New Continuous Glucose Monitor Software Improves Accuracy

Miriam E Tucker

November 12, 2014

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.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....