NCT06146933已完成不适用
Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL22 gemäß DIN EN ISO 15197:2015.
Institut fur Diabetes Karlsburg GmbH2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2023年11月1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
- 113
- 试验地点
- 2
- 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 a blood glucose monitoring system pursuant to ISO 15197
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 patients with hypo-, eu- or hyperglycaemia
- •The written informed consent had to be signed
- •The volunteers must be older than 18 years
- •The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved
排除标准
- •Pregnancy or lactation
- •Acute or chronic diseases with the risk of aggravation by the measure
- •A current constitution that does not allow participating in the study
- •Participation in another study or activity with the blood glucose measuring system evaluated in the present study
- •Application of substances listed in Appendix A of DIN EN ISO 15197:2015
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 the blood glucose monitor
次要结局
未报告次要终点
研究者
Matthes Kenning
Dr. Kerstin Rebrin
Institut fur Diabetes Karlsburg GmbH
研究点 (2)
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