Information for Healthcare Providers:
Dexcom G7 CGM System in the Hospital
Dexcom Continuous Glucose Monitoring (CGM) Systems are indicated for home use and have not been FDA-cleared or approved for use in hospital settings. However, the US Food and Drug Administration (FDA) originally notified Dexcom on April 1, 2020 that it will not object to Dexcom’s provision of CGM systems for the treatment of patients in hospital settings and other healthcare facilities during the public health emergency. Dexcom received communication from the FDA stating FDA does not intend to object to Dexcom's continued distribution of CGM systems to hospitals after the end of the public health emergency transition period (November 7, 2023), until FDA makes a final decision on Dexcom’s marketing submission for the Hospital CGM System. This does not expand Dexcom’s current authorized indications for use for its home use product.
This information is meant to inform healthcare professionals of the specific considerations for use of Dexcom G7 CGM Systems in hospitals and other healthcare facilities. This information should be reviewed carefully by healthcare professionals before using Dexcom CGM systems in hospital settings.
FDA Grants Breakthrough Device Designation for Dexcom Hospital CGM System
Dexcom CGM for use in the hospital setting was granted FDA Breakthrough Device Designation. The Breakthrough Device program is designed to expedite the development and regulatory review of medical devices that hold the potential for more effective treatment of life-threatening or irreversibly debilitating disease or condition.
This does not expand Dexcom’s current authorized indications for use of its home use product.
Dexcom G7 in the hospital setting
Watch and learn more about the value and use of CGM in the hospital
Overview of Dexcom G7
Clinical Use of CGM
Clinical Evidence
Review evidence demonstrating the impact that CGM use can have on glucose management in hospital. These publications are provided by the Dexcom Medical Science team to educate healthcare professionals on the use of Dexcom CGM systems in the hospital under FDA enforcement discretion or clinical trial.
Real-Time CGM in Non-Intensive Care Units
Publications
Real-Time CGM in Intensive Care Units
Publications
Information Request for Healthcare Providers