Dexcom Continuous Glucose Monitoring (CGM) Systems are indicated for home use and have not been FDA-cleared or approved for use in hospital settings. FDA notified Dexcom on April 1, 2020, however, that it will not object to Dexcom’s provision of CGM systems for the treatment of patients in hospital settings and other healthcare facilities to support COVID-19 healthcare-related efforts during the current pandemic.
Due to the public health crisis of COVID-19 and the need to preserve personal protective equipment (PPE) and reduce frequency of staff exposure, Dexcom is making its Dexcom G6 CGM Systems (Dexcom G6) available for remote patient monitoring in the hospital setting.
This document is meant to inform healthcare professionals of the specific considerations for use of the Dexcom G6 in hospitals and other healthcare facilities to support COVID-19 healthcare related efforts. The following information should be reviewed carefully by healthcare professionals before using Dexcom G6 in hospital settings.
The Dexcom G6 system is a real-time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older for in-home use. For complete indication for use and intended use statements, please see Dexcom G6 Instructions for Use.1
Contact Dexcom Medical Science Team at [email protected] with questions.
Report Adverse events, including problems with performance or results, to Dexcom by calling: 1-844-607-8398 and selecting option for healthcare professional support or submit web support request at dexcom.com/contact/hospitals (same day follow up).
Adverse events, including problems with test performance or results, can be reported to MedWatch by submitting the online FDA Form 3500 at accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or by calling 1-800-FDA-1088.
CDC webpages:
General: cdc.gov/COVID19
Healthcare Professionals: cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Infection Prevention and Control Recommendations in Healthcare Settings: cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
Infection Control: cdc.gov/coronavirus/2019-ncov/infection-control/index.html
FDA webpage:
General: fda.gov/novelcoronavirus
1 Dexcom G6 CGM System User Guide
2 Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may falsely elevate G6 readings.