FDA approves Eversense CGM system for use for up to six months

The FDA has approved Senseonics’ Eversense E3 CGM System, which includes proprietary sacrificial boronic acid (SBA) technology to extent longevity to six months. The system is planned to become available to patients in the US through Ascensia Diabetes Care. Senseonics’ global commercial partner.

The Eversense E3 CGM System offers patients:

• Fully implantable third generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.
• Industry leading 6 month sensor wear duration, making Eversense the longest lasting CGM system available, with essentially two sensor insertion and removal procedures per year.
• Removable smart transmitter, held in place with a mild silicone-based adhesive, providing discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.

The system is indicated for continually measuring glucose levels, for up to six months in persons with diabetes age 18 and older. It is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration, and when symptoms do not match CGM information, or when taking medications of the tetracycline class.

“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, 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 PROMISE Study1, which formed the basis for the FDA approval. “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.”

Lina Adams