Hospital person holding tablet

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.
  • Fact sheet for providers
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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.
  • View the press release

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

2023
Real-Time Continuous Glucose Monitoring in the Hospital: A Real-World Experience
Bagsic S et al. Journal of Diabetes Science and Technology. April 2023.
2022
Management of Individuals With Diabetes at High Risk for Hypoglycemia: An Endocrine Society Clinical Practice Guideline
McCall A et al. The Journal of Clinical Endocrinology & Metabolism. December 2022.
2021
Practical Implementation of Remote Continuous Glucose Monitoring in Hospitalized Patients with Diabetes
Baker M et al. American Journal of Health-System Pharmacy. November 2021.
2020

Real-Time CGM in Intensive Care Units

2023
Glycemic Monitoring Using the Dexcom G6 in Cardiac Surgery
Insler S et al. ADA Abstract. June 2023.
Nursing Perspectives on the Use of Continuous Glucose Monitoring in the Intensive Care Unit
Faulds E et al. Journal of Diabetes Science and Technology. April 2023.
2022
2021
2020
Resource
Information Request for Healthcare Providers
Reach out to the Dexcom Medical Science team with questions regarding hospital use.
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