Evaluation of electronic, digital blood glucose monitors.

Maintenance of a normoglycemic blood glucose concentration is commonly suggested as a major goal for the control of the pathogenesis associated with diabetes mellitus. This maintenance requires accurate, reliable self-blood glucose monitoring (SBGM). Six SBGM instruments intended for home use were evaluated in this study for accuracy, precision, and human factor characteristics. Each monitor was tested on samples of blood that had glucose concentrations of 74 mg/dL, 185 mg/dL, and 294 mg/dL. Accuracy was defined as blood glucose concentration measurements within 15% of the reference value of a control blood glucose sample. Individual measurements within this range averaged 83% to 16%. The inter- and intraobserver reliabilities/precisions varied greatly among monitors. The interobserver variations, in general, were greater than the intraobserver variations. A critical factor in SBGM accuracy and reliability was the highly variable user-device interaction. So long as the user-sensitive design found in these SBGM systems is used, the accuracy and reliability of SBGM will be variable.