Accuracy of Capillary Blood Glucose Test When Fasting in Diabetes Patients or General Population: Performance Evaluation of G300 Based on ISO 15197:2013 Standards

Young-min Jee; Min-hee Seo; Byung-wook Yoo; Sung-ho Hong; Choo-yon Cho; Yong-jin Cho; Jung-eun Oh; Kyung-suk Shin

doi:10.15384/kjhp.2017.17.4.259

Korean J Health Promot > Volume 17(4); 2017 > Article

Jee, Seo, Yoo, Hong, Cho, Cho, Oh, and Shin: Accuracy of Capillary Blood Glucose Test When Fasting in Diabetes Patients or General Population: Performance Evaluation of G300 Based on ISO 15197:2013 Standards

Original Article

Korean Journal of Health Promotion 2017;17(4):259-268.

Published online: December 28, 2017

DOI: https://doi.org/10.15384/kjhp.2017.17.4.259

Accuracy of Capillary Blood Glucose Test When Fasting in Diabetes Patients or General Population: Performance Evaluation of G300 Based on ISO 15197:2013 Standards

Young-min Jee^1,², Min-hee Seo^1,², Byung-wook Yoo^1,²

, Sung-ho Hong^1,², Choo-yon Cho^1,², Yong-jin Cho^1,³, Jung-eun Oh^1,³, Kyung-suk Shin^1,⁴

¹Department of Family Medicine, Soonchunhyang University College of Medicine, Asan, Korea.

²Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.

³Department of Family Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.

⁴Department of Family Medicine, Soonchunhyang University Gumi Hospital, Soonchunhyang University College of Medicine, Gumi, Korea.

Corresponding author: Byung-wook Yoo, MD. International Health Care Center, Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, 59 Daesagwan-ro, Yongsan-gu, Seoul 00401, Korea.
Tel: +82-2-709-9158, Fax: +82-2-795-3687, dryoo@schmc.ac.kr

Received August 04, 2017 Accepted September 24, 2017

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

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.

Keywords: Blood glucose self-monitoring, Diabetes mellitus, Medical device, Electrochemical techniques

NOTES

Research grant benefits : Green Cross Medical Science(IRB number : SCHUH 2016-10-016-004).

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Figure 1

System accuracy plot and consensus error grid analysis of G300. The letter A means ‘error grid zone A’ and the letter B means ‘error grid zone B’. Error grid analysis showed that all values (100%) are within zone A.

Abbreviation: conc., concentration.

Figure 2

Interference of hematocrit. Interval 1 glucose concentration is 30–50 mg/dL, interval 2 is 96–144 mg/dL and interval 3 is 280–420 mg/dL. Difference from hematocrit 40% was within ±10 mg/dL in interval 1 and difference from hematocrit 40% was within ±10% in interval 2 and 3.

Figure 3

Dose-response tests of substances exceeding acceptance criteria.

Figure 4

System accuracy plot, consensus error grid analysis (CEG) and correlation between user and technician. The letter A means ‘error grid zone A’ and the letter B means ‘error grid zone B’. Error grid analysis showed that all values (100%) are within zone A.

Abbreviation: conc., concentration.

Table 1

Within-run precision of G300

Abbreviations: YSI, yellow springs instruments; SD, standard deviation; CV, coefficient of variation.

Acceptance criteria: <100 mg/dL: SD less than 5 mg/dL, ≥100 mg/dL: CV less than 5%. The numbers in the farthest left of the table represent 5 consecutive intervals of concentration levels (30–50 mg/dL, 51–110 mg/dL, 111–150 mg/dL, 151–250 mg/dL, 251–400 mg/dL) to which blood glucose concentrations sampled from patients belong to.

Table 2

Day to day precision of G300

Abbreviations: Conc., concentration; SD, standard deviation; CV, coefficient of variation.

Acceptance criteria: <100 mg/dL: SD less than 5 mg/dL, ≥100 mg/dL: CV less than 5%. The intervals 1 to 3 represent 3 intervals of blood glucose concentrations (30–50 mg/dL, 96–144 mg/dL, 280–420 mg/dL) and the numbers next to them are blood glucose concentrations of the samples of controls provided by the manufacturers accordingly to each intervals.

Table 3

System accuracy of G300

Table 4

Interference test of 24 possible interfering substances

Abbreviations: Conc., concentration; EDTA, ethylenediaminetetraacetic acid; L-DOPA, L-3, 4-dihydroxyphenylalanine; DOPA, dihydroxyphenylalanine.

Glucose low: 50–100 mg/dL, high: 250–350 mg/dL.

^aEach result from Lot1, Lot2, Lot3, and AVG means average of difference from control sample 10 times repeated measurement. Acceptance criteria is that difference from control sample was within ±10 mg/dL in low glucose interval (<100 mg/dL) and difference from control sample was within ±10% in high glucose interval (≥100 mg/dL).