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临床试验/NCT00772356
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

Hoffmann-La Roche1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2008年1月最近更新:
适应症

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

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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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