First-of-its-Kind Implantable CGM Approved by FDA

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First-of-its-Kind Implantable CGM Approved by FDA

(Image courtesy of Senseonics)

The makers of a device new to the U.S. market hope it will help people with diabetes better manage their disease. Using first-of-its-kind technology, the Eversense Continuous Glucose Monitoring (CGM) System’s sensor can be implanted in the arm for up to three months.

Already available in Europe for the past two years, the Senseonics device was approved by the U.S. Food and Drug Administration (FDA) on June 21 for use in people age 18 and older. The device is a three-part system: a fluorescence-based sensor that is implanted into the upper arm at a doctor’s office, a transmitter worn over it to communicate data, and a mobile app that shows glucose levels, trends, and alerts.

The user’s glucose readings are automatically sent to the app every five minutes, and it can warn that levels are headed to a high or low. The sensor even transmits on-body alerts through vibrations, regardless of whether the user’s mobile phone is nearby.

Other currently available CGMs require self-administered changes of the sensor roughly every 6–10 days, while the Eversense remains viable for three months, at which point a physician can remove the device and implant a new one in the patient’s other arm.

“Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia,” said Dr. Steven Edelman, a professor of medicine at University of California San Diego, as well as the Founder & Director of Taking Control of Your Diabetes, and a Senseonics board member. “Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring.

Only an estimated 25 percent of people with Type 1 diabetes use CGMs, and Edelman explains this may be due to “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.”

The first generation of CGMs were introduced roughly two decades ago, and initial error margins were in the double digits. The Eversense CGM boasts of a significantly lower margin of 8.5, and aims to eliminate other barriers as well, including difficulty of self-administering, discomfort, bruising, indiscreet appearance, and short-term use.

This CGM does not eliminate the need for daily fingersticks, which help ensure accuracy, but it can help eliminate unhealthy glucose highs and lows throughout the day.

“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,” said Tim Goodnow, president and CEO of Senseonics. “More importantly, 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.”

Want to learn more about managing glucose levels with CGM? Read “Sensing the Big Picture With Continuous Glucose Monitoring.”

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