Clinical and technical evaluation of a new self-monitoring blood glucose meter: assessment of analytical and user error

Our study aimed to validate (against the standards of the American Diabetes Association and the International Organization for Standardization) the an alytical and clinical accuracy of the new MediSense Precision Plus Electrod es on the QID system when compared with a reference method using the Abbott Vision glucose analyzer. Previous studies have shown that the overall accu racy of the device also depends on the proficiency of the operator, so we a lso assessed the 'case of use' of the MediSense system, by comparing the re sults obtained by the patient and health care professional. Accuracy of the self-monitored blood glucose measurements was evaluated over a wide range of glucose readings (1.6-20.0 mmol/l). Between-run CVs (using the manufactu rer's quality control material) were found to be 7% at 2.7 mmol/l and 4.8% at 15.5 mmol/l (n = 380). We used the error-grid analysis with target range blood glucose, then separated the data into different subsets, We found th at 100%: of all measurements were in the clinically acceptable zones of A a nd B. All measured values of the MediSense QID system complied with the req uirements for 'blood glucose monitoring meters', as proposed by the Interna tional Organization for Standardization. The rating of the patient question naire showed a good to very good overall rating and acceptance with a short instruction time. The results indicate that that the MediSense QID/Precisi on Plus Electrodes is a reliable and easy to use device, which can be recom mended for the majority of patients with diabetes mellitus. (C) 2001 Elsevi er Science Ireland Ltd. All rights reserved.