Evaluation of New Blood Glucose Monitoring System According to ISO 15197 and the Food and Drug Administration Standard

Chang Hun Park; Youngjin Youn; Cheol Young Park; Min Jung Kwon

Evaluation of New Blood Glucose Monitoring System According to ISO 15197 and the Food and Drug Administration Standard

Chang Hun Park
, Youngjin Youn
, Cheol Young Park
, Min Jung Kwon

Soonchunhyang University
Samsung Changwon Hospital
Kangbuk Samsung Hospital

Research output: Contribution to journal › Article › peer-review

Abstract

Objective. Self-monitoring blood glucose levels using a blood glucose monitoring system (BGMS) helps minimize mortality and morbidity in patients with diabetes. We evaluated the accuracy of a new BGMS (CareSens S Fit [CaseSens; i-SENS Inc., Seoul, Korea]). Methods. Patients who visited the Endocrinology Department at Kangbuk Samsung Hospital between July 13, 2021, and August 18, 2021 were included. CareSens was evaluated in accordance with the International Organization for Standardization 2013 (ISO 15197:2013) and the Food and Drug Administration (FDA) standard 2020. Results. The study included 350 patients. The accuracy evaluation for CareSens, according to ISO 15197:2013 and FDA standard 2020, revealed that >99% of test results are within the allowed range. Conclusions. The CareSens performed excellently, meeting ISO 15197:2013 and FDA Standard 2020.

Original language	English
Pages (from-to)	547-552
Number of pages	6
Journal	Annals of Clinical and Laboratory Science
Volume	54
Issue number	4
State	Published - Jul 2024
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being
SDG 7 Affordable and Clean Energy
SDG 12 Responsible Consumption and Production

Keywords

accuracy
blood glucose
blood glucose monitoring system
diabetes mellitus

Cite this

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title = "Evaluation of New Blood Glucose Monitoring System According to ISO 15197 and the Food and Drug Administration Standard",

abstract = "Objective. Self-monitoring blood glucose levels using a blood glucose monitoring system (BGMS) helps minimize mortality and morbidity in patients with diabetes. We evaluated the accuracy of a new BGMS (CareSens S Fit [CaseSens; i-SENS Inc., Seoul, Korea]). Methods. Patients who visited the Endocrinology Department at Kangbuk Samsung Hospital between July 13, 2021, and August 18, 2021 were included. CareSens was evaluated in accordance with the International Organization for Standardization 2013 (ISO 15197:2013) and the Food and Drug Administration (FDA) standard 2020. Results. The study included 350 patients. The accuracy evaluation for CareSens, according to ISO 15197:2013 and FDA standard 2020, revealed that >99\% of test results are within the allowed range. Conclusions. The CareSens performed excellently, meeting ISO 15197:2013 and FDA Standard 2020.",

keywords = "accuracy, blood glucose, blood glucose monitoring system, diabetes mellitus",

author = "Park, \{Chang Hun\} and Youngjin Youn and Park, \{Cheol Young\} and Kwon, \{Min Jung\}",

note = "Publisher Copyright: {\textcopyright} 2024 by the Association of Clinical Scientists, Inc.",

year = "2024",

month = jul,

language = "English",

volume = "54",

pages = "547--552",

journal = "Annals of Clinical and Laboratory Science",

issn = "0091-7370",

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}

TY - JOUR

T1 - Evaluation of New Blood Glucose Monitoring System According to ISO 15197 and the Food and Drug Administration Standard

AU - Park, Chang Hun

AU - Youn, Youngjin

AU - Park, Cheol Young

AU - Kwon, Min Jung

PY - 2024/7

Y1 - 2024/7

N2 - Objective. Self-monitoring blood glucose levels using a blood glucose monitoring system (BGMS) helps minimize mortality and morbidity in patients with diabetes. We evaluated the accuracy of a new BGMS (CareSens S Fit [CaseSens; i-SENS Inc., Seoul, Korea]). Methods. Patients who visited the Endocrinology Department at Kangbuk Samsung Hospital between July 13, 2021, and August 18, 2021 were included. CareSens was evaluated in accordance with the International Organization for Standardization 2013 (ISO 15197:2013) and the Food and Drug Administration (FDA) standard 2020. Results. The study included 350 patients. The accuracy evaluation for CareSens, according to ISO 15197:2013 and FDA standard 2020, revealed that >99% of test results are within the allowed range. Conclusions. The CareSens performed excellently, meeting ISO 15197:2013 and FDA Standard 2020.

AB - Objective. Self-monitoring blood glucose levels using a blood glucose monitoring system (BGMS) helps minimize mortality and morbidity in patients with diabetes. We evaluated the accuracy of a new BGMS (CareSens S Fit [CaseSens; i-SENS Inc., Seoul, Korea]). Methods. Patients who visited the Endocrinology Department at Kangbuk Samsung Hospital between July 13, 2021, and August 18, 2021 were included. CareSens was evaluated in accordance with the International Organization for Standardization 2013 (ISO 15197:2013) and the Food and Drug Administration (FDA) standard 2020. Results. The study included 350 patients. The accuracy evaluation for CareSens, according to ISO 15197:2013 and FDA standard 2020, revealed that >99% of test results are within the allowed range. Conclusions. The CareSens performed excellently, meeting ISO 15197:2013 and FDA Standard 2020.

KW - accuracy

KW - blood glucose

KW - blood glucose monitoring system

KW - diabetes mellitus

UR - https://www.scopus.com/pages/publications/85204418195

M3 - Article

C2 - 39293837

AN - SCOPUS:85204418195

SN - 0091-7370

VL - 54

SP - 547

EP - 552

JO - Annals of Clinical and Laboratory Science

JF - Annals of Clinical and Laboratory Science

IS - 4

ER -

Evaluation of New Blood Glucose Monitoring System According to ISO 15197 and the Food and Drug Administration Standard

Abstract

UN SDGs

Keywords

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