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.
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Quentin Perrier, PharmD, phD
- Número de telefone: +33 4 76 76 55 16
- E-mail: qperrier@chu-grenoble.fr
Locais de estudo
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Grenoble, França
- Recrutamento
- CHU Grenoble Alpes
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Contato:
- Quentin Perrier, PharmD, phD
- Número de telefone: +33 4 76 76 55 16
- E-mail: qperrier@chu-grenoble.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Satisfaction score
Prazo: Baseline
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Part C, D and E of the questionnar
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Baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Describe the perception of physical activity within the study population
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 38RC26.0046
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