Clinical evaluation of the eBsensor hand-held blood glucose monitoring system
- Resource Type
- Authors
- Hsiang-Cheng Chiang; Ping Ho; Ken-Shwo Dai; Der-Yan Tai; Chia-Chi Lin; Chien-Chih Chen; Jui-Jane Lin; Simon J.T. Mao; Yiu-Kay Lai; Yu-Chen Hsieh
- Source
- Clinica chimica acta; international journal of clinical chemistry. 377(1-2)
- Subject
- Blood glucose monitoring
Male
Accuracy and precision
medicine.diagnostic_test
business.industry
Glucose meter
Grid analysis
Blood Glucose Self-Monitoring
Biochemistry (medical)
Clinical Biochemistry
Hand held
General Medicine
Biochemistry
Deming regression
Medicine
Humans
Female
business
Clinical evaluation
Biomedical engineering
Glycemic
- Language
- ISSN
- 0009-8981
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.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.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).eBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.