Clinical evaluation and alternative site blood glucose testing of the EasyPlus mini R2N blood glucose monitoring system.
BACKGROUND
The complications of diabetes are preventable by exact glycemic control, which can be provided by an accurate self-monitoring blood glucose system to promote self-care in the management of diabetes.


METHODS
We evaluated the accuracy and reliability of the EasyPlus mini R2N blood glucose self-monitoring system and compare glucose measurements between the fingertip, thenar, hypothenar and forearm. Over a 1-month period, 165 patients with Types 1 and 2 diabetes mellitus participated in this study.


RESULTS
EasyPlus mini R2N blood glucose results obtained from the fingertip correlated well with the laboratory reference (linear regression analysis: slope=1.03, intercept=-1.63 mg/dl, r(2)=0.970) and were comparable to the results generated from 2 other blood glucose meters. Clarke error grid analysis showed all EasyPlus mini R2N glucose results in clinically acceptable zones A and B (96.79% in zone A and 3.21% in zone B). The CVs of the within-run and total precision testing were within the acceptance criteria (<6%). As compared to the alternate site, the fingertip correlated well with the thenar and hypothenar values and the forearm value.


CONCLUSIONS
The EasyPlus mini R2N showed clinically acceptable accuracy and reliability as compared to the laboratory reference, and no significant or detectable glucose differences between alternate sites were observed.
Wei
Chien-Hua
CH
Wei-Gong Memorial Hospital, No 128, Xinyi Road, Toufen Town, Miaoli County, Taiwan.
Peng
Ting-Chun
TC
Wang
Peng-Yuan
PY
Lin
Jui-Jane
JJ
Chuang
Mei-Lin
ML
Chen
Chien-Chih
CC
D000531:Altitude; D001234:Aspergillus niger / Q000201:enzymology; D015374:Biosensing Techniques; D001774:Blood Chemical Analysis / Q000379:methods*; D001786:Blood Glucose / Q000032:analysis*; D004553:Electric Conductivity; D004563:Electrochemistry; D004566:Electrodes; D005260:Female; D005949:Glucose Oxidase / Q000378:metabolism; D006801:Humans; D016014:Linear Models; D008297:Male; D011934:Reagent Strips; D012680:Sensitivity and Specificity; D013997:Time Factors
D001786:Blood Glucose; D011934:Reagent Strips; D005949:Glucose Oxidase