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New Tool Developed To
Evaluate The Accuracy Of Continuous Glucose Monitoring
posted September 22, 2004
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.
Source: Diabetes In Control.com:
Results Presented At Medical Symposium At Annual Meeting Of European Association
For The Study Of Diabetes Sept. 4, 2004.
September 2004
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