NCT02439177终止不适用
Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
研究概览
简要总结
The aim of this study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 subjects with type 1 or type 2 diabetes, for the evaluation of System Accuracy also healthy subjects
- •Signed and dated informed consent form
- •For small modifications of the insulin doses to achieve certain blood glucose values (System Accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy - I.C.T.) or insulin pump therapy (continuous subcutaneous insulin infusion - C.S.I.I.)
排除标准
- •Pregnancy or lactation period
- •Severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test.
- •Severe chronic illness besides Diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test.
- •Mental incapacity or language barriers precluding adequate compliance with the test procedures
- •Legal incompetence or limited legal competence
- •Dependency from the Sponsor or the clinical Investigator (e.g. co-workers of the Sponsor or the clinical research centre)
- •For User Performance evaluation: Subjects having participated in a study with Omnitest® 5 before.
- •For System Accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness
- •Anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.
结局指标
主要结局
System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
时间窗: up to 7 hours
User Performance of blood glucose monitoring system indicated by patient
时间窗: up to 7 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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