NCT02099409已完成不适用
Open Label Single Center Randomized Cross Over Study to Validate Current Algorithms and Evaluate Safety and Efficacy of Closed Loop Insulin Delivery (FlorenceD2 System) in Children With Type 1 Diabetes Between 6 - 12 Years of Age
Centre Hospitalier du Luxembourg4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Time spent in normal glucose range ( mg/dl)
研究概览
简要总结
The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 - ≤12 years
- •With type 1 diabetes for 6 months or more and
- •Pump user for at least 6 months.
- •HbAc1 should be <11 %.
- •No medication or physical or psychological disease should be present, which could interfere with the study.
排除标准
- 未提供
研究组 & 干预措施
Starting with FLORENCED2 followed by open loop
Experimental
Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop.
干预措施: FLORENCED2 (Device)
Start open loop followed by FLORENCED2
Experimental
Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
干预措施: FLORENCED2 (Device)
结局指标
主要结局
Time spent in normal glucose range ( mg/dl)
时间窗: At least 5 hours between 7 pm and 7 am
Glucose will be measured with a Continuous glucose monitoring device
次要结局
- glucose variability ( excursions in mg/dl)(7 pm - 7 am)
- Time spent in low glucose range (< 60 mg/dl)(7 pm till 7 am)
- time spent in high glucose range (>180mg/dl)(7 pm - 7 am)
- time spent in low glucose range (<70 mg/dl)(7 pm till 7 am)
研究者
Carine de Beaufort
MD , PhD
Centre Hospitalier du Luxembourg
研究点 (4)
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