NCT01628341已完成不适用
French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,424
- 试验地点
- 1
- 主要终点
- Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)
研究概览
简要总结
This non-interventional study is conducted in Europe. The study is both retrospective and prospective.
The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
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
- •Patients with Type 1 or Type 2 Diabetes Mellitus
- •Patients treated by insulin for at least 12 months
- •Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements
- •Patients able to complete the questionnaires
- •Patients who have accepted to participate to the survey (signature of an information notice)
排除标准
- •Patients with Type 2 Diabetes Mellitus not treated with insulin
- •Females who are currently pregnant or lactating or who were pregnant during the previous year
研究组 & 干预措施
Patients with diabetes (type 1 and 2)
干预措施: insulin (Drug)
结局指标
主要结局
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)
时间窗: During the one-month follow-up after inclusion in study
次要结局
- Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia(During the one-month follow-up after inclusion in study)
- Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia(During the one-month follow-up after inclusion in study)
- Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia(During the one-month follow-up after inclusion in study)
- Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)(During the one-month follow-up after inclusion in study)
- Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia(During the one-month follow-up after inclusion in study)
- Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes(During the one-month follow-up after inclusion in study)
- Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes(During the one-month follow-up after inclusion in study)
- Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)(During the one-month follow-up after inclusion in study)
- Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode)(During the one-month follow-up after inclusion in study)
- Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver(During the one-month follow-up after inclusion in study)
- Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life(During the one-month follow-up after inclusion in study)
- Change in planned daily activities; work: effectiveness, missing hours or days for sick leave(During the one-month follow-up after inclusion in study)
研究者
研究点 (1)
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