NCT03258853已完成不适用
Feasibility of Outpatient Automated Blood Glucose Control With the iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
研究概览
简要总结
The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children with cystic fibrosis related 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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
时间窗: Days 3-14
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
次要结局
- Mean CGM Glucose(Days 3-14)
- Standard Deviation(Days 3-14)
- Coefficient of Variation(Days 3-14)
- Number of Subjects With Mean CGMG <154 mg/dl(Days 3-14)
- Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl(Days 3-14)
- Percentage of Time Spent With CGM Glucose: < 54 mg/dl(Days 3-14)
- Percentage of Time Spent With CGM Glucose < 70 mg/dl(Days 3-14)
- Number of Subjects With Percentage of Time < 54 mg/dl < 1%(Days 3-14)
- Percentage of Time Spent With CGM Glucose > 250mg/dL(Days 3-14)
- Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater(Days 3-14)
- Number of Episodes of Self-reported Symptomatic Hypoglycemia(Days 3-14)
- Percentage of Time Spent With CGM Glucose >180 mg/dL(Days 3-14)
研究者
Melissa Susan Putman
Principal Investigator
Massachusetts General Hospital
研究点 (2)
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