NCT05031000已完成不适用
Cheap Equals Bad? Comparative System Accuracy of POCT Blood Glucose Monitoring Systems Under the Aspect of Aspect of Pricing: Discounter Versus Brand
Institut fur Diabetes Karlsburg GmbH1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年9月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Analysis of system accuracy based on DIN EN ISO 15197
研究概览
简要总结
This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, with clinical indication for blood glucose measurement
- •Signed informed consent form
- •Minimum age of 18 years
- •Subjects are legally competent and capable to understand character, meaning and consequences of the study.
排除标准
- •Pregnancy or lactation period
- •Severe acute disease (at the study physician's discretion)
- •Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
- •Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- •A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
- •Being unable to give informed consent
- •< 18 years
- •Legally incompetent
研究组 & 干预措施
Subject POCT glucometer measurement
Experimental
Blood glucose measurement POCT glucometer
干预措施: blood glucose measurement: POCT (Diagnostic Test)
Subject POCT glucometer measurement
Experimental
Blood glucose measurement POCT glucometer
干预措施: blood glucose measurement: reference (Diagnostic Test)
结局指标
主要结局
Analysis of system accuracy based on DIN EN ISO 15197
时间窗: day 1
Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197
次要结局
未报告次要终点
研究者
研究点 (1)
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