Diabetes, Type 2ACTIDIABNCT06598865
Comparative Effectiveness of Prescribed Adapted Physical Activity (APA), Either Practiced Independently After Training, or Supervised by an APA Teacher, on Glycemic Regulation in People With Unbalanced Type 2 Diabetes.
A study testing adapted physical activity in people with Diabetes, Type 2 and Non-Insulin Dependent, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
Trial summary
Comparative effectiveness on glycemic balance of a non-pharmacological treatment, Adapted Physical Activity (APA), either supervised by a qualified APA instructor or unsupervised in autonomy, in individuals with inadequately controlled Type 2 Diabetes, under diet alone or non-insulin treatment. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Diabetes, Type 2, Non-Insulin Dependent, Poorly Controlled Diabetes Mellitus
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2025to Jun 2028
- Phase
- Interventional
- 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has given consent to participate in the study and has signed an informed consent form.
- Patient aged 18 to 67 years
- Patient diagnosed with type 2 diabetes
- Patient newly diagnosed or on non-insulin treatment (metformin +/- DPP4 inhibitor, GLP1 analogue +/- SGLT2 inhibitor) for whom it is considered to initiate or intensify antidiabetic treatment by introducing a new therapeutic class.
- Patient insufficiently controlled (\> 1.30 g/L fasting blood glucose measured in the laboratory twice a few days apart in a city laboratory)
- Patient with good venous access.
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- Patient capable of engaging in regular physical activity
- Patient who has undergone a coronary artery disease screening test in the year prior to inclusion according to the new recommendations of an expert consensus.
- Patient agrees to wear a FitBit Charge 6 bracelet for the entire duration of the study, including the run-in period, and agrees to recharge it and transmit the data.
Who cannot join
- Patient diagnosed with type 1 diabetes
- Patient treated with sulfonylureas
- Patient with a history of severe cardiovascular diseases (myocardial infarction, acute coronary syndrome, or stroke in the past year)
- Patient presenting a medical contraindication to performing a physical activity session (uncontrolled resting hypertension, i.e., systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg, unstable coronary artery disease, heart failure, severe proliferative or non-proliferative evolving retinopathy (unstabilized), or having undergone recent surgical laser treatment of the eye, plantar perforating ulcer, disabling osteoarthritis of the lower limbs, respiratory failure, severe renal impairment, liver failure, severe dysautonomia, i.e., risk of chronotropic insufficiency during exercise, peripheral neuropathy)
- Patient with a history of severe hypoglycemia in the 6 months prior to entering the study and/or not feeling their hypoglycemia at all
- Patient with an IPAQ score in the high category
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- Patient with a known latex allergy
- Patient with morbid obesity (BMI \> 40 kg/m²)
- Other conditions that may interfere with glycemic variation: particularly the use of corticosteroids during the study
- Patient treated with beta-blockers or calcium channel blockers with negative chronotropic action (such as isoptin)
- Breastfeeding woman
- Pregnant woman* or wishing to become pregnant
Trial locations and contacts
1 site in 1 country.
France1 site
CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète),
Évry, 91058
About this study
Official title: Comparative Effectiveness on Glycemic Balance of a Non-pharmacological Treatment, Adapted Physical Activity (APA), Either Supervised by a Qualified APA Instructor or Unsupervised in Autonomy, in Individuals With Inadequately Controlled Type 2 Diabetes, Under Diet Alone or Non-insulin Treatment.
Comparative effectiveness on glycemic balance of a non-pharmacological treatment, Adapted Physical Activity (APA), either supervised by a qualified APA instructor or unsupervised in autonomy, in individuals with inadequately controlled Type 2 Diabetes, under diet alone or non-insulin treatment.
- Being tested
- adapted physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityOther
After the initial training in adapted physical activity (APA), patients will receive regular support from an APA instructor, and they will be asked to participate in 3 sessions per week of APA, if possible in a Sport-Health center close to their home, for the entire duration of the study. The content of the additional APA sessions (up to 2 additional sessions per week) can be discussed with the APA instructor. They will also be asked to return to the study center for a visit at 3 months (Visit 3) to assess the effect of the APA conducted during this period
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | after initial APA training, patients will be asked to implement APA sessions on their own for the duration of the study. They will then be asked to return to the investigating center for a visit at 3 months (Visit 3) to assess the effect of the APA carried out during this period. |
| experimental | Experimental | after initial APA training, patients will receive regular support from an APA teacher, and will be asked to carry out 3 APA sessions a week, if possible in a Sport-Santé centre close to their home, for the duration of the study. The content of additional APA sessions (up to 2 additional sessions per week) can be discussed with the APA teacher.
