Dexcom, a provider of real-time continuous glucose monitoring (CGM) for diabetics, has been granted FDA Breakthrough Device Designation of its Dexcom CGM for use in the hospital setting.
Dexcom CGM uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a smart device, providing real-time glucose data without the need for fingersticks. The system also offers customizable alerts and alarms to help avoid potentially dangerous low and high blood sugar events.
“In our extensive use of Dexcom CGM in our hospitals as part of exploratory studies over the last seven years, more than 800 of those patients treated during the pandemic, we have found that the device improves glucose control without any increased risk in hypoglycemia,” says Athena Philis-Tsimikas, MD, endocrinologist and corporate vice president for the Scripps Whittier Diabetes Institute in San Diego. “Breakthrough Device Designation from the FDA could be transformative for using CGM for in-patient care in hospitals.”
The FDA’s Breakthrough Device Designation is designed to expedite the development and regulatory review of medical devices that hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or condition. Breakthrough devices benefit from interactions with the FDA’s experts to efficiently address topics in a timely way.
“During the COVID-19 pandemic, the FDA allowed Dexcom CGM to be used in hospitals to help health care providers manage patient glucose levels,” says Gil Rivas, vice president, general manager of hospital at Dexcom. “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.”