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"Accuracy of the 5-day FreeStyle Navigator® Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements"

¹Diablo Clinical Research, 2255 Ygnacio Valley Road, Suite M, Walnut Creek, CA 94598

rweinstein{at}diabloclinical.com

ABSTRACT

OBJECTIVE:: To assess the accuracy of the FreeStyle Navigator® Continuous Glucose Monitoring System measurements of glucose in interstitial fluid in comparison with Yellow Springs Instrument (YSI) laboratory reference measurements of venous blood glucose.

RESEARCH DESIGN AND METHODS:: Fifty-eight subjects with type 1 diabetes, ages 18 to 64 years, were enrolled in a multi-center, prospective, single-arm study. Each subject wore two sensors simultaneously which were calibrated with capillary fingerstick measurements at 10, 12, 24, and 72 hours after insertion. Measurements from the FreeStyle Navigator system were collected at one-minute intervals and compared with venous measurements taken once every 15 minutes for 50 hours over the five-day sensor wear in an in-patient clinical research center. Periods of high rates of change of glucose were induced by insulin and glucose challenges.

RESULTS:: Comparison of the FreeStyle Navigator measurements with the laboratory reference method (n=20,362) gave mean and median absolute relative differences (ARD) of 12.8% and 9.3% respectively. The percentage in the clinically-accurate Clarke error grid A zone was 81.7% and 16.7% in the benign error B zone. During low rates of change (less than ±1 mg/dL/min), the percentage in the A zone was higher (84.9%) and the mean and median ARD were lower (11.7% and 8.5%, respectively).

CONCLUSIONS:: The FreeStyle Navigator system was found to be consistent and accurate compared with venous measurements made using a laboratory reference method over five days of sensor wear (82.5% in the A zone on day one, 80.9% on day five).

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