Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- System accuracy criteria
研究概览
简要总结
The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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, with type 1 diabetes, type 2 diabetes (or subjects without diabetes)
- •Signed informed consent form
- •Minimum age of 18 years
- •Subjects are legally competent and capable to understand character, meaning and consequences of the study.
- •If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
- •Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
- •Signature of subjects to document consent with these procedures on informed consent form.
排除标准
- •Pregnancy or lactation period
- •Severe acute disease (at the study physician's discretion)
- •Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
- •Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- •Being unable to give informed consent
- •< 18 years
- •Legally incompetent
- •Being committed to an institution (e.g. psychiatric clinic)
- •Language barriers potentially compromising an adequate compliance with study procedures
- •Dependent on investigator or sponsor
- •If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2), subjects with type 1 diabetes, suffering from:
- •Coronary heart disease
- •Condition after myocardial infarction
- •Condition after cerebral events
- •Peripheral arterial occlusive disease
- •Hypoglycemia unawareness
结局指标
主要结局
System accuracy criteria
时间窗: For each subject, the experimental phase has an expected duration of up to 6 hours
Based on EN ISO 15197:2015 (ISO 15197:2013) (E), the BGMS shall meet both of the following criteria: Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). Each lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.
次要结局
未报告次要终点