Long-term, fully implantable CGM garners FDA approval
The first continuous glucose monitoring system with a fully implantable sensor and compatible mobile app is now FDA approved for use in adults with diabetes.
The Eversense Continuous Glucose Monitor (Senseonics) 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, according to a company press release.
The small, subcutaneous sensor is implanted in the upper arm by a health care provider during an outpatient procedure, and then measures glucose levels for up to 90 days. The sensor utilizes light-based technology to measure glucose levels and send information to the app to alert users of hypoglycemia and hyperglycemia. Measurements are sent every 5 minutes to a compatible mobile device via the app, according to an FDA release. The smart transmitter provides on-body vibratory alerts for discretion and safety. This is the only CGM transmitter that can be removed and recharged without discarding the sensor, according to the company.
The new CGM system addresses many barriers to CGM use.
“Despite [the benefits of CGM], a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data show 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,” Steven Edelman, MD, professor of medicine at University of California, San Diego; founder and director of Taking Control of Your Diabetes; and Endocrine Today Editorial Board member, stated in the company release.
Approval of the Eversense GCM was based on clinical trial data that demonstrated safety and efficacy of the CGM over 90 days. As previously reported by Endocrine Today, an FDA advisory panel unanimously in March recommended approval of the Eversense CGM, noting that the benefits of the CGM system outweigh the risks for adults with diabetes. Safety will continue to be assessed in a postapproval study.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” FDA Commissioner Scott Gottlieb, MD, stated in the agency release. “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 FDA is creating a new and more carefully tailored regulatory approach for software products, including mobile medical apps, that will enable efficient oversight of these digital technologies and maintain FDA’s gold standard for product review. We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities.”
Disclosures: Gottlieb is the FDA Commissioner. Edelman is a Senseonics board member.