CGM granted breakthrough device designation for in-hospital use
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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.
“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.”
Perspective
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In April 2020, the FDA took the first step in the advancement of inpatient continuous glucose monitoring use by issuing an allowance of noninvasive remote monitoring devices to support patient monitoring during the COVID-19 pandemic. Due to the unique restraints the pandemic placed on our patients and our health care workers to deliver safe, yet effective care, this allowance spurred the immediate use of inpatient CGM by some investigators and clinicians in hospital systems. Historically, clinical trials using CGM technology in hospitalized patients failed to meet accuracy standards when compared with YSI values and improve clinical outcomes to achieve FDA approval for hospital use. However, these trials were not performed with current models of improved sensor technology. Because of the gravity and immediate necessity that the pandemic created, we gained further “real world” experience with CGM in the inpatient setting. From this pandemic as well as prior clinical experience, Dexcom submitted data from more than 800 patients and demonstrated adequate safety to obtain this breakthrough device designation from the FDA on March 1, 2022, almost 2 years after the initial allowance.
While further clinical trials are ongoing to establish traditional endpoints of accuracy, safety and clinical outcomes, this breakthrough designation is a milestone that will expedite the development and review of these trials by the FDA. This will certainly catapult CGM integration into routine inpatient glucose management, a much needed tool in hospital medicine.
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