Senseonics
Senseonics has announced the FDA has approved its PMA application to market the Eversense Continuous Glucose Monitoring (CGM) System to people with diabetes in the United States. The system is the first and only CGM system to feature an implantable glucose sensor. Also, it provides long-term continuous monitoring for up to three months.
“We’re very pleased to receive this FDA approval. It allows us to make Eversense available in the U.S., as it is in many European markets. This product exemplifies the natural evolution for diabetes devices. Senseonics is excited to help lead the way,” said Tim Goodnow, President and CEO of Senseonics.
“More importantly, we believe the features Eversense offers will help open up CGM to millions of people with diabetes.”
The benefits of CGM
About 70% of patients struggle to control blood glucose levels and with hypoglycemia prevalent among insulin users. Thus, 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.
“Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia,” said Steven Edelman, MD, Professor of Medicine at University of California San Diego, Founder & 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. These include 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 the help of a fluorescence-based sensor
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 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.
Therefore, 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. Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centers in the U.S.
Finally, the study clearly demonstrated the system’s safety and effectiveness over 90 days of continuous glucose sensor wear. Furthermore, the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel of independent medical experts voted unanimously that the system not only was safe and effective, but also that its benefits outweighed the risks.
