Diabetes type1NCT06460558
T1D Closed-loop and Physical Activity
An observational study of Diabetes type1, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control [1] but also on reducing the incidence of diabetes-related complications [2,3]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes type1
- What is being tested?
- Type 1 diabetes with insulin infusion system
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2024to 6 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Selection visit - Patients with T1DM referred to Nice University Hospital are offered the opportunity to take part in the study without obligation (D0).
Who may be able to join
- Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems.
- For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period.
- Having a Health Care insurance."" "
Who cannot join
- Patient already involved in another experimental study
- Patient in a particular situation deemed incompatible with the study by the investigator
- Patient living in a department other than Alpes-Maritimes or Var
- Pregnant women
- Presence of a contraindication to physical activity
- Patient with linguistic or psychological incapacity to understand written information
- Patient refusing to give consent
- Patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU NiICE
Nice, Alpes Maritimes, 0600
Nicolas CHEVALIER, MD, 0492035519 ext. +33, chevalier.n@chu-nice.fr
Enzo PINI, 0492035519 ext. +33, pini.e2@chu-nice.fr
About this study
Official title: "Impact of an Automated Closed-loop Insulin Infusion System on Adherence to Physical Activity in Patients With Type 1 Diabetes "
"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control [1] but also on reducing the incidence of diabetes-related complications [2,3]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity [4]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates [5]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) [6]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies [7-9]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ [10], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).
- Conditions
- Diabetes type1
- Being tested
- Type 1 diabetes with insulin infusion system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 1 diabetes with insulin infusion systemOther
Also called No intervention
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes with insulin infusion system | Not described Receives: Other: Type 1 diabetes with insulin infusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPAQ score
"Measurement of IPAQ in METs/min/week (reflects the amount of physical activity practised using a validated questionnaire). There are seven items whose the result corresponds to the sum of the given figures. "
Measured: At the inclusion
Secondary outcomes (3)
BAPAD-1 score "
The BAPAD-1 score, validated in French, will be used to assess the usual obstacles to physical activity in T1DM. It is a Likert scale (between 0-7) composed by twelve items. Then, a mean is calculated with all the answers.
Measured: At the inclusion
BREQ-2
"To assess motivation to engage in physical activity, use the BREQ-2 score, validated by ONAPS. It is a Likert scale (between 0-7) composed by six items. Then, a mean is calculated with all the answers.
Measured: At the inclusion
ONAPS PAQ
To assess sedentary behaviour, use the ONAPS PAQ score with only the sedentary behaviour section. 4 items. Then the sum of the results is calculated
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start6 May 2024
- Primary completion6 Nov 2025 (estimated)
- Study completion6 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas CHEVALIER, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460558
- Sponsor's protocol ID
- 24Endocrino01
- Status last verified
- May 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of an Automated Closed-loop Insulin Infusion System on Adherence to Physical Activity in Patients With Type 1 Diabetes "
- ClinicalTrials.gov ID
- NCT06460558
- Acronym / sponsor ID
- 24Endocrino01
- Conditions
- Diabetes type1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 6 Nov 2025 (estimated)
- Study completion
- 6 May 2026 (estimated)
- First posted
- 14 Jun 2024 (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.
"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control [1] but also on reducing the incidence of diabetes-related complications [2,3]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity [4]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates [5]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) [6]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies [7-9]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ [10], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes with insulin infusion system | – | Other: Type 1 diabetes with insulin infusion system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Selection visit - Patients with T1DM referred to Nice University Hospital are offered the opportunity to take part in the study without obligation (D0).
Key inclusion criteria (3 listed)
- Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems.
- For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period.
- Having a Health Care insurance."" "
Key exclusion criteria (8 listed)
- Patient already involved in another experimental study
- Patient in a particular situation deemed incompatible with the study by the investigator
- Patient living in a department other than Alpes-Maritimes or Var
- Pregnant women
- Presence of a contraindication to physical activity
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 |
|---|---|---|
| Type 1 diabetes with insulin infusion systemAlso: No interventionNo intervention | Other | Type 1 diabetes with insulin infusion system |
Primary outcome
IPAQ score
Time frame: At the inclusion
"Measurement of IPAQ in METs/min/week (reflects the amount of physical activity practised using a validated questionnaire). There are seven items whose the result corresponds to the sum of the given figures. "
3 secondary outcomes
BAPAD-1 score "
Time frame: At the inclusion
BREQ-2
Time frame: At the inclusion
ONAPS PAQ
Time frame: At the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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. This study is not recruiting at the moment.
Nicolas CHEVALIER principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes type1, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas CHEVALIER, MD (0492035519 ext. +33, chevalier.n@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPAQ score (time frame: At the inclusion). 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 14 Jun 2024.