کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1967699 1538751 2007 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Clinical evaluation of the eBsensor hand-held blood glucose monitoring system
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی زیست شیمی
پیش نمایش صفحه اول مقاله
Clinical evaluation of the eBsensor hand-held blood glucose monitoring system
چکیده انگلیسی

BackgroundHome glucose monitoring system is increasingly recognized as an important tool for glycemic control. We evaluated the clinical performance of the eBsensor glucose monitoring system.MethodsFingertip capillary blood glucose concentrations from 282 subjects were measured using eBsensor glucose monitoring system and compared against predicate devices and the Yellow Springs Instruments (YSI) 2300 blood glucose analyzer. Accuracy and precision of the eBsensor glucose monitoring system were assessed using several methods. The comparative study between the eBsensor and 2 currently marketed monitoring systems was performed.ResultsThe 282 eBsensor readings covered a wide range from 2.6 to 24.4 mmol/l. Deming regression and Pearson correlation analyses showed a linear relationship between the eBsensor readings and the YSI reference method (eBsensor = 0.9496 YSI + 0.4127 mmol/l; r = 0.98). Error Grid analysis demonstrated that 100% of the eBsensor readings in clinically acceptable zones A and B. The CVs for the 6 lots of strips were within the satisfactory interval (< 6%). The comparative study showed that the eBsensor readings correlated well with the OneTouch Ultra values (r = 0.97) and the Glucocard II values (r = 0.97).ConclusionseBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Clinica Chimica Acta - Volume 377, Issues 1–2, 2 February 2007, Pages 170–173
نویسندگان
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