Endocrinology, Type 2 Diabetes
Conditions
Keywords
Sensor, Therapeutic education, Diabete, Glucose
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
Interventions
DEVICEFreestyle Libre 2
The FSL will be placed on patient for 28 days to measure interstitial glucose
OTHERTherapeutic education
Therapeutic education
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of change in glycated hemoglobine at 3 months | 3 months | biological control of glycated hemoglobin in a laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 glycated hemoglobin at 6 months | 6 months | biological control |
| Rate of change in weight in kg | In kg each 3,6 months | — |
| Quality of Life questionnary | Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months | EQVOD - Scale of Quality of Life, Obesity and Dietetics |
| 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 | 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 |
Countries
France
Contacts
Primary ContactSULTAN Ariane, PU-PH
Outcome results
None listed