EndocrinologyFREEDIANCT05676593
Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients
A study testing Freestyle Libre 2 and Therapeutic education in people with Endocrinology and Type 2 Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes. The benefit of therapeutic education (TPE) has been clearly established on glycaemic control. Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrinology, Type 2 Diabetes
- What is being tested?
- Freestyle Libre 2 and Therapeutic education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2023to 25 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recently diagnosed diabete mellitus (<1 an) treated by non medical therapeutics and/or metformine
- > 18 years old
- initial glycated hemoglobin between 7 and 8.5%
Who cannot join
- Person whose physical and/or psychological health is severely impaired
- Person deprived of his rights, person under guardianship or curatorship
- Person deprived of liberty (by judicial or administrative decision)
- Person who does not speak the French language
- Absence of affiliation to/Not beneficiary of a Social Security scheme
- Absence of written informed consent to participate in the study
- Unable to understand the nature, purpose and methodology of the study
- Bariatric surgery planned within 6 months of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients
Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.
The benefit of therapeutic education (TPE) has been clearly established on glycaemic control.
Read more
Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.
The investigators therefore propose a prospective randomised study in 2 arms :
- a group of people living with diabetes receiving standard TPE vs
- a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms
Read the detailed description
Main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard TPE (Patient Therapeutic Education) vs standard TPE alone in newly diagnosed type 2 diabetics on HbA1c at 3 months.
The secondary objectives are to evaluate the effect of the TPE coupled with FSL vs TPE alone on :
- HbA1c at 6 months (assessment of persistence or not of a remote effect)
- weight change at 3 and 6 months
- other cardiovascular risk factors : variation in blood pressure, lipid profil at 3 and 6 months
- eating behaviour/ eating habits at 3 and 6 months
- treatment satisfaction, anxiety and quality of life scores
- Conditions
- Endocrinology, Type 2 Diabetes
- Being tested
- Freestyle Libre 2, Therapeutic education
- Keywords
- Sensor, Therapeutic education, Diabete, Glucose
- 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.
Freestyle Libre 2Device
The FSL will be placed on patient for 28 days to measure interstitial glucose
Therapeutic educationOther
Therapeutic education
| Study group | Role | What they receive |
|---|---|---|
| People living with diabete standard TPE | Active comparator | HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months Receives: Other: Therapeutic education |
| People living with diabete standard TPE + FSL 28 days | Experimental | Continuous mesure of glucose (FSL2) during 28 days at enrollment Therapeutic education HBA1c at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months
Auto questionnary on Aviitam plateform at 3 and 6 months Receives: Device: Freestyle Libre 2; Other: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in glycated hemoglobine at 3 months
biological control of glycated hemoglobin in a laboratory
Measured: 3 months
Secondary outcomes (10)
Rate of change of the time in range, time above range and time below range
data of the freestyle libre
Measured: 6 months
Rate of change in glycated hemoglobin at 6 months
biological control
Measured: 6 months
Rate of change in weight in kg
Measured: In kg each 3,6 months
Quality of Life questionnary
EQVOD - Scale of Quality of Life, Obesity and Dietetics
Measured: Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months
Rate of change arteriel pressure
Measured: In mmHg each 3,6 months
Concentration of of LDL cholesterol
Measured: In g/L each 3,6 months
Concentration of Triglyceride
Measured: In g/L each 3,6 months
Anxiety and depression scale questionnary
HAD - Hospital Anxiety and Depression scale
Measured: 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months
Quality of Life questionnary
EQ-5D - EuroQoL-5D
Measured: From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months
Eating behavior questionnaire
DEBQ-Dutch Eating Behaviour Questionnaire
Measured: 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start3 May 2023
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Why it stopped: Abbott has discontinued marketing of the medical device under investigation. FREESTYLE LIBRE 2 has been replaced by FREESTYLE LIBRE 2+, whose characteristics have been slightly modified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocrinologyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We therefore propose a prospective randomised study in 2 arms : * a group of people living with diabetes receiving standard TPE vs * a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676593
- Sponsor's protocol ID
- RECHMPL22_0232
- Other IDs
- 2022-A01899-34
- Acronym
- FREEDIA
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients
- ClinicalTrials.gov ID
- NCT05676593
- Acronym / sponsor ID
- FREEDIA / RECHMPL22_0232
- Conditions
- Endocrinology, Type 2 Diabetes
- Keywords
- Sensor, Therapeutic education, Diabete, Glucose
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Abbott has discontinued marketing of the medical device under investigation. FREESTYLE LIBRE 2 has been replaced by FREESTYLE LIBRE 2+, whose characteristics have been slightly modified.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 9 Jan 2023 (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.
Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.
The benefit of therapeutic education (TPE) has been clearly established on glycaemic control.
Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.
The investigators therefore propose a prospective randomised study in 2 arms :
- a group of people living with diabetes receiving standard TPE vs
- a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms
Detailed description
Main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard TPE (Patient Therapeutic Education) vs standard TPE alone in newly diagnosed type 2 diabetics on HbA1c at 3 months.
The secondary objectives are to evaluate the effect of the TPE coupled with FSL vs TPE alone on :
- HbA1c at 6 months (assessment of persistence or not of a remote effect)
- weight change at 3 and 6 months
- other cardiovascular risk factors : variation in blood pressure, lipid profil at 3 and 6 months
- eating behaviour/ eating habits at 3 and 6 months
- treatment satisfaction, anxiety and quality of life scores
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We therefore propose a prospective randomised study in 2 arms : * a group of people living with diabetes receiving standard TPE vs * a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms
| Arm | Type | Receives |
|---|---|---|
| People living with diabete standard TPE | Active comparator | Other: Therapeutic educationHBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months |
| People living with diabete standard TPE + FSL 28 days | Experimental | Device: Freestyle Libre 2, Other: Therapeutic educationContinuous mesure of glucose (FSL2) during 28 days at enrollment Therapeutic education HBA1c at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- recently diagnosed diabete mellitus (<1 an) treated by non medical therapeutics and/or metformine
- > 18 years old
- initial glycated hemoglobin between 7 and 8.5%
Key exclusion criteria (8 listed)
- Person whose physical and/or psychological health is severely impaired
- Person deprived of his rights, person under guardianship or curatorship
- Person deprived of liberty (by judicial or administrative decision)
- Person who does not speak the French language
- Absence of affiliation to/Not beneficiary of a Social Security scheme
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 |
|---|---|---|
| Freestyle Libre 2The FSL will be placed on patient for 28 days to measure interstitial glucose | Device | People living with diabete standard TPE + FSL 28 days |
| Therapeutic educationTherapeutic education | Other | People living with diabete standard TPE, People living with diabete standard TPE + FSL 28 days |
Primary outcome
Rate of change in glycated hemoglobine at 3 months
Time frame: 3 months
biological control of glycated hemoglobin in a laboratory
10 secondary outcomes
Rate of change of the time in range, time above range and time below range
Time frame: 6 months
Rate of change in glycated hemoglobin at 6 months
Time frame: 6 months
Rate of change in weight in kg
Time frame: In kg each 3,6 months
Quality of Life questionnary
Time frame: Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months
Rate of change arteriel pressure
Time frame: In mmHg each 3,6 months
Concentration of of LDL cholesterol
Time frame: In g/L each 3,6 months
Concentration of Triglyceride
Time frame: In g/L each 3,6 months
Anxiety and depression scale questionnary
Time frame: 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months
Quality of Life questionnary
Time frame: From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months
Eating behavior questionnaire
Time frame: 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months
Results and safety
The study was stopped early (reason given: Abbott has discontinued marketing of the medical device under investigation. FREESTYLE LIBRE 2 has been replaced by FREESTYLE LIBRE 2+, whose characteristics have been slightly modified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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 Freestyle Libre 2 and Therapeutic education in people with Endocrinology and Type 2 Diabetes, run by University Hospital, Montpellier 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: stopped early, as of the sponsor's last update on 15 Jun 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?
The study was stopped early (reason given: Abbott has discontinued marketing of the medical device under investigation. FREESTYLE LIBRE 2 has been replaced by FREESTYLE LIBRE 2+, whose characteristics have been slightly modified.). 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?
Rate of change in glycated hemoglobine at 3 months (time frame: 3 months). 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 Jun 2026.