NCT01789021已完成不适用
Analytical Performance Evaluation of Blood Glucose Monitoring Systems
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年2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
- 120
- 试验地点
- 2
- 主要终点
- Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value
研究概览
简要总结
In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.
研究设计
- 研究类型
- Interventional
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
- •18 years of age or older
- •Male or female subjects with type 1 or type 2 diabetes or healthy subjects
- •For BG adjustment people with type 1 diabetes
排除标准
- •Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
- •Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
- •Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
- •For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
- •Legal incompetence or limited legal competence
- •Age < 18 years
- •Dependency from the sponsor or the clinical investigator
- •Mental incapacity or language barriers precluding adequate compliance with the study procedures
结局指标
主要结局
Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value
时间窗: For each subject, the experimental phase has an expected duration of up to 6 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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