Clinical trial NCT05676593: Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients
Official title: Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endocrinology
Type 2 Diabetes
Keywords: Sensor
Therapeutic education
Diabete
Glucose
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of change in glycated hemoglobine at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Rate of change of the time in range, time above range and time below range
timeFrame: 6 months
measure: Rate of change in glycated hemoglobin at 6 months
timeFrame: 6 months
measure: Rate of change in weight in kg
timeFrame: In kg each 3,6 months
measure: Quality of Life questionnary
timeFrame: Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months
measure: Rate of change arteriel pressure
timeFrame: In mmHg each 3,6 months
measure: Concentration of of LDL cholesterol
timeFrame: In g/L each 3,6 months
measure: Concentration of Triglyceride
timeFrame: In g/L each 3,6 months
measure: Anxiety and depression scale questionnary
timeFrame: 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months
measure: Quality of Life questionnary
timeFrame: From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months
measure: Eating behavior questionnaire
timeFrame: 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UHM Montpellier
Study officials:
References: