Accuracy of Two CE-Marked Blood Glucose Monitoring System Based on EN ISO 15197:2015
نویسندگان
چکیده
Blood glucose monitoring systems (BGMS) are essential for the management of diabetic patients. Although International Organization Standardization (ISO) 15197:2015 criteria require rigorous BGMS devices before commercialization, manufacturing quality standards may decline after FDA or EU approval. This work aimed to demonstrate accuracy and precision two currently available on market. A laboratory study was conducted from June August 2021 using devices. One hundred samples were collected evaluated according ISO guidelines. Over 95% achieved by both stricter (at least values within ±10 mg/dL ±10% results reference measurement procedure). Analysis error grid showed that 99.5% in zone A. Surveillance approval is an procedure help patients physicians manage glycemia determine appropriate outcome personalized approach diabetes treatment.
منابع مشابه
System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197.
BACKGROUND Blood glucose (BG) monitoring systems enable diabetes patients to effectively control and adjust their therapy. BG monitoring systems with a Conformité Européenne (CE) label should meet the standard DIN EN ISO 15197:2003: > or =95% of the BG results shall fall within +/-15 mg/dL of the reference method at BG concentrations <75 mg/dL and within +/-20% at BG concentrations > or =75 mg/...
متن کاملSystem accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197.
BACKGROUND The accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions. METHODS This system accuracy evaluation study was performed according to DIN EN ISO 15197:2003 for 43 Conformité Européenne (CE)-labeled blood glucose (BG) monitoring systems. Measurement results of each system were compared with r...
متن کاملSystem accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards.
Corresponding Author: Guido Freckmann, M.D., Institut für Diabetes-Technologie Forschungsund Entwicklungsgesellschaft mbH, Helmholtzstrasse 20, 89081 Ulm, Germany; email address [email protected] In a letter to the editor, Teodorczyk and coauthors1 comment on our data2 published in Journal of Diabetes Science and Technology. In studies2 conducted at the Institut für Diabetes-Technologi...
متن کاملAccuracy of Four Blood Glucose Monitoring Systems
Method: Accuracy of the four blood glucose monitoring systems for fingertip capillary blood testing was assessed at three diabetes clinics. A total of 142 diabetic subjects were included in the study. At each study site, the trained operator tested the subject’s fingertip blood with the four systems and a YSI glucose analyzer, which served as the reference. Accuracy was evaluated according to I...
متن کاملAccuracy of Four Blood Glucose Monitoring Systems
Background: The minimum acceptable accuracy for results produced by a blood glucose monitoring system according to the current version of ISO 15197, created in 2003, is: 95% of the individual glucose results shall fall within ±15 mg/dL (0.83 mmol/L) of the results of the manufacturer’s measurement procedure at glucose concentrations < 75 mg/dL (< 4.2 mmol/L) and within ±20% at glucose concentra...
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ژورنال
عنوان ژورنال: Diabetology
سال: 2021
ISSN: ['2673-4540']
DOI: https://doi.org/10.3390/diabetology2040021