NCT01016457Unknown4 期
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- HbA1C
研究概览
简要总结
The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of diabetes for more than 6 months
- •Use of insulin pump for more than 3 months
排除标准
- 未提供
结局指标
主要结局
HbA1C
时间窗: Start of study, after 3 months, after 6 months
次要结局
- Quality of life(Before and after connecting to sensor)
- Number of night hypoglycemias(During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting)
- Mean glucose level(During the first week of connecting to sensor and during the last week of connecting)
研究者
研究点 (1)
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