NCT01696266已完成不适用
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29,304
- 试验地点
- 1
- 主要终点
- Incidence of any hypoglycaemic event
研究概览
简要总结
This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
- •Patients giving informed consent to participate in the survey
排除标准
- •Non-ambulatory patients
- •Illiterate patients and patients otherwise unable to complete a written survey
结局指标
主要结局
Incidence of any hypoglycaemic event
时间窗: In the 4 weeks prior to and following the baseline visit (Week 0)
次要结局
- Incidence of probable symptomatic hypoglycaemic events(In the 4 weeks prior to and following the baseline visit)
- Incidence of all severe hypoglycaemic events(In the 6 months prior to and 4 weeks following the baseline visit)
- Incidence of hypoglycaemic events requiring hospital admission(In the 6 months prior to and 4 weeks following the baseline visit)
- Difference in the reported incidence rates of any hypoglycaemia(In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit)
研究者
研究点 (1)
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