FDA’s Advisory Committee meeting just voted to recommend approval of the expansion of the Dexcom G5 CGM label. Thank you DPAC (Diabetes Patient Advocacy Coalition)!

DPAC

 

The results are in and the FDA panel has voted the following for the labeling change of the Dexcom G5 Continuous Glucose Monitoring System:

  1. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is safe for the proposed indications of use?  YES: 8 NO: 2
  2. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is effective for the proposed indications for use? YES: 9 NO: 1
  3. Do the benefits of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications of use outweigh the risks of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications for use. YES: 8 NO: 2

Thanks to everyone who shared support with FDA through the DPAC petition or other means. Patients’ voices are an important consideration in decision-making and we have shown with this success that we are being heard. This is just a quick thanks for being part of the good news.

Please remember that this is just an FDA Advisory Panel which sends recommendations to the FDA for a final ruling. But it is a great step in the right direction! Next, maybe Medicare will remove the caution of CGM being simply “precautionary”, and thereby affording Medicare coverage for CGM.

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