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-EGA) - were presented at a medical symposium sponsored by Abbott Laboratories prior to the 40th Annual Meeting of the European Association for the Study of Diabetes.

According to a release from Abbott, Continuous glucose monitoring is designed to provide not just a snapshot of glucose levels at one point in time, but also directional data based on analysis taking place every 60 seconds, in the case of Abbott's FreeStyle Navigator. This provides the potential to allow patients to monitor how their glucose levels are changing and potentially avoid hypoglycemic events.

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.

"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, such as rapid blood glucose descents that may lead to hypoglycemia," said Dr. Clarke, professor of paediatrics in the Department of Paediatrics, Division of Endocrinology/Diabetes at the University of Virginia Health System in Charlottesville. Dr. Clarke and Dr. Kovatchev presented the study findings in Munich.

Dr. Clarke, who presented the findings in Munich, 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.

"Continuous monitoring requires a paradigm shift in how patients and healthcare professionals think about and assess test results," said Ed Fiorentino, president of Abbott Diabetes Care, a division of Abbott Laboratories. "We believe that continuous glucose monitoring sensors, such as Navigator, have the potential to make a significant difference in the lives of people with diabetes. Education will play a key role in helping patients understand how to best take advantage of their potential," he concluded.

CG-EGA was developed by Boris Kovatchev, Linda Gonder-Frederick, Daniel Cox, and William Clarke, of 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.

Worldwide, an estimated 177 million adults (age 20 to 79 years) have diabetes. This represents approximately 5.2 per cent of the global adult population.