NCT00772356已完成不适用
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
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
- 14
- 试验地点
- 1
- 主要终点
- Comparison of glucose infusion rate necessary to keep blood glucose constant
研究概览
简要总结
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 18-65 years of age
- •Type I diabetes mellitus
- •Currently on continuous subcutaneous insulin infusion therapy
排除标准
- •Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
- •Use of systemic corticoids in last 3 months
- •Treatment with medication known to interfere with glucose metabolism
研究组 & 干预措施
A
Experimental
干预措施: Accu-Chek Spirit Insulin Pump (Device)
B
Active Comparator
干预措施: Comparator insulin pump (Device)
结局指标
主要结局
Comparison of glucose infusion rate necessary to keep blood glucose constant
时间窗: Throughout study
次要结局
- Serum insulin and free fatty acid levels(Throughout study)
研究者
研究点 (1)
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