FDA Expands Approval of Eversense CGM System

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FDA Expands Approval of Eversense CGM System

The U.S. Food and Drug Administration (FDA) recently granted expanded approval to Eversense, a continuous glucose monitoring system that includes a tiny implantable sensor and wearable transmitter to monitor glucose for 90 days.

Available since September 2018, Eversense is newly approved with a non-adjunctive indication dosing claim, which means that users can manage their diabetes without confirmatory fingers ticks throughout the day. “With this indication when users are going to eat or take insulin, they can check their Eversense, make a treatment decision and move on with their day,” says Mike Gill, vice president and general manager at Senseonics of Germantown, Maryland. “Users will still need to calibrate twice a day or every 12 hours, but between those calibration times this new indication will save users a lot of finger sticks.”

Implantable system

The Eversense system includes three elements: an implantable sensor, a smart transmitter worn over the sensor to enable data communication, and a mobile app for displaying glucose values, trends and alerts. The product is the first one that measures glucose readings for up to 90 days with one sensor. About the size of a long headphone jack, the sensor is inserted under the skin in the upper arm by a health-care provider during an in-office visit.

In addition, the system features a silicon-based adhesive to easily apply the removable transmitter. “One big difference with the system is the adhesive that allows users to take the transmitter on and off every day and is gentle on the skin,” says David Ahn, MD, program director and Kris V. Iyer Endowed Chair in Diabetes Care at Hoag Memorial Hospital Presbyterian in Newport Beach, CA.

The water-resistant transmitter is worn on the skin over the sensor to track glucose readings and send continuous updates to the smartphone app. A new app for the non-adjunctive indication is expected to be available in Apple and Google Play stores in the fourth quarter of 2019.

The transmitter can be programmed to independently vibrate when it notices that glucose levels go outside of healthy bounds, helping patients to quickly address their condition. “The removable transmitter and on-body vibration alerts allow users to be more discreet as they manage their diabetes,” says Ahn.

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Real-world use

In a recent analysis, people using Eversense have experienced 62% time in the target range for sensor glucose values of 70–180 mg/dl during their first sensor wear. This analysis is based on real-world data from the first 205 users in the United States who completed the first 90 sensor wear days.

“We’re very encouraged that the Eversense CGM System is helping people achieve favorable outcomes in real-life, home-use settings,” says Francine Kaufman, M.D., chief medical officer at Senseonics. “These results are similar to controlled clinical trials, which demonstrate that patients who wear CGM spend more time in range, less time in hypoglycemia and are able to better manage their diabetes.”

The company recently started a new study in patients at several clinic sites across the country to test the system for 180-day duration with one calibration each day.

“Overall, we want to eliminate calibration,” says Gill, “but we also want to extend our sensor duration so there needs to be a balance to ensure the accuracy throughout the life of the sensor.”

Want to learn more about CGM? Watch “Continuous Glucose Monitoring” and read “CGM for Diabetes Management” and “Sensing the Big Picture With Continuous Glucose Monitoring.”

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