The U.S. Food and Drug Administration has granted its Premarket Approval application to market Eversense Continuous Glucose Monitoring(CGM) Systemto people with diabetes. The system is the first and only CGM system to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way,” said Tim Goodnow, President and CEO of Senseonics. “More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.”
With 70 percent of patients struggling to control blood glucose levels and with hypoglycemia prevalent among insulin users, healthcare professionals believe there are many U.S. patients who could benefit from CGM. Yet the technology is significantly underutilized among the millions of insulin-using patients who could be ideal CGM candidates.
The Eversense System addresses many of the barriers to CGM use. The system consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. The sensor, which is inserted subcutaneously in the upper arm by a physician via a brief in-office procedure, lasts up to three months, thereby eliminating the need for patients to self-administer the weekly or biweekly sensor insertions required by traditional CGM systems.
The system’s smart transmitter is light, discreet, and comfortable to wear. Interpreting glucose data from the sensor and sending it to the system’s mobile application via Bluetooth, the smart transmitter provides on-body vibratory alerts for discretion and added safety, and is the only CGM transmitter that can be removed and recharged without discarding the sensor.
The Eversense CGM System’s PMA application was based on the previously-reported results of the PRECISE II U.S. pivotal trial in which Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centers in the United States. The study clearly demonstrated the system’s safety and effectiveness over 90 days of continuous glucose sensor wear. This March, the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel of independent medical experts voted unanimously, 8 to 0, that the system not only was safe and effective, but also that its benefits outweighed the risks.
The Eversense® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is performed by a physician. The Eversense CGM System is a prescription device; patients should talk to their doctor to learn more. For important safety information, see https://eversensediabetes.com/safety-info/.
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.