Effect of Acetaminophen on the Accuracy of Glucose Measurements Obtained with the GlucoWatch Biographer

Abstract

Background: Improved glycemic control significantly reduces long-term microvascular complications of diabetes mellitus associated with chronic hyperglycemia. The GlucoWatch® biographer is designed to facilitate intensive diabetes management by providing automatic, frequent, and noninvasive glucose readings up to three times per hour for as long as 12 hours. Methods: The device extracts glucose through intact skin using reverse iontophoresis and measures the extracted glucose with an electrochemical biosensor. A clinical trial was performed to assess the effect of acetaminophen, a potential interference for traditional blood glucose meters, on the accuracy of the GlucoWatch biographer in adult subjects with diabetes (n= 18). One thousand milligram doses of acetaminophen were administered to subjects in two groups: one to achieve C_max (peak acetominophen concentration) at the time of biographer calibration and the other to achieve C_max during the measurement period. The biographer readings were compared to serial fingerstick blood glucose measurements. Results: Time profiles over 9 hours show close tracking of the biographer glucose results with fingerstick blood glucose measurements for all groups. The mean difference between the two measurements is between 8 and 12 mg/dL for all groups. The mean absolute value of the relative difference is less than 20%, and more than 93% of the points were in the clinically acceptable (A + B) region of the Clarke Error Grid. No statistically significant differences were found for any accuracy measurement across all groups. Conclusions: The GlucoWatch Biographer provides frequent measurements of glucose over a 12-hour period with high accuracy. No effect of therapeutic dosage of acetaminophen on the accuracy of the glucose readings was found.