title: Clinical evaluation of the eBsensor hand-held blood glucose monitoring system.
abstract: BACKGROUND
  Home glucose monitoring system is increasingly recognized as an important tool for glycemic control. We evaluated the clinical performance of the eBsensor glucose monitoring system.
  
  
  METHODS
  Fingertip 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.
  
  
  RESULTS
  The 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).
  
  
  CONCLUSIONS
  eBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.
authors.affiliation: Wei-Gong Memorial Hospital, Miaoli, and The Institude of Biotechnology, College of Life Science, National Tsing Hua University, Hsinchu, Taiwan.
authors.forename: Chien-Chih
authors.initials: CC
authors.lastname: Chen
authors.forename: Der-Yan
authors.initials: DY
authors.lastname: Tai
authors.forename: Ping
authors.initials: P
authors.lastname: Ho
authors.forename: Yiu-Kay
authors.initials: YK
authors.lastname: Lai
authors.forename: Jui-Jane
authors.initials: JJ
authors.lastname: Lin
authors.forename: Simon J T
authors.initials: SJ
authors.lastname: Mao
authors.forename: Chia-Chi
authors.initials: CC
authors.lastname: Lin
authors.forename: Yu-Chen
authors.initials: YC
authors.lastname: Hsieh
authors.forename: Hsiang-Cheng
authors.initials: HC
authors.lastname: Chiang
authors.forename: Ken-Shwo
authors.initials: KS
authors.lastname: Dai
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male