FDA extends use of implantable CGM sensor to 6 months
The FDA has approved extending the use of an implantable continuous glucose monitoring sensor for up to 6 months for adults with diabetes, according to a company press release.
Senseonics’s Eversense E3 continuous glucose monitoring system is a fully implantable third-generation sensor that connects to a removable smart transmitter and mobile app displaying glucose values, trends and alerts. As Healio previously reported, the system received FDA approval in 2018 for use up to 90 days. The FDA also previously granted a nonadjunctive indication for the system in 2019 to allow patients to use the device as a replacement for finger sticks.
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center of the University of Colorado, and the principal investigator of the pivotal PROMISE Study, in a press release. “The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last 6 months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”
In findings from the PROMISE study published in Diabetes Technology & Therapeutics, the modified sensor using sacrificial boronic acid technology had 93.9% of CGM readings fall within 20% of the reference range of glucose analyzer values, with an overall mean absolute relative difference of 8.5%. The confirmed alert detection rate was 94% at 70 mg/dL and 99% at 180 mg/dL, and 90% of the sensors were still being used at the end of the 180-day trial period, according to researchers.
Senseonics is planning to make the Eversense E3 available in the U.S. through its global commercial partner Ascensia Diabetes Care beginning in the second quarter of 2022.
“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,” Tim Goodnow, PhD, president and CEO of Senseonics said in a press release. “The review was delayed by one year due to COVID-19 priorities and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to U.S. patients beginning in the second quarter.”
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