Senseonics has finally received approval from the U.S. Food and Drug Administration for its Eversense E3 Continuous Glucose Monitoring System (CGM) System.
Continuous glucose monitoring system.
In concert with partner Senseonics Holdings, Ascensia Diabetes Care announced Tuesday that the U.S. Food and Drug Administration has signed off on the Eversense E3 Continuous Glucose Monitoring System (CGM) System. The device can be used for up to six months, and Ascensia plans to make it available to patients in the U.S. during the second quarter of 2022.
The Eversense E3 Continuous Glucose Monitoring System is the world’s first long-term implantable CGM system that offers exceptional accuracy for six months. The device is fully implantable just under the skin with proprietary sacrificial boronic acid technology that helps to enhance the longevity of the fluorescence-based sensor. Blood sugar in the body produces a small amount of light measured by the sensor, which sends the information to a smart transmitter. Every five minutes, measurements are sent to the device-specific mobile app, which can display trends and send alerts to the user through their device to signal high or low glucose levels. The sensor also provides discreet on-body vibratory alerts and requires fewer calibrations.
“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.”
The continuous glucose monitoring device boasts that accuracy is unaffected when taking acetaminophen and vitamin C, detects 95% of hypoglycemic and 99% of hyperglycemic events, and is shown to significantly reduce A1c, a measurement for blood sugar, by 0.5%. The CGM system remains accurate during exercise and if the sensor is slept on. The mobile app offers the ability to track meals and workouts and transfer personal data between friends, family, and healthcare providers.
The Eversense CGM System was first approved by the FDA in 2018 for use in people 18 years of age and older with diabetes. At the time, the fully implantable sensor was approved to be worn for 90 days. Approval for the six-month use of the device has been long-awaited, with delays from the COVID-19 pandemic causing setbacks as the agency allocated resources to review products related to the treatment and prevention of COVID-19.
Next for the continuous glucose monitoring (CGM) System is a 365-day pivotal trial pending investigational device exemption from the FDA.
“The Eversense E3 CGM System is an exciting advancement in diabetes management,” said Francine Kaufman, M.D., chief medical officer of Senseonics about the continuous glucose monitoring system. “We believe patients and providers are waiting for this step forward. I want to take this opportunity to thank the PROMISE Study investigators, study participants, and the Senseonics team for helping us reach this important milestone and the diligence of the FDA reviewers in this difficult environment. We are excited to begin making this next-generation product available in the U.S. to people with diabetes.”
