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.
Studieoversigt
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Quentin Perrier, PharmD, phD
- Telefonnummer: +33 4 76 76 55 16
- E-mail: qperrier@chu-grenoble.fr
Studiesteder
-
-
-
Grenoble, Frankrig
- Rekruttering
- Chu Grenoble Alpes
-
Kontakt:
- Quentin Perrier, PharmD, phD
- Telefonnummer: +33 4 76 76 55 16
- E-mail: qperrier@chu-grenoble.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Only 1 arm = patient treated with AID systems
|
Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction score
Tidsramme: Baseline
|
Part C, D and E of the questionnar
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Describe the perception of physical activity within the study population
Tidsramme: Baseline
|
Part A of the questionnar
|
Baseline
|
|
Describe the proportion of individuals using the physical activity mode in our study
Tidsramme: Baseline
|
Part B of the questionnar
|
Baseline
|
|
Describe satisfaction with the mode in relation to the physical activities performed by patients
Tidsramme: Baseline
|
Part F of the questionnar
|
Baseline
|
|
Describe overall satisfaction with the "physical activity" mode
Tidsramme: Baseline
|
Part G of the questionnar
|
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: HbA1c (%) |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Type of closed-loop system |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
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
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Time spent in closed-loop mode |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Duration of type 1 diabetes |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Age |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Sex |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: Baseline
|
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Body Mass Index (BMI) |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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:
|
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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: - Glucose Management Index (GMI) |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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: - Coefficient of Variation (CV, in %) |
Baseline
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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
|
|
Compare populations who use the physical activity mode with those who do not use it
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 38RC26.0046
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .