Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 8
- 主要终点
- Time spent in blood glucose range
研究概览
简要总结
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 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
Time spent in blood glucose range
时间窗: Change over 6 months
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.
Pediatric Quality of Life Inventory
时间窗: Change over 6 months
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
次要结局
- Pittsburgh Sleep Quality Index(Change over 6 months)
- A1c(Change over 6 months)
- Diabetes Distress Scale(Change over 6 months)
- Patient Health Questionnaire 9(Change over 6 months)
- Problem Areas in Diabetes(Change over 6 months)
- State-Trait Anxiety Inventory(Change over 6 months)
- General and diabetes-specific technology use(Change over 6 months)
- Hypoglycemic Fear Survey(Change over 6 months)
- Hypoglycemic Confidence Questionnaire(Change over 6 months)
- Glucose Monitoring System Satisfaction Survey(Change over 6 months)
研究者
Korey Hood
Professor
Stanford University