NCT06037486已完成不适用
Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL60 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 101 人开始时间: 2022年10月17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
- 101
- 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 a blood glucose monitoring systems pursuant to ISO 15197
详细描述
This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.
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. Eckhard Salzsieder, Director
Institut fur Diabetes Karlsburg GmbH
研究点 (2)
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