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FDA Approves Eversense E3 CGM System for Use up to 6 Months
The 180-day sensor life doubles the period of continuous use and cuts in half the number of CGM removals and reinsertions, without loss of accuracy.
©waldenmarus/stock.adobe.com
The US Food and Drug Administration on February 11, 2022, approved the Eversense E3 Continuous Glucose Monitoring (CGM) System (Sensionics) which uses a proprietary sacrificial boronic acid (SBA) design modification that extends the survival of the system’s sensor from 3 months up to as long as 6 months, according to a statement from Sensionics.
The previous Eversense CGM System, approved in the US in 2018, was the first implantable CGM system approved by the FDA for marketing in the US and had a sensor life of 90 days.
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate. The next generation Eversense E3 System delivers on both,” said Satish Garg, MD, professor of medicine and director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, in a statement from Sensionics. Garg was the principal investigator of the PROMISE study results from which formed the basis for the FDA’s subsequent approval.
PROMISE was a prospective, multicenter trial assessing the accuracy and safety of the Eversense 180 CGM System in 181 participants with type 1 and type 2 diabetes. The overall mean absolute relative difference against the reference value was 9.1% for the primary sensor and 8.5% for the SBA sensor. The study also reported a confirmed hypoglycemic alert detection rate of 93% for the primary sensor and 94% for the SBA sensor. There were no unanticipated adverse events and no adverse device effects.
The 180-day wear duration translates to 2 sensor insertion and removal procedures a year, according to the statement. The removable smart transmitter provides subtle vibratory alerts to low and high blood glucose levels and transmits data to a mobile app for easy visual access to glucose values, trends, and alerts.
“Further extending the duration of the longest lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” said Tim Goodnow, PhD, president and CEO of Senseonics.
While COVID-19 priorities placed the FDA review on hold for a year, “together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to US patients beginning in the second quarter” of 2022.
The Eversense E3 CGM System is indicated for continually measuring glucose levels for up to 6 months in persons with diabetes aged ≥18 years. The sensor insertion and removal procedures are performed by a trained and certified health care provider. The Eversense CGM System is available with a physician's prescription.
