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临床试验/NCT01016457
NCT01016457Unknown4 期

Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年12月最近更新:
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

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

申办方类型
Other Gov

研究点 (1)

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