Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients

Conditions
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Endocrinology, Type 2 Diabetes

Intervention / Treatment
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* Device: Freestyle Libre 2
* Other: Therapeutic education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: People living with diabete standard TPE<br>HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months | Other: Therapeutic education<br>* Therapeutic education<br>|
| Experimental: People living with diabete standard TPE + FSL 28 days<br>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 | Device: Freestyle Libre 2<br>* The FSL will be placed on patient for 28 days to measure interstitial glucose<br>Other: Therapeutic education<br>* Therapeutic education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in glycated hemoglobine at 3 months | biological control of glycated hemoglobin in a laboratory | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change of the time in range, time above range and time below range | data of the freestyle libre | 6 months | 
| Rate of change in glycated hemoglobin at 6 months | biological control | 6 months | 
| Rate of change in weight in kg |  | In kg each 3,6 months | 
| Quality of Life questionnary | EQVOD - Scale of Quality of Life, Obesity and Dietetics | 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 |  | In mmHg each 3,6 months | 
| Concentration of of LDL cholesterol |  | In g/L each 3,6 months | 
| Concentration of Triglyceride |  | In g/L each 3,6 months | 
| Anxiety and depression scale questionnary | HAD - Hospital Anxiety and Depression scale | 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months | 
| Quality of Life questionnary | EQ-5D - EuroQoL-5D | 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 | 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensor, Therapeutic education, Diabete, Glucose