NCT05158478已完成不适用
Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100
Institut fur Diabetes Karlsburg GmbH2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年2月22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
- 1
- 试验地点
- 2
- 主要终点
- repeatability precision
研究概览
简要总结
This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197
详细描述
This study assesses the repeatability precision the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines
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 patients with clinical indication for blood glucose testing
- •Signed form of consent
- •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
- •Severe acute disease (at study physician's discretion)
- •Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
- •Current constitution that does not allow participating in the study (e.g. hematocrit out of
- •the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
- •Being unable to give informed consent
- •Age younger than 18 years
- •Legally incompetent
结局指标
主要结局
repeatability precision
时间窗: day 1
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
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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