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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 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

900

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Frankrike
      • Grenoble, Frankrike
        • Rekrytering
        • CHU Grenoble Alpes
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Only 1 arm = patient treated with AID systems
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Satisfaction score
Tidsram: Baseline
Part C, D and E of the questionnar
Baseline

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Grenoble

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 april 2026

Primärt slutförande (Beräknad)

31 augusti 2026

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

20 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 38RC26.0046

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