System Accuracy Evaluation of Accu-Chek Aviva Nano (Roche Diagnostics), Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan), Contour Next Link 2.4 (Bayer Consumer Care), One Additional CE-marked Blood Glucose Monitoring System 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
- 120
- 试验地点
- 2
- 主要终点
- System accuracy criteria (see description)
研究概览
简要总结
The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), 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. In this study, system accuracy evaluation will be performed with CE-marked BGMS (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and Accu-Chek Mobile with three different reagent system lots for each BGMS.
The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.
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 (concentration category 2):
- •Coronary heart disease
- •Condition after myocardial infarction
- •Cerebral incidence
- •Peripheral arterial occlusive disease
- •Hypoglycemia unawareness
结局指标
主要结局
System accuracy criteria (see description)
时间窗: For each subject, the experimental phase has an expected duration of up to 6 hours
System accuracy criteria Following 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. Applying ISO 15197:2003 accuracy criteria: 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 \< 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l).
次要结局
未报告次要终点