On April 1, 2020, the Federal Drug Administration (FDA) notified Dexcom that it is exercising its enforcement discretion and will not object to the use of continuous glucose monitoring (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. This does not expand Dexcom’s current authorized indications for use for its home use product.
Extending use of the Dexcom CGM systems to hospitalized patients during the COVID-19 emergency in order to allow hospital staff to remotely monitor glucose in patients may reduce provider/patient interaction, limiting viral exposure by hospital staff, and conserve personal protective equipment.
However, the Fact Sheet for Healthcare Providers should be reviewed carefully before using the Dexcom CGM systems in hospital settings.
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.
Watch and learn more about the value and use of CGM in the hospital.
Review evidence demonstrating the impact that CGM use can have on glucose management in hospital.
Accuracy and Glycemic Efficacy of Continuous Glucose Monitors in Critically Ill COVID-19 Patients: A Retrospective Study
Boeder S et al. J Diabetes Sci Technol. July 2022.
Use and Accuracy of Inpatient CGM During the COVID-19 Pandemic: An Observational Study of General Medicine and ICU Patients
Longo RR et al. Journal of Diabetes Science and Technology. May 2021.
Implementation of a Continuous Glucose Monitoring Program at a Safety Net Hospital During Covid 19 Pandemic
Finn EE et al. Journal of the Endocrine Society. May 2021.
Continuous Glucose Monitoring in the Operating Room and Cardiac Intensive Care Unit
Perez-Guzman MC et al. Diabetes Care. March 2021.
Continuous Glucose Monitoring in the Intensive Care Unit During the COVID-19 Pandemic
Agarwal S et al. Diabetes Care. March 2021.
Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring in Critically Ill COVID-19 Patients
Faulds ER et al. Endocrine Practice. January 2021.
Outcomes and Healthcare Provider Perceptions of Real-Time Continuous Glucose Monitoring (rtCGM) in Patients with Diabetes and COVID-19 Admitted to the ICU
Chow KW et al. Journal of Diabetes Science and Technology. January 2021.
Continuous Glucose Monitoring in Critically Ill Patients with COVID-19: Results of an Emergent Pilot Study
Sadhu AR et al. Journal of Diabetes Science and Technology. October 2020.
Continuous Glucose Monitoring–Guided Insulin Administration in Hospitalized Patients With Diabetes:A Randomized Clinical Trial
Spanakis E et al. Diabetes Care. August 2022.
Management of Hyperglycemia in Hospitalized Adult Patients in Non-Critical Care Settings: An Endocrine Society Clinical Practice Guideline
Korytkowski M et al. J Clin Endocrinol Metab. August 2022.
Practical Implementation of Remote Continuous Glucose Monitoring in Hospitalized Patients with Diabetes
Baker M et al. American Journal of Health-System Pharmacy. March 2022.
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Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients With Diabetes
Davis GM et al. Diabetes Care. June 2021.
Use and Accuracy of Inpatient CGM During the COVID-19 Pandemic: An Observational Study of General Medicine and ICU Patients
Longo RR et al. Journal of Diabetes Science and Technology. May 2021.
Reducing Inpatient Hypoglycemia in the General Wards Using RealTime Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial
Singh LG et al. Diabetes Care. November 2020.
Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting
Fortmann AL et al. Diabetes Care. November 2020.
A Pilot Study of the Feasibility and Accuracy of Inpatient Continuous Glucose Monitoring
Nair BG et al. Diabetes Care. November 2020.
Feasibility of Inpatient Continuous Glucose Monitoring During the COVID-19 Pandemic: Early Experience
Reutrakul S et al. Diabetes Care. October 2020.