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Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System (BF-ACT)

27 april 2026 bijgewerkt door: University Hospital, Grenoble

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

900

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Only 1 arm = patient treated with AID systems
Ander: Questionnar
Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Satisfaction score
Tijdsspanne: Baseline
Part C, D and E of the questionnar
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Describe the perception of physical activity within the study population
Tijdsspanne: Baseline
Part A of the questionnar
Baseline
Describe the proportion of individuals using the physical activity mode in our study
Tijdsspanne: Baseline
Part B of the questionnar
Baseline
Describe satisfaction with the mode in relation to the physical activities performed by patients
Tijdsspanne: Baseline
Part F of the questionnar
Baseline
Describe overall satisfaction with the "physical activity" mode
Tijdsspanne: Baseline
Part G of the questionnar
Baseline
Compare populations who use the physical activity mode with those who do not use it
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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:

  • Time in Range (TIR) 70-180 mg/dL
  • Time in Tight Range (TITR) 70-140 mg/dL
  • Time Above Range (TAR) > 180 mg/dL and > 250 mg/dL
  • Time Below Range (TBR) < 70 mg/dL and < 54 mg/dL
Baseline
Compare populations who use the physical activity mode with those who do not use it
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Grenoble

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 april 2026

Primaire voltooiing (Geschat)

31 augustus 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

20 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 38RC26.0046

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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