NCT00468754已完成不适用
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Variability of blood glucose characterised by the standard deviation of the mean blood glucose
研究概览
简要总结
This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetic patients, 18-60 years of age
- •Diabetic for >2 years
- •Treated with CSII for >=6 months
- •HbA1c <8.5%
排除标准
- •Treatment with daily insulin injections
- •Inability to handle pump therapy
- •Untreated retinopathy
研究组 & 干预措施
A
Experimental
干预措施: Insulin pumps (Device)
B
Experimental
干预措施: Insulin pumps (Device)
结局指标
主要结局
Variability of blood glucose characterised by the standard deviation of the mean blood glucose
时间窗: Length of study
次要结局
- HbA1c(Length of study)
- Frequency of severe hypoglycemia(Length of study)
- Daily insulin requirement(Length of study)
- Mean BG during the last month of the respective treatment period(Length of study)
研究者
研究点 (4)
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