Abbott announced the presentation of results from a new study designed to assess the accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System for people with diabetes. The study met its primary endpoint of demonstrated accuracy and stability over five days of wear.
Study results were discussed by William L. Clarke, M.D., professor of paediatrics at the University of Virginia Health System, in a presentation during the 66th annual Scientific Sessions of the American Diabetes Association.
FreeStyle Navigator Continuous Glucose Monitoring System is an investigational device under FDA review. The system includes a five-day sensor, a transmitter, and a wireless receiver with a built-in FreeStyle blood glucose monitoring system. The system is designed to provide glucose readings once per minute, high/low glucose alarms and projected glucose alarms.
The accuracy of FreeStyle Navigator was assessed in 58 subjects ranging in age from 18 to 64. Comparison of the FreeStyle Navigator system measurements (n=20,362) with a laboratory reference method (YSI) gave a mean absolute relative difference of 12.8 per cent and a median absolute relative difference of 9.3 per cent. On the Clarke Error Grid (CEG), 81.7 percent (n=16627) of measurements were in zone A, and 16.7 per cent (n=3398) were in zone B (as compared to YSI). The Clarke Error Grid compares readings from a lab reference to a reading from a glucose monitoring device at a specific point in time. The variance between the two readings is placed on a grid within clinical categories, also known as zones. Each zone is labelled A, B, C, D, or E. Points in the A zone are clinically accurate and most consistent with the lab reference value. B zone readings are clinically acceptable. Points in the C, D, and E zones are progressively less accurate.
"Frequent and accurate glucose monitoring is an essential element of achieving tight glycemic control. The accuracy, particularly in the A zone, of continuous glucose monitoring sensors is critical to assessing the benefits that patients can derive from the technology," said Dr. Clarke. "In clinical studies presented by Abbott earlier this week, the FreeStyle Navigator system, under development, has set a new threshold for point glucose accuracy in a continuous glucose monitoring system."
"We look forward to making FreeStyle Navigator available to people with diabetes and we're very pleased that the system continues to demonstrate excellent accuracy in clinical studies," said Ed Fiorentino, president, Abbott Diabetes Care.