PharmD, phD
- Telefonní číslo: +33 4 76 76 55 16
- E-mail: qperrier@chu-grenoble.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Satisfaction score
Časové okno: Baseline
|
Part C, D and E of the questionnar
|
Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Describe the perception of physical activity within the study population
Časové okno: Baseline
|
Part A of the questionnar
|
Baseline
|
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Describe the proportion of individuals using the physical activity mode in our study
Časové okno: 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
Časové okno: Baseline
|
Part F of the questionnar
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Baseline
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Describe overall satisfaction with the "physical activity" mode
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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: - Mean glucose (mg/dL) |
Baseline
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Compare populations who use the physical activity mode with those who do not use it
Časové okno: 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
Časové okno: 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
Časové okno: 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: - Glycemia Risk Index (GRI) |
Baseline
|
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Compare populations who use the physical activity mode with those who do not use it
Časové okno: 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
|
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Compare populations who use the physical activity mode with those who do not use it
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 38RC26.0046
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