DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Accuracy of the GlucoWatch G2 Biographer and CGMS sensors
研究概览
简要总结
Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.
详细描述
The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.
The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight >= 16.0 kg (35 lbs)
- •Body mass index between the 10th to 90th percentile for age and sex
- •HbA1c within normal limits
- •Hematocrit within normal limits
排除标准
- •History of diabetes
- •History of positive islet cell antibody testing
- •Family history of Type 1 or Type 2 diabetes in a sibling or parent
- •Medication use of any type in the 7 days prior to study entry
- •Skin abnormalities contraindicating device use
结局指标
主要结局
Accuracy of the GlucoWatch G2 Biographer and CGMS sensors
次要结局
未报告次要终点