지영민1,2, 서민희1,2, 유병욱1,2, 홍성호1,2, 조주연1,2, 조용진1,3, 오정은1,3, 신경숙1,4

1순천향대학교 의과대학 가정의학교실, 2순천향대학교 의과대학 서울병원 가정의학과, 3순천향대학교 의과대학 천안병원 가정의학과, 4순천향대학교 의과대학 구미병원 가정의학과

Background: Self-monitoring of blood glucose plays an
important role in management of diabetes mellitus.
Blood glucose measurement is based on using plasma
glucose separated from whole blood, but many people
with diabetes and health care providers use a portable
glucose meter for convenience. The aim of this study
was to evaluate the accuracy and agreement of G300
portable glucose monitoring system against standard venous
glucose testing methods, based on ISO 15197:2013
standards.
Methods: This study was the evaluation of G300 system
accuracy following ISO 15197:2013 standards. We
estimated
precision, system accuracy, hematocrit interference,
interfering substances, and user performance.
Results: In repeatability precision evaluation of those
glucometers, standard deviation was 2.9-3.7 mg/dL at
glucose levels under 100 mg/dL and coefficient of variation
was 1.7-3.2% at glucose levels over 100 mg/dL,
respectively. In accuracy evaluation, 99.5% of difference
values between results of G300 portable glucose
monitoring system and clinical laboratory were within 95%.
Consensus Error grid analysis showed that all values
(100%) are within zone A. Hematocrit range between 20%
and 60% did not cause interference. These results
were acceptable for the ISO15197:2013 criteria in all glucose
concentrations.
Conclusions: This study showed that G300 can provide
reliable blood glucose results for patients and health
care providers to manage diabetes mellitus, satisfying the
ISO 15197:2013 criteria.
Korean J Health Promot 2017;17(4):259-268
Keywords: Blood glucose self-monitoring, Diabetes mellitus,
Medical device, Electrochemical techniques