They will also be asked to return to the investigating center for a visit at 3 months (Visit 3) to assess the effect of the APA carried out during this period. Receives: Other: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of a 3-month re-training program, by comparing glycemic averages (measured for 10 consecutive days at 3 months, by a continuous glucose monitoring device (CGM) between experimental group (APA) vs control group.
Measurement of glucose by CGM
Measured: 10 days after 3-month re-training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Why it stopped: The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598865
- Sponsor's protocol ID
- 2024-A01320-47
- Acronym
- ACTIDIAB
- Status last verified
- May 2026
- First submitted
- 12 Sep 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness on Glycemic Balance of a Non-pharmacological Treatment, Adapted Physical Activity (APA), Either Supervised by a Qualified APA Instructor or Unsupervised in Autonomy, in Individuals With Inadequately Controlled Type 2 Diabetes, Under Diet Alone or Non-insulin Treatment.
- ClinicalTrials.gov ID
- NCT06598865
- Acronym / sponsor ID
- ACTIDIAB / 2024-A01320-47
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Sep 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.
Comparative effectiveness on glycemic balance of a non-pharmacological treatment, Adapted Physical Activity (APA), either supervised by a qualified APA instructor or unsupervised in autonomy, in individuals with inadequately controlled Type 2 Diabetes, under diet alone or non-insulin treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –after initial APA training, patients will be asked to implement APA sessions on their own for the duration of the study. They will then be asked to return to the investigating center for a visit at 3 months (Visit 3) to assess the effect of the APA carried out during this period. |
| experimental | Experimental | Other: adapted physical activityafter initial APA training, patients will receive regular support from an APA teacher, and will be asked to carry out 3 APA sessions a week, if possible in a Sport-Santé centre close to their home, for the duration of the study. The content of additional APA sessions (up to 2 additional sessions per week) can be discussed with the APA teacher. They will also be asked to return to the investigating center for a visit at 3 months (Visit 3) to assess the effect of the APA carried out during this period. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who has given consent to participate in the study and has signed an informed consent form.
- Patient aged 18 to 67 years
- Patient diagnosed with type 2 diabetes
- Patient newly diagnosed or on non-insulin treatment (metformin +/- DPP4 inhibitor, GLP1 analogue +/- SGLT2 inhibitor) for whom it is considered to initiate or intensify antidiabetic treatment by introducing a new therapeutic class.
- Patient insufficiently controlled (\> 1.30 g/L fasting blood glucose measured in the laboratory twice a few days apart in a city laboratory)
Key exclusion criteria (12 listed)
- Patient diagnosed with type 1 diabetes
- Patient treated with sulfonylureas
- Patient with a history of severe cardiovascular diseases (myocardial infarction, acute coronary syndrome, or stroke in the past year)
- Patient presenting a medical contraindication to performing a physical activity session (uncontrolled resting hypertension, i.e., systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg, unstable coronary artery disease, heart failure, severe proliferative or non-proliferative evolving retinopathy (unstabilized), or having undergone recent surgical laser treatment of the eye, plantar perforating ulcer, disabling osteoarthritis of the lower limbs, respiratory failure, severe renal impairment, liver failure, severe dysautonomia, i.e., risk of chronotropic insufficiency during exercise, peripheral neuropathy)
- Patient with a history of severe hypoglycemia in the 6 months prior to entering the study and/or not feeling their hypoglycemia at all
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 |
|---|---|---|
| adapted physical activityAfter the initial training in adapted physical activity (APA), patients will receive regular support from an APA instructor, and they will be asked to participate in 3 sessions per week of APA, if possible in a Sport-Health center close to their home, for the entire duration of the study. The content of the additional APA sessions (up to 2 additional sessions per week) can be discussed with the APA instructor. They will also be asked to return to the study center for a visit at 3 months (Visit 3) to assess the effect of the APA conducted during this period | Other | experimental |
Primary outcome
Evaluate the efficacy of a 3-month re-training program, by comparing glycemic averages (measured for 10 consecutive days at 3 months, by a continuous glucose monitoring device (CGM) between experimental group (APA) vs control group.
Time frame: 10 days after 3-month re-training program
Measurement of glucose by CGM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Diabetes, Type 2 and Non-Insulin Dependent, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète 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 9 inclusion and 12 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: paused, as of the sponsor's last update on 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of a 3-month re-training program, by comparing glycemic averages (measured for 10 consecutive days at 3 months, by a continuous glucose monitoring device (CGM) between experimental group (APA) vs control group. (time frame: 10 days after 3-month re-training program). 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 15 May 2026.