NCT02290067已完成不适用
EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF 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
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- User performance of blood glucose monitoring systems indicated by patient [questionnaire]
研究概览
简要总结
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.
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
- •Subjects with type 1 or type 2 diabetes and 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) or insulin pump therapy (continuous subcutaneous insulin infusion)
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 patient caused by the test
- •Mental incapacity or language barriers precluding adequate compliance with the test procedures
- •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 patient caused by the test
- •Legal incompetence or limited legal competence
- •Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
- •For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems
- •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
结局指标
主要结局
User performance of blood glucose monitoring systems indicated by patient [questionnaire]
时间窗: up to 4 hours
System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
时间窗: 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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