Abstract
Blood glucose monitoring systems (BGMS) are essential for the management of diabetic patients. Although International Organization for Standardization (ISO) 15197:2015 criteria require rigorous monitoring of BGMS devices before commercialization, manufacturing quality standards may decline after FDA or EU approval. This work aimed to demonstrate the accuracy and precision of two BGMS devices currently available on the market. A laboratory study was conducted from June to August 2021 using two BGMS devices. One hundred samples were collected and evaluated according to ISO 15197:2015 guidelines. Over 95% accuracy was achieved by both devices using stricter ISO criteria (at least 95% of values within ±10 mg/dL or ±10% of the results of the reference measurement procedure). Analysis of the error grid showed that 99.5% of the results were in zone A. Surveillance of the accuracy and precision of BGMS devices after FDA and EU approval is an essential procedure to help patients and physicians manage glycemia and determine an appropriate outcome and personalized approach to diabetes treatment.
Highlights
Blood Glucose Monitoring Systems (BGMS) are essential for controlling blood glucose (BG) in patients with diabetes because they help patients, their clinicians, and caregivers in the daily management of the disease to monitor diabetes therapy and maintain glycemic targets [1]
Accuracy of BGMS According to International Organization for Standardization (ISO) 15197:2015 Guidelines Minimum accuracy requirements were fulfilled by both tested BGMS (Device 1: 98.5%; Device 2: 99.5%)
More stringent criteria was not achieved by both tested BGMS: 67% of samples were within the reference range
Summary
Blood Glucose Monitoring Systems (BGMS) are essential for controlling blood glucose (BG) in patients with diabetes because they help patients, their clinicians, and caregivers in the daily management of the disease to monitor diabetes therapy and maintain glycemic targets [1]. Monitoring patients’ blood glucose helps clinicians prevent potential and dangerous metabolic conditions, such as hypoglycemia or hyperglycemia, facilitates their work, and promotes optimal insulin management, especially in patients with intensive insulin therapy or insulin pumps [2,3,4,5]. The International Organization for Standardization’s (ISO) standard 15197:2013, first published in 2003 and revised in 2013 with the introduction of more stringent criteria (harmonization EN ISO 15197:2015), defines the accuracy and precision requirements necessary for the BGMS [7]. Inaccurate BGMS measures could be potentially life-threatening and with relevant economic repercussions [9]
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