User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Acceptance criteria defined by ISO 15197:2013 (see description)
研究概览
简要总结
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8.
The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
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
- •Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
- •For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
- •Minimum age of 18 years
- •Signed informed consent form
- •Legally competent and capable to understand character, meaning and consequences of the study
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)
- •Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- •Incapability of giving informed consent
- •< 18 years
- •Legally incompetent
- •Accommodated in an institution (e.g. psychiatric clinic)
- •Language barriers potentially compromising an adequate compliance with study procedures
- •Dependent from investigator or sponsor
- •For provoked blood glucose excursions 50 - 80 mg/dl:
- •Coronary heart disease
- •Condition after myocardial infarction
- •Cerebral incidence
- •Peripheral arterial occlusive disease
- •Hypoglycemia unawareness
结局指标
主要结局
Acceptance criteria defined by ISO 15197:2013 (see description)
时间窗: For each subject, the experimental phase has an expected duration of up to 3 hours
95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations \< 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).
次要结局
未报告次要终点