Performance of a new test strip for freestyle blood glucose monitoring systems.

BACKGROUND: a new strip, designed to enhance the ease of use and minimize interference of non-glucose sugars, has been developed to replace the current FreeStyle (Abbott Diabetes Care, Alameda, CA) blood glucose test strip. We evaluated the performance of this new strip. METHODS: laboratory evaluation included precision, linearity, dynamic range, effects of operating temperature, humidity, altitude, hematocrit, interferents, and blood reapplication. System accuracy, lay user performance, and ease of use for finger capillary blood testing and accuracy for venous blood testing were evaluated at clinics. Lay users also compared the speed and ease of use between the new strip and the current FreeStyle strip. RESULTS: for glucose concentrations <75 mg/dL, 73%, 100%, and 100% of the individual capillary blood glucose results obtained by lay users fell within ± 5, 10, and 15 mg/dL, respectively, of the reference. For glucose concentrations ≥75 mg/dL, 68%, 95%, 99%, and 99% of the lay user results fell within ± 5%, 10%, 15%, and 20%, respectively, of the reference. Comparable accuracy was obtained in the venous blood study. Lay users found the new test strip easy to use and faster and easier to use than the current FreeStyle strip. The new strip maintained accuracy under various challenging conditions, including high concentrations of various interferents, sample reapplication up to 60 s, and extremes in hematocrit, altitude, and operating temperature and humidity. CONCLUSIONS: our results demonstrated excellent accuracy of the new FreeStyle test strip and validated the improvements in minimizing interference and enhancing ease of use.

Continuous glucose monitoring in subcutaneous tissue using factory-calibrated sensors: a pilot study.

BACKGROUND: Commercial continuous subcutaneous glucose monitors require in vivo calibration using capillary blood glucose tests. Feasibility of factory calibration, i.e., sensor batch characterization in vitro with no further need for in vivo calibration, requires a predictable and stable in vivo sensor sensitivity and limited inter- and intra-subject variation of the ratio of interstitial to blood glucose concentration. METHODS: Twelve volunteers wore two FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) continuous glucose monitoring systems for 5 days in parallel for two consecutive sensor wears (four sensors per subject, 48 sensors total). Sensors from a prototype sensor lot with a low variability in glucose sensitivity were used for the study. Median sensor sensitivity values based on capillary blood glucose were calculated per sensor and compared for inter- and intra-subject variation. Mean absolute relative difference (MARD) calculation and error grid analysis were performed using a single calibration factor for all sensors to simulate factory calibration and compared to standard fingerstick calibration. RESULTS: Sensor sensitivity variation in vitro was 4.6%, which increased to 8.3% in vivo (P < 0.0001). Analysis of variance revealed no significant inter-subject differences in sensor sensitivity (P = 0.134). Applying a single universal calibration factor retrospectively to all sensors resulted in a MARD of 10.4% and 88.1% of values in Clarke Error Grid Zone A, compared to a MARD of 10.9% and 86% of values in Error Grid Zone A for fingerstick calibration. CONCLUSIONS: Factory calibration of sensors for continuous subcutaneous glucose monitoring is feasible with similar accuracy to standard fingerstick calibration. Additional data are required to confirm this result in subjects with diabetes.