[Current portable blood sugar analysis equipment--comparison of the MediSense Card, Glucometer Elite, Hypocount Supreme and Omnican Control with the glucose oxidase reference method].
Patients as well as medical personnel are increasingly confronted with new devices for blood glucose measurement. Devices smaller in size, faster in action and easier to handle are being developed by various companies. We investigated whether precision and accuracy of recently marketed blood glucose meters would be efficient and safe enough for clinical use, and compared the meters MediSense Card, Glucometer Elite, Hypocount Supreme, and Omnican Control with our reference glucose oxidase method. On average 200 pairs of blood glucose values from capillary blood samples of type 1 and 2 diabetic patients were determined using two meters of each make. The measurements were performed by one experienced technician using blood from the same sample for the meter and the Beckman Analyzer 2. For evaluation a linear regression analysis, the percentage of values within a maximum deviation of less than 10% from the reference value, and clinically relevant models such as Clarke's error-grid analysis and Koschinsky's acceptance analysis were used. Combining all analyses, MediSense Card and Glucometer Elite showed the least deviations in all blood glucose ranges. For MediSense Card 56%, for Glucometer Elite 72%, but for Hypocount Supreme and Omnican Control less than 50% of all values were within a +/- 10% range compared with the reference method. Clarke's error-grid analysis reflected the best results for MediSense Card and Glucometer Elite with 96% and 97% respectively of all measurements within the ideal error-grid zone A, whereas this was the case for Hypocount Supreme in 85% and for Omnican Control in only 71%. The coefficient of variance for measurements in series using 3 different blood glucose ranges was acceptable for all devices besides the Hypocount Supreme, but overall performance was poor compared to our reference method. Nevertheless, according to Koschinsky's clinical acceptance scale even Hypocount Supreme and Omnican Control can be classified as clinically acceptable (range 2 from a three point scale). The 1994 criteria of the American Diabetes Association, a maximum deviation of less than 5% in 100% of measurements, were not met by any device, but after training and with proper handling all devices work efficiently enough and are safe for clinical use. Nevertheless, companies are urged to seek new technologies for blood glucose measurement, as all recently developed devices tested in our study did not perform better than known older glucose meters.
Weitgasser
R
R
II. Medizinische Abteilung, Landeskrankenanstalten Salzburg, Osterreich.
Gappmayer
B
B
D000704:Analysis of Variance; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D006801:Humans; D016014:Linear Models; D012016:Reference Values; D015203:Reproducibility of Results