Overview
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
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
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