Issue: April 2022
Perspective from Archana R. Sadhu, MD, FACE
Source:

Press release

Disclosures: Rivas is the vice president and general manager of hospital at Dexcom. Philis-Tsimikas reports advisory board fees paid to her institution by Dexcom.
March 02, 2022
1 min read
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CGM granted breakthrough device designation for in-hospital use

Issue: April 2022
Perspective from Archana R. Sadhu, MD, FACE
Source:

Press release

Disclosures: Rivas is the vice president and general manager of hospital at Dexcom. Philis-Tsimikas reports advisory board fees paid to her institution by Dexcom.
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The FDA has granted breakthrough device designation for the use of Dexcom’s continuous glucose monitoring system in the hospital setting, according to an industry press release.

The breakthrough device designation comes nearly 2 years after the FDA notified Dexcom it would exercise enforcement discretion and permit the use of its CGM system in treating patients in hospital settings and other health care facilities to support COVID-19-related efforts during the pandemic.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock

“During the COVID-19 pandemic, the FDA allowed Dexcom CGM to be used in hospitals to help health care providers manage patient glucose levels,” Gil Rivas, vice president and general manager of hospital at Dexcom, said in a press release. “What started as a response during the pandemic has shown promise as a better alternative to finger stick blood glucose tests with greater quality of care and patient satisfaction.”

Dexcom’s CGM uses a small, wearable sensor and transmitter to continuously measure and send glucose level to a smart device, providing real-time glucose data. The system has customizable alerts and alarms for low and high blood glucose events.

The FDA’s breakthrough device designation expedites the development and regulatory review of medical devices with the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Manufacturers of breakthrough devices interact with the FDA to address topics in a timely way.

“In our extensive use of Dexcom CGM in our hospitals as part of exploratory studies over the last 7 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,” Athena Philis-Tsimikas, MD, an 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.”