NCT07353125已完成不适用
Evaluation of the Blood Glucose Monitoring System LS-9 of Leison Biotech Co., Ltd. in Accordance With DIN EN ISO 15197:2015
Institut fur Diabetes Karlsburg GmbH0 个研究点目标入组 219 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
研究概览
简要总结
This study assesses the system accuracy and performance evaluation by the user 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
研究者
Matthes Kenning
Eckhard Salzsieder, Principal Investigator
Institut fur Diabetes Karlsburg GmbH
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