DiabetesBF-ACTNCT07567170
Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System
A study testing Questionnar in people with Diabetes, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Questionnar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People opposed to the research
- People protected by the law
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble
Quentin Perrier, PharmD, phD, +33 4 76 76 55 16, qperrier@chu-grenoble.fr
About this study
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.
Read more
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.
- Conditions
- Diabetes
- Being tested
- Questionnar
- Keywords
- Closed-loop, automated insulin delivery, physical activity, PROMs
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnarOther
Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Only 1 arm = patient treated with AID systems | Other | Not described Receives: Other: Questionnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction score
Part C, D and E of the questionnar
Measured: Baseline
Secondary outcomes (19)
Describe the perception of physical activity within the study population
Part A of the questionnar
Measured: Baseline
Describe the proportion of individuals using the physical activity mode in our study
Part B of the questionnar
Measured: Baseline
Describe satisfaction with the mode in relation to the physical activities performed by patients
Part F of the questionnar
Measured: Baseline
Describe overall satisfaction with the "physical activity" mode
Part G of the questionnar
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
HbA1c (%)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Type of closed-loop system
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Duration of use of the closed-loop system
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Time spent in closed-loop mode
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Duration of type 1 diabetes
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Age
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Sex
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion:
Body Mass Index (BMI)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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 %)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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)
Measured: Baseline
Compare populations who use the physical activity mode with those who do not use it
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start21 Apr 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567170
- Sponsor's protocol ID
- 38RC26.0046
- Acronym
- BF-ACT
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System
- ClinicalTrials.gov ID
- NCT07567170
- Acronym / sponsor ID
- BF-ACT / 38RC26.0046
- Conditions
- Diabetes
- Keywords
- Closed-loop, automated insulin delivery, physical activity, PROMs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only 1 arm = patient treated with AID systems | Other | Other: Questionnar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- People opposed to the research
- People protected by the law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnarAdministration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes. | Other | Only 1 arm = patient treated with AID systems |
Primary outcome
Satisfaction score
Time frame: Baseline
Part C, D and E of the questionnar
19 secondary outcomes
Describe the perception of physical activity within the study population
Time frame: Baseline
Describe the proportion of individuals using the physical activity mode in our study
Time frame: Baseline
Describe satisfaction with the mode in relation to the physical activities performed by patients
Time frame: Baseline
Describe overall satisfaction with the "physical activity" mode
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnar in people with Diabetes, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin Perrier, PharmD, phD (+33 4 76 76 55 16, qperrier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.