Senseonics Launches Eversense CGM System with Non-Adjunctive Claim in the U.S.
Users of the only long-term implantable CGM system can now manage their diabetes treatment decisions without a fingerstick confirmation
GERMANTOWN, Md.–(BUSINESS WIRE)–Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced today that Eversense users who download the new Eversense® CGM mobile app can start dosing insulin based off of the readings from their Eversense System without the need to do a confirmatory blood glucose fingerstick measurement.
“We’re very pleased that today, the new Eversense app is available from the Apple App and Google Play stores, so now users in the United States can take full advantage of being able to make treatment decisions without the need to test their blood glucose levels. It’s a testament to the proven and robust Eversense technology that only a year after entering the U.S. market, we can enhance the user experience by providing this updated indication,” said Tim Goodnow, PhD, President and Chief Executive Officer at Senseonics. “And with Eversense designated as a therapeutic CGM and payment decision from the Centers of Medicare and Medicaid was made, Medicare beneficiaries will soon be able to use Eversense CGM as part of their diabetes treatment plan in 2020.”
The Eversense CGM System 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. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and can be removed, recharged and re-attached to the skin without discarding the sensor. The sensor is inserted subcutaneously in the upper arm by a health care provider via a brief in-office procedure. With the non-adjunctive claim, the Eversense CGM System will still require 2 calibrations a day.
“Patients have expressed that many of the unique features of Eversense – its long-term use, removeable transmitter, predictive alerts, and on-body vibratory alerts – allow them to be more discreet with their diabetes treatment,” explained Francine R. Kaufman, MD, Endocrinologist, Chief Medical Officer and Board member at Senseonics “Now, Eversense users also have the added benefit of not having to interrupt their activities to fingerstick before taking insulin, eating or exercising. They can simply look down at their Eversense app and move on with their treatment decisions – providing them more flexibility throughout the day.”
Patients who are interested in getting started on Eversense, now with fewer fingersticks, can sign up at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners or physician assistants interested in offering the Eversense CGM System for their patients can contact 844-SENSE4U (844-736-7348).
The Eversense® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration twice per day, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://eversensediabetes.com/safety-info/.
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.
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