FDA Approves New 6-month Continuous Glucose Monitoring System

Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense® E3 Continuous Glucose Monitoring (CGM) System. Ascensia plans to make the Eversense E3 sensor, which can be used for up to 6 months, available to patients in the U.S. during the second quarter of 2022.          

Robert Schumm, President at Ascensia Diabetes Care, said, “As the world’s first and only long-term CGM System, Eversense is truly innovative and the prospect of using a single sensor for 6 months is a huge step forward for people with diabetes. Ensuring that as many people as possible have access to Eversense E3 is key for us and we’ll be introducing a program to help users experience Eversense affordably as we work closely with payers on coverage. We look forward to rolling out this next-generation system through our dedicated CGM commercial team in the U.S. in the coming months, as we strive to improve the lives of people with diabetes everywhere.”

Developed by Senseonics and brought to people with diabetes by Ascensia, the newly approved Eversense E3 CGM System, which includes a sacrificial boronic acid (SBA) design modification to enhance sensor survival, offers patients:

•             The longest lasting CGM available, with 6-month sensor wear duration and essentially two sensor insertion and removal procedures per year

•             Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% demonstrated in the PROMISE Study1 for the duration of sensor wear

•             A fully implantable fluorescence-based sensor, with a removable smart transmitter* that provides discreet on-body vibratory alerts and transmits data to a mobile app

•             Fewer calibrations, with primarily one calibration required per day after day 21 of use

“This next generation system delivers on the patient’s desire for a CGM sensor that is both long-lasting and highly accurate,” said Elaine Anderson, Head of Eversense CGM Business Unit at Ascensia Diabetes Care. “Its unique features and benefits offer people with diabetes unparalleled flexibility, convenience and accuracy. Our partner Senseonics has designed Eversense E3 with the user in mind and we are excited to bring the system to people in the U.S. in the second quarter.”