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.
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Quentin Perrier, PharmD, phD
- Numero di telefono: +33 4 76 76 55 16
- Email: qperrier@chu-grenoble.fr
Luoghi di studio
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Grenoble, Francia
- Reclutamento
- Chu Grenoble Alpes
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Contatto:
- Quentin Perrier, PharmD, phD
- Numero di telefono: +33 4 76 76 55 16
- Email: qperrier@chu-grenoble.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Satisfaction score
Lasso di tempo: Baseline
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Part C, D and E of the questionnar
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Baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Describe the perception of physical activity within the study population
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 38RC26.0046
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