Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
研究概览
简要总结
The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.
详细描述
This trial will evaluate the performance of both the CONTOUR NEXT BGMS and CONTOUR PLUS ELITE BGMS using blood from neonates within a hospital ward, e.g. routine/newborn nurseries, Special Care Nurseries, Neonatal Intensive Care Unit (NICU). The investigational BGMSs will be tested by a Point-of-Care operator using residual heel-stick capillary blood samples from neonates who underwent routine prescribed testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Days 至 27 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing.
- •Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.
排除标准
- •Samples from subjects who are ≥ 28 days of age.
- •Samples from subjects who have previously been enrolled into this study.
结局指标
主要结局
Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
时间窗: 1 day
At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).
Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values
时间窗: 1 day
At least 95% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \< 75 mg/dL(4.16 mmol/L).
次要结局
未报告次要终点