Gerber Pump Trial: Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Real-Time Sensor Augmentation (RTSA) in 0-3 Years Old Diabetes Patients; A One Year Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduce blood glucose variability among 0-3 year old children with type I diabetes.
研究概览
简要总结
The purpose of this study is to see if the use of a real-time glucose sensor improves diabetes control in young children (less than 4 years old) with Type I diabetes when they are initiated on insulin pump therapy.
详细描述
A randomized controlled clinical trial involving patients 0-3 yrs old with type 1 diabetes. After successful screening the subjects will be randomized into one of two groups: a CSII group alone and a CSII group + Real Time Sensor Augmentation group (RTSA) group. The CSII group will serve as the control for the CSII+RTSA group. The trial will last for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than 4 years of age with Type I diabetes for at least 3 months
排除标准
- •Children greater than 4 years of age
- •Monogenic diabetes
研究组 & 干预措施
Control
Observational arm
Real-time glucose sensor
Subjects wear real-time glucose sensor
干预措施: Real-time glucose sensor (Device)
结局指标
主要结局
Reduce blood glucose variability among 0-3 year old children with type I diabetes.
时间窗: 1 year
次要结局
- Number of adverse events(1 year)