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

Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 8508335 Publication Model: Print Cited Medium: Print ISSN: 0168-8227 (Print) Linking ISSN: 01688227 NLM ISO Abbreviation: Diabetes Res Clin Pract Subsets: MEDLINE

Publication: 1993- : Limerick : Elsevier Scientific Publishers
Original Publication: Amsterdam : Elsevier Science Publishers B.V., c1985-

Blood Glucose/*analysis ; Blood Glucose Self-Monitoring/*instrumentation ; Blood Glucose Self-Monitoring/*standards ; Diabetes Mellitus, Type 1/*blood ; Diabetes Mellitus, Type 2/*blood; Adult ; Aged ; Female ; Humans ; International Agencies ; Male ; Middle Aged ; Regression Analysis ; Reproducibility of Results ; Societies, Medical ; Switzerland ; United States

Our study aimed to validate (against the standards of the American Diabetes Association and the International Organization for Standardization) the analytical and clinical accuracy of the new MediSense Precision Plus Electrodes on the QID system when compared with a reference method using the Abbott Vision glucose analyzer. Previous studies have shown that the overall accuracy of the device also depends on the proficiency of the operator, so we also assessed the 'ease of use' of the MediSense system, by comparing the results 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 (2.6-20.0 mmol/l). Between-run CVs (using the manufacturer'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 that 100% of all measurements were in the clinically acceptable zones of A and B. All measured values of the MediSense QID system complied with the requirements for 'blood glucose monitoring meters', as proposed by the International Organization for Standardization. The rating of the patient questionnaire showed a good to very good overall rating and acceptance with a short instruction time. The results indicate that that the MediSense QID/Precision Plus Electrodes is a reliable and easy to use device, which can be recommended for the majority of patients with diabetes mellitus.

0 (Blood Glucose)

Date Created: 20010614 Date Completed: 20010823 Latest Revision: 20190910

20231215

10.1016/s0168-8227(01)00248-0

11403861