A COMPREHENSIVE EVALUATION OF A BLOOD-GLUCOSE SELF-MONITORING SYSTEM FOR DIABETES CARE

Systems for diabetic patients to use in self-monitoring of blood gluco se (SMBG) range widely in coefficient of variation (CV) and are subjec t to user error. The Glucometer Elite Diabetes Care System is a credit card-sized blood glucose meter that uses a unique design based on ele ctrochemical biosensor technology. An assessment of its accuracy and p recision, as well as of how patient training affected its use, was con ducted. In the accuracy portion of the study, evaluating 54 blood samp les, there was a high correlation between values obtained from the Glu cometer Elite and those derived from a laboratory standard (r = .998). All samples were clinically accurate by Error Grid analysis. The prec ision of the Glucometer Elite system was evaluated by calculating the mean CV of each of three meters in four blood glucose ranges (50 to 10 0 mg/dL, 101 to 150 mg/dL, 151 to 300 mg/dL, and 301 to 500 mg/dL) and by performing an analysis of variance (ANOVA) on data sets for each b lood glucose range. ANOVA revealed no statistically significant differ ences between meters (P < 0.05). Patients who did and did not receive instruction were similar in their ability to use the Glucometer Elite system correctly. Patients who had a history of performing SMBG ranked the Glucometer Elite system superior to their previously used blood g lucose meters in several categories. The Glucometer Elite system is ac curate, precise, and easy for patients to learn to use. Additionally, it has high patient acceptance.