Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- blood glucose level measured by StatStrip blood glucose meter
研究概览
简要总结
This study is to determine the validity of Nova StatStrip® blood glucose monitoring test system including the Nova StatStrip® glucose hospital meter and test strips in measuring Chinese neonatal capillary blood glucose levels by evaluating how the results compare to those obtained from laboratory hexokinase method. The study results will be the basis for the regulatory submission and registration of the Nova StatStrip® glucose hospital meter and test strips in testing the neonatal capillary whole blood specimens to the China Food and Drug Administration (CFDA).
Good clinical practice indicates that the performance of a point-of-care glucose monitoring test system be validated before clinical use. It is therefore important to perform a method comparison study to determine how the results obtained from a type of glucose monitoring test system compare to those from a laboratory hexokinase method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is within 28 days after birth.
- •The legal representative of the Subject agrees to sign two copies of the Informed Consent Form.
- •The Subject's capillary whole blood needs to be drawn via heel stick for routine clinical laboratory testing according to the prescription.
- •The legal representative of the Subject agrees that the Subject provides 300 µL capillary whole blood for glucose and haematocrit testing in addition to routine clinical laboratory testing.
排除标准
- •Subject/legal representative is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products;
- •Subject has already participated in this study.
结局指标
主要结局
blood glucose level measured by StatStrip blood glucose meter
时间窗: 6 months
plasma glucose level measured by a laboratory biochemistry analyzer
时间窗: 6 months
次要结局
- hematocrit of the heel-stick blood(6 months)