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 151972013) and the Food and Drug Administration (FDA) standard 2020. RESULTS: The study included 350 patients. The accuracy evaluation for CareSens, according to ISO 151972013 and FDA standard 2020, revealed that >99% of test results are within the allowed range. CONCLUSIONS: The CareSens performed excellently, meeting ISO 151972013 and FDA Standard 2020.