GERMANTOWN, MD--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, will present the long-term safety data of the Eversense CGM System derived from its Post Market Clinical Follow Up (PMCF) registry in Europe. The poster is to be presented by Katherine Tweden, PhD on Saturday, June 8 from 11:30 am – 12:30 pm in Hall F of the North Exhibition building during the annual American Diabetes Association Scientific Sessions held in San Francisco.
“We are pleased with the results of the European Eversense PMCF registry which demonstrate the safety of the Eversense CGM System in a large group of patients,” said Katherine Tweden, PhD, Vice President of Clinical Sciences at Senseonics. “This post-market study was an opportunity to evaluate the real-world experience of Eversense and Eversense XL CGM as patients wore their first, second, third and fourth sensors. The results, with 3,667 patient-years of wear, demonstrated a strong safety profile over repeat sensor cycles for the first long-term implantable sensor.”
Eversense CGM is the first implantable, long-term continuous glucose monitoring system available to people with diabetes. Past clinical studies evaluated the safety of the system using a study design of one insertion and removal cycle. The purpose of the prospective PMCF registry was to establish the long-term safety of the Eversense CGM System after repeated insertions in real-world home-use settings. Safety data from 3,066 Eversense users from 15 European countries was collected and reported. Repeat insertions of the Eversense CGM confirmed the safety profile of prior studies and showed