NCT01444443已完成不适用
DiaCon Closed-Loop Study
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
- 12
- 试验地点
- 2
- 主要终点
- Number of hypoglycemic events
研究概览
简要总结
The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Type 1 diabetes duration > 2 years
- •HbA1c < 8%
- •Insulin pump user > 1 year
排除标准
- •Use of medication affecting glucose metabolism
- •Pregnancy or nursing
研究组 & 干预措施
Closed-loop glucose control
Experimental
Blood glucose controlled by control algorithm.
干预措施: Closed-loop control (Device)
Open-loop glucose control
Active Comparator
Blood glucose controlled by patient
干预措施: Open-loop control (Other)
结局指标
主要结局
Number of hypoglycemic events
时间窗: 22:00-07:00
次要结局
- Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI(22:00-07:00)
研究者
Signe Schmidt
MD, Clinical research fellow
Hvidovre University Hospital
研究点 (2)
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