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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Quentin Perrier, PharmD, phD
- Puhelinnumero: +33 4 76 76 55 16
- Sähköposti: qperrier@chu-grenoble.fr
Opiskelupaikat
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-
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Grenoble, Ranska
- Rekrytointi
- CHU Grenoble Alpes
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Ottaa yhteyttä:
- Quentin Perrier, PharmD, phD
- Puhelinnumero: +33 4 76 76 55 16
- Sähköposti: qperrier@chu-grenoble.fr
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Muut: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Satisfaction score
Aikaikkuna: Baseline
|
Part C, D and E of the questionnar
|
Baseline
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Describe the perception of physical activity within the study population
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 38RC26.0046
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