Dexcom (NSDQ:DXCM) announced that it received FDA breakthrough device designation for the use of its CGM in a hospital setting.
The FDA early in the COVID-19 pandemic issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance included continuous glucose monitors.
“What started as a response during the pandemic has shown promise as a better alternative to fingerstick blood glucose tests with greater quality of care and patient satisfaction,” Dexcom VP and GM of Hospitals Gil Rivas said in a news release.
Dexcom CEO Kevin Sayer has said in the past that he sees hospital settings as an additional market for CGMs.
The Dexcom continuous glucose monitor uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a smart device to provide real-time glucose data and eliminate the need for fingersticks. It also offers customizable alerts and alarms to make the patient aware of blood sugar levels and potentially avoid dangerous low and high blood sugar events.
Scripps Whittier Diabetes Institute Corporate VP Dr. Athena Philis-Tsimikas said that San Diego-based Dexcom’s CGM has been used in hospitals as part of exploratory studies over the last seven years.
In those exploratory studies, with more than 800 patients involved treated during the COVID-19 pandemic, Philis-Tsimikas said the device was found to have improved glucose control without any increased risk of hypoglycemia. She called breakthrough designation potentially “transformative for using CGM for in-patient care in hospitals.”
