Drug Safety Alerts

Dexcom G4 PLATINUM and Dexcom G5 Continuous Glucose Monitoring (CGM) Systems

5/04/2020

Dexcom, the manufacturer of Dexcom G4 PLATINUM and Dexcom G5 Continuous Glucose Monitoring (CGM) Systems, has announced the following anticipated changes coming this year:

• As of June 2020, they will discontinue the sale of their transmitters for the Dexcom G4 PLATINUM and Dexcom G5 CGM Systems in the United States. In addition, they cannot guarantee the continued availability of sensors for Dexcom G4 PLATINUM or Dexcom G5 CGM Systems beyond the end of this year.

• Further, as of June 30, 2020, they will no longer support the Dexcom Share 2 app and it will cease to function after this date. As such, Dexcom Follow app users currently receiving glucose data from patients on the Dexcom G4 PLATINUM system will no longer receive these updates.

• Finally, the manufacturer will also discontinue Dexcom Studio, which means the app will no longer be available for download and will no longer be supported as of December 31, 2020. In lieu of the Dexcom Studio app, all Dexcom CGM users have access to Dexcom CLAIRITY, which provides enhanced reporting and management tools. Additional information on CLARITY can be found at www.dexcom.com/clarity.

• Dexcom wants their customers to experience the latest in CGM technology and invites their customers to learn about the Dexcom G6, visit www.dexcom.com/G6.

Please speak with your patient(s) to allow for the timely transition to Dexcom’s latest CGM technology in an effort to minimize any impact to your patients’ use of CGM Systems to manage their diabetes.

CVS Caremark® Response: CVS Caremark will continue to dispense these products until current supplies are depleted at which time, patients will need a new prescription for an alternate product for insulin therapy.

For more information on this issue, health care providers may contact Dexcom at 1-888-738-3646 www.dexcom.com/clarity. You may also contact the United States Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.