JDRF Applauds FDA CGM Decision

in , ,

JDRF applauds the FDA decision today to approve a new indication for use for the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. The Dexcom G5® CGM is now indicated to replace fingerstick blood glucose testing for diabetes management decisions.

JDRF’s Chief Mission Officer, Dr. Aaron Kowalski, was among many in the diabetes community who spoke in favor of this new indication for use at the FDA Clinical Chemistry and Clinical Toxicology Devices Advisory Panel meeting held to discuss this proposal on July 21, 2016. Overall, CGM devices provide better glucose control and lower rates of severe hypoglycemia. With this decision, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use CGM as a replacement for their blood glucose meters and make management decisions based on the interstitial fluid glucose concentration reported by the device. JDRF is pleased that the approved indication for use for the Dexcom G5® CGM has now been expanded giving people with type 1 diabetes (T1D) even more treatment options.

This FDA approval also removes one of the obstacles that has been cited by Medicare as a reason a CGM couldn’t be considered for coverage. JDRF strongly supports Medicare coverage for CGM devices, which are recommended by national diabetes clinical guidelines and covered by nearly all private health plans, and has been engaging both the executive branch and Congress to advance coverage of these important technologies.

By Nate Rutledge