Performance Evaluation of Blood Glucose Meters and HbA1c Point-of-care Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 910
- 试验地点
- 8
- 主要终点
- BGM Performace
研究概览
简要总结
This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as intended users who are unfamiliar with the system (lay users, for BGMs only). System usability will also be assessed for all BGMs (including lancing devices) and HbA1c devices.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-17 years, diagnosed with diabetes and able to manage condition independently (ideally at least 10% of total Arm 1 population)
- •≥18 years, diagnosed with diabetes
- •Able and willing to provide informed consent/assent
- •Naïve to the SMBG use of the investigational devices
- •10% naïve to any SMBG (defined as not having performed any SMBG in the last 24 months)
- •Haematocrit within 20-60%
- •Pre-screen BGM result qualifies for inclusion in any of the five glucose concentration ranges based on % of subjects required to meet the target number per concentration range
- •Able and willing to provide informed consent
- •Diagnosed or not diagnosed with diabetes
- •Haemoglobin values ≥ 8g/dL
- •Pre-screen HbA1c result qualifies for inclusion in the target HbA1c range and % of subjects required for the mid-range values
排除标准
- •<13 years
- •13-17 years and not diagnosed with diabetes or unable to manage condition independently
- •Previous use of investigational BGM for SMBG
- •Haematocrit outside normal range
- •Pre-screen BGM result falling in a glucose concentration range that already has sufficient participants.
- •<18 years
- •Haemoglobin value < 8g/dL
- •Pre-screen HbA1c result falling in a concentration range that already has sufficient participants.
研究组 & 干预措施
BGM Evaluation
干预措施: CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor) (Diagnostic Test)
HbA1c evaluation
干预措施: Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens) (Diagnostic Test)
结局指标
主要结局
BGM Performace
时间窗: 1 year
For BGMs: Performance accuracy is based on ISO 15197 criteria, mean relative bias, 95% limits of agreement, and regression slopes of each BGM with respect to two independently validated comparator BGMs (each investigational BGM will be compared to each comparator BGMs independently).
HbA1c Performance
时间窗: 1 year
For HbA1c: Performance accuracy is based on regression slopes, mean relative bias, 95% limits of agreement, and of each HbA1c device versus the reference method and the concordance between capillary and venous blood results.
次要结局
- Interpretation(1 year)
- Type of errors as observed(1 year)
- Number of errors as observed(1 year)
- Comprehension(1 year)
- Usability(1 year)
- Proportion of label comprehension(1 year)
- Number of errors as displayed.(1 year)
- Type of errors as displayed(1 year)