The US Food and Drug Administration has approved new software for the Dexcom continuous glucose meter (CGM) that improves its accuracy to a level approaching that of finger-stick glucose measurement.
Software 505 will be provided free of charge to adult patients who are already using the Dexcom G4 Platinum. "The combination of the new software with the CGM advantages of real-time trends, speed, and direction provide a complete picture of the patient's glucose activity," according to a Dexcom statement.
With the new algorithm, the mean absolute relative difference (MARD) — the percentage of data points above or below a laboratory reference standard for blood glucose — drops from the current 13% down to 9%.
"This is the first CGM being commercialized with a sub-10% MARD. That's a big deal," Steve Pacelli, Dexcom's executive vice president of strategy and corporate development, told Medscape Medical News.
The new software therefore brings the CGM's accuracy closer to the 5.6% MARD found for finger-stick blood glucose monitoring. Nonetheless, as with other CGM devices, the Dexcom system is still not approved for making treatment decisions. Patients are still advised to use results from finger-stick glucose testing to calculate insulin doses.
The company is currently working with the FDA to determine what type of clinical trial would be needed to enable that restriction to be removed from the labeling, Mr Pacelli told Medscape Medical News.
Medscape Medical News © 2014 WebMD, LLC
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Cite this: New Continuous Glucose Monitor Software Improves Accuracy - Medscape - Nov 12, 2014.