NCT05219526已完成不适用
Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015
Institut fur Diabetes Karlsburg GmbH2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2022年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Measurement performance: System accuracy
研究概览
简要总结
The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.
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
- 否
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
结局指标
主要结局
Measurement performance: System accuracy
时间窗: 4-6 hours
Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment
次要结局
未报告次要终点
研究者
Matthes Kenning
Director, PhD
Institut fur Diabetes Karlsburg GmbH
研究点 (2)
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