Senseonics (Germantown, MD) has received U.S. FDA premarket approval (PMA) to market the company's Eversense continuous glucose monitoring (CGM) system to people with diabetes in the United States. The system features an implantable glucose sensor and provides long-term continuous monitoring for up to three months.
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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.
"Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia," says Steven Edelman, MD, professor of medicine at University of California San Diego, founder and director of Taking Control of Your Diabetes, and Senseonics Board member. "Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who've tried traditional CGM in the past either don't wear it as often as they should or don't stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it's important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user."
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 can be removed and recharged without discarding the sensor.
The 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 U.S. The study clearly demonstrated the system's safety and effectiveness over 90 days of continuous glucose sensor wear.
For more information, please visit www.senseonics.com.