NCT02230631已完成不适用
A 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
- 704
- 主要终点
- The percentage of patients experiencing at least 1 hypoglycaemic event
研究概览
简要总结
This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent obtained before any study-related activities
- •The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey
排除标准
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Illiterate patients and patients otherwise unable to complete a written survey
- •Non-ambulatory patients
- •Simultaneous participation in any other clinical study with an investigational product
结局指标
主要结局
The percentage of patients experiencing at least 1 hypoglycaemic event
时间窗: During 4 weeks from baseline visit
次要结局
- Documented symptomatic hypoglycaemic events(In the 4 weeks following the baseline visit (Patient Diary))
- Difference in the reported incidence rates of hypoglycaemia(In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit)
- Severe hypoglycaemic events(In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit)
- Non-severe hypoglycaemic events(In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit)
- Nocturnal hypoglycaemic events(In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit)
- All hypoglycaemic events (any type)(In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit)
- Hypoglycaemic events requiring hospital admission(In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit)
- Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms(In the 4 weeks following the baseline visit (Patient Diary))
研究者
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