Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Fear of hypoglycemia score
研究概览
简要总结
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of 5 questionnaires including fear of hypoglycemia-2 questionnaire.
详细描述
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of questionnaires including fear of hypoglycemia-2 questionnaire.
Biobanking of urine/blood Collection of key medical informations by investigators
Questionnaires :
- socio-economic status
- Fear of hypoglycemia-2
- Anxiety Depression scale (HAD)
- Health survey (SF36, SF12)
- Satisfaction to treatment (DHP-18)
- Dutch Eating Behavior Questionnaire (DEBQ)
- Pittsburgh quality of sleep (PSQI)
- Blood Glucose diary
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Fear of hypoglycemia score
时间窗: 2 weeks
hypoglycemia questionnaire and hypoglycemia reported by patients
次要结局
- Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)(2 weeks)
- quality of life(from 2 weeks up to 3 months)