NCT01909687已完成不适用
Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich
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 163 人开始时间: 2013年7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
- 163
- 试验地点
- 2
- 主要终点
- Analysis of system accuracy
研究概览
简要总结
System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013
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
Analysis of system accuracy
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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