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.
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.
Bagsic S et al. Journal of Diabetes Science and Technology. April 2023.
Continuous Glucose Monitoring for Patients with COVID-19 Pneumonia: Initial Experience at a Tertiary Care Center
Dumitrascu A et al. Endocrine Practice. March 2023.
Dumitrascu A et al. Endocrine Practice. March 2023.
2022
Continuous Glucos e Monitoring–Guided Insulin Administration in Hospitalized Patients With Diabetes: A Randomized Clinical Trial
Spanakis E et al. Diabetes Care. October 2022.
Spanakis E et al. Diabetes Care. October 2022.
Real-Time Continuous Glucose Monitoring in the Hospital Identifies and Prompts Treatment for Hypoglycemia
Baker M et al. ADA Abstract. June 2022.
Baker M et al. ADA Abstract. June 2022.
Management of Hyperglycemia in Hospitalized Adult Patients in Non-Critical Care Settings: An Endocrine Society Clinical Practice Guideline
Korytkowski M et al. The Journal of Clinical Endocrinology & Metabolism. June 2022.
Korytkowski M et al. The Journal of Clinical Endocrinology & Metabolism. June 2022.
Use of a Continuous Glucose Monitoring System in High-Risk Hospitalized Noncritically Ill Patients With Diabetes After Cardiac Surgery and During Their Transition of Care From the Intensive Care Unit During COVID-19: A Pilot Study
Sweeney A et al. Endocrine Practice. March 2022.
Sweeney A et al. Endocrine Practice. March 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.
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.
Baker M et al. American Journal of Health-System Pharmacy. November 2021.
Comparison of Dexcom G6 Continuous Glucose Monitoring and Point-of-Care Blood Glucose Testing in Hospitalized Patients with Diabetes
Davis G et al. ADA Abstract. June 2021.
Davis G et al. ADA Abstract. June 2021.
Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Diabetes
Davis G et al. Diabetes Care. June 2021.
Davis G et al. Diabetes Care. June 2021.
2020
Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting
Fortmann A et al. Diabetes Care. August 2020.
Fortmann A et al. Diabetes Care. August 2020.
Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial
Singh G et al. Diabetes Care. August 2020.
Singh G et al. Diabetes Care. August 2020.
Real-Time CGM in Intensive Care Units
2023
A Calibration Protocol for Continuous Glucose Monitor Accuracy in the ICU
Bann S et al. ADA Abstract. June 2023.
Bann S et al. ADA Abstract. June 2023.
Hybrid Continuous Glucose Monitoring Protocols in the Intensive Care Unit Multicenter Experience
Faulds E et al. ADA Abstract. June 2023.
Faulds E et al. ADA Abstract. June 2023.
Glycemic Monitoring Using the Dexcom G6 in Cardiac Surgery
Insler S et al. ADA Abstract. June 2023.
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.
Faulds E et al. Journal of Diabetes Science and Technology. April 2023.
2022
Accuracy and Glycemic Efficacy of Continuous Glucose Monitors in Critically Ill COVID-19 Patients: A Retrospective Study
Boeder S et al. Journal of Diabetes Science and Technology. July 2022.
Boeder S et al. Journal of Diabetes Science and Technology. July 2022.
Nursing Perspectives on Hospital Use of Dexcom Continuous Glucose Monitor in Patients with Suspected or Known COVID-19 during Insulin Infusion
Pattison J et al. ADA Abstract. Jun 2022.
Pattison J et al. ADA Abstract. Jun 2022.
2021
Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study
Faulds E et al. The Journal of Clinical Endocrinology & Metabolism. June 2021.
Faulds E et al. The Journal of Clinical Endocrinology & Metabolism. June 2021.
Use and Accuracy of Inpatient CGM During the COVID-19 Pandemic: An Observational Study of General Medicine and ICU Patients
Longo R et al. Journal of Diabetes Science and Technology. May 2021.
Longo R et al. Journal of Diabetes Science and Technology. May 2021.
Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill COVID-19 Patients
Faulds E et al. Endocrine Practice. January 2021.
Faulds E et al. Endocrine Practice. January 2021.
2020
Use of Continuous Glucose Monitoring to Assess Parenteral Nutrition–Induced Hyperglycemia in an Adult Patient With Severe COVID-19
Chow K et al. Journal of Parenteral and Enteral Nutrition. October 2020.
Chow K et al. Journal of Parenteral and Enteral Nutrition. October 2020.
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