New Tool Developed To Evaluate The Accuracy Of Continuous Glucose Monitoring

Continuous glucose sensor technology has the potential to revolutionize diabetes management by providing patients with ongoing, online feedback about current blood glucose levels and rate/direction of change, as well as alarms to alert for possible dangerous trends. A new analytical tool created to evaluate the clinical accuracy of continuous glucose monitoring in people with diabetes shows that continuous monitoring can provide highly accurate test results. Findings from a paper published about the tool – called Continuous Glucose Error-Grid Analysis (CG-EGACG–EGA was developed by Boris Kovatchev, Ph.D., Linda Gonder-Frederick, Ph.D., Daniel Cox, Ph.D., and William Clarke, M.D., Profesor of Pediatrics at the University of Virginia Health System. This group previously developed the Clarke Error-Grid Analysis, the current standard for evaluating the clinical accuracy of fingerstick blood glucose monitoring.

CG–EGA takes into account not just static point accuracy of glucose levels, but also directional accuracy, which tells patients whether their glucose levels are rising, falling or remaining steady.

Dr. Clarke, cautioned that evaluation of continuous glucose sensor accuracy is not straightforward, "especially if taken in the context of established accuracy measures." He compared current fingerstick testing to still camera photography and likened continuous monitoring to an advancement akin to video technology. "Thus, it would be inappropriate to gauge the accuracy of still cameras and camcorders using the same static measure," he added.

Dr. Clarke and his collaborators illustrated the applicability of CG–EGA using data collected during a clinical trial of Abbott Laboratories’ Freestyle Navigator™ System, an investigational device designed to continuously monitor interstitial glucose levels. Abbott Laboratories plans to submit an application for CE Marking for use of Freestyle Navigator in Europe in 2005. The system is under review by the Food and Drug Administration in the United States.

Dr. Clarke added, "Compared to a few self-monitoring blood glucose readings per day, the FreeStyle Navigator yielded detailed, directional results on a minute-by-minute basis."

Continuous monitoring will require a paradigm shift in how patients and healthcare professionals think about and assess test results.

Results Presented At Medical Symposium At Annual Meeting Of European Association For The Study Of Diabetes Sept. 4, 2004.

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