Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of change in glycated hemoglobine at 3 months
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
结局指标
主要结局
Rate of change in glycated hemoglobine at 3 months
时间窗: 3 months
biological control of glycated hemoglobin in a laboratory
次要结局
- 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)
- Rate of change in glycated hemoglobin at 6 months(6 months)
- Rate of change arteriel pressure(In mmHg each 3,6 months)
- Anxiety and depression scale questionnary(14 questions (high score depression, anxiety - low score good health) performed at 3,6 months)
- Rate of change of the time in range, time above range and time below range(6 months)
- Rate of change in weight in kg(In kg each 3,6 months)
- Concentration of Triglyceride(In g/L each 3,6 months)
- Eating behavior questionnaire(33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months)