The Eversense CGM System sensor is implanted into the patient’s arm and sends glucose data every 5 minutes to a mobile app.
Senseonics Holding, Inc. announced today that the US Food and Drug Administration has granted its Premarket Approval (PMA) application approval, allowing the company to market the Eversense Continuous Glucose Monitoring (CGM) System to patients with diabetes in the US.
"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,” said Tim Goodnow, PhD, President and CEO of Senseonics. “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."
The FDA announced the approval, highlighting the agency’s regulatory approach to the growing arena of medical apps and software products.
"The FDA is committed to advancing novel products that leverage digital technology to improve patient care," said FDA Commissioner Scott Gottlieb, MD. "These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms.
The CGM system is the first to offer an implantable glucose sensor that can monitor blood glucose levels continuously for up to 3 months. Eversense is indicated for measuring glucose levels continually in adults age 18 and older with either type 1 or type 2 diabetes, for up to 90 days. The system is intended to supplement, not replace, blood glucose monitoring via fingerstick.
"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.
The Eversense CGM system incorporates a fluorescence-based sensor, a smart transmitter worn over the sensor to transmit data, and a mobile app for presenting glucose levels, trends, and alerts. Glucose data are automatically sent to the patient’s smartphone every 5 minutes via the mobile app.
The sensor is subcutaneously injected in the patient’s upper arm by a physician and lasts up to 3 months, unlike traditional CGM systems that require weekly or biweekly sensor insertions self-administered by patients with diabetes.
"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," said Goodnow.
The continuous glucose monitoring system’s PMA application included data from the PRECISE II study of 90 adults with type 1 or type 2 diabetes. The trial was conducted at 8 clinics in the US and demonstrated safety and efficacy over 90 days of Eversense use.
“The data shows [sic] 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," said Edelman.