麻豆传媒

The FDA approved the long-term implantable continuous glucose monitor (CGM) for use for up to 6 months, .

The Eversense E3 System is indicated for adults ages 18 and older with type 1 or type 2 diabetes. Implanted subcutaneously into the upper arm under local anesthesia, the system allows for replacement of finger stick blood glucose measures. The only time fingersticks are still required with this system is for calibration, when symptoms don't match the CGM readings, or if the user is taking a tetracycline class medication.

This approval allows for double the wear time, as the system was initially approved for 90-day use in June 2018.

"We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate," said Satish Garg, MD, of the University of Colorado in Aurora, in a statement. "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."

The system features proprietary sacrificial boronic acid (SBA) technology that allows for sensor accuracy up to 180 days by reducing oxidation of the glucose-binding indicator chemistry.

Working with the implanted sensor, the removable transmitter is held in place via a silicone-based adhesive that delivers on-body vibratory alerts and data transmission to a mobile app where data on glucose values, trends, and alerts are monitored every 5 minutes.

"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," noted Garg, who served as the principal investigator of the PROMISE study, which the approval was based on.

In PROMISE, which was presented at the 2021 virtual American Diabetes Association (ADA) Scientific Sessions, the Eversense E3 CGM System demonstrated a mean absolute relative difference (MARD) of 8.5% between clinic reference values and the device's primary sensor based on almost 50,000 paired CGM points. When testing CGMs, smaller MARDs indicate more accurate sensors. Generally, anything less than 10% is considered very good. The sensor was most accurate when measuring euglycemic ranges, with the highest MARD reported with hypoglycemic ranges. But all MARDs remained below 10% for all blood glucose ranges.

During this study, 90% of the SBA sensors lasted the entire 180-day wear; 96% of SBA sensors survived to day 90 and day 120, and 94% survived to day 150.

"Clearly, this biochemical change that has been made in the SBA sensor is probably the future way to go," Garg said during the ADA meeting. "The majority of the patients can have 6 months of data available to them with one particular implant."

Senseonics said the Eversense E3 CGM System is expected to be available to U.S. patients beginning in the second quarter of this year.

Comment