Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients
- Conditions
- EndocrinologyType 2 Diabetes
- Interventions
- Device: Freestyle Libre 2Other: Therapeutic education
- Registration Number
- NCT05676593
- Lead Sponsor
- University Hospital, Montpellier
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description People living with diabete standard TPE + FSL 28 days Freestyle Libre 2 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 People living with diabete standard TPE + FSL 28 days Therapeutic education 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 People living with diabete standard TPE Therapeutic education HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months
- Primary Outcome Measures
Name Time Method Rate of change in glycated hemoglobine at 3 months 3 months biological control of glycated hemoglobin in a laboratory
- Secondary Outcome Measures
Name Time Method Concentration of of LDL cholesterol In g/L each 3,6 months Quality of Life questionnary From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months EQ-5D - EuroQoL-5D
Rate of change in glycated hemoglobin at 6 months 6 months biological control
Rate of change arteriel pressure In mmHg each 3,6 months Rate of change of the time in range, time above range and time below range 6 months data of the freestyle libre
Rate of change in weight in kg In kg each 3,6 months Concentration of Triglyceride In g/L each 3,6 months Anxiety and depression scale questionnary 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months HAD - Hospital Anxiety and Depression scale
Eating behavior questionnaire 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months DEBQ-Dutch Eating Behaviour Questionnaire
Trial Locations
- Locations (1)
UHM Montpellier
🇫🇷Montpellier, France