Clinical Evaluation of Bayer G3 / Tatsu System and BGMs From Other Companies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)
研究概览
简要总结
The purpose of this study was to test the performance of an investigational Bayer Blood Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was to obtain glucose samples from subjects with diabetes across the meter operating ranges. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). All lancings and testing were performed by study staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Diagnosis of type 1 or type 2 diabetes mellitus
- •18 years of age or older
- •Willing to follow all study procedures
排除标准
- •Received an investigational drug or device within the last 30 days
- •Current use or recent exposure to any prescription medication within 24 hours prior to screening that in the opinion of the investigator could have an influence on the subject's ability to participate in the study or on the performance on the test device
- •Positive pregnancy test obtained at screening (test performed for females only, except if surgically sterile or three years past menopause)
- •Hematocrit <32% or >55%
- •Inadequate veins (in the opinion of the investigator or designated study staff) for venous blood withdrawal or intravenous catheter insertion
- •Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g. percutaneous transluminal coronary angioplasty [PTCA], stent placement) or coronary artery bypass graft (CABG) within the past 6 months
- •Cerebrovascular accident within the past 6 months
- •Diagnosis of the following diabetic autonomic neuropathies: symptomatic orthostatic hypotension, heart rate anomalies, gastroparesis
- •Being treated for malignancy, except basal cell or squamous cell skin cancers
- •Major surgical operation within 30 days prior to screening
- •Active alcohol abuse or substance abuse (as judged by the principal investigator)
- •Severe mental illness, mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation (as judged by principal investigator)
- •Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity, as judged by principal investigator (reason for exclusion will be clearly documented by investigator or designee)
- •Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
结局指标
主要结局
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)
时间窗: 6 hours
Using samples with BG \< 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.
次要结局
- MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL(6 hours)
- MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL(6 hours)
- Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)(6 hours)
- Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements(1 hour)