根据 ISO 15197 和食品药品管理局标准评估新型血糖监测系统。

IF 1.1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Annals of clinical and laboratory science Pub Date : 2024-07-01

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

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引用次数: 0

摘要

目的：使用血糖监测系统（BGMS）自我监测血糖水平有助于最大限度地降低糖尿病患者的死亡率和发病率。我们评估了新型血糖监测系统（CareSens S Fit [CaseSens; i-SENS Inc：方法：纳入 2021 年 7 月 13 日至 2021 年 8 月 18 日期间在江北三星医院内分泌科就诊的患者。CareSens 根据国际标准化组织 2013 (ISO 15197:2013) 和美国食品和药物管理局 (FDA) 2020 标准进行评估：研究共纳入 350 名患者。根据 ISO 15197:2013 和 FDA 2020 标准对 CareSens 的准确性进行评估后发现，99% 以上的检测结果都在允许范围内：CareSens表现优异，符合ISO 15197:2013和FDA 2020标准。

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

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.

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来源期刊

Annals of clinical and laboratory science 医学-医学实验技术

CiteScore

1.60

自引率

0.00%

发文量

112

审稿时长

6-12 weeks

期刊介绍： The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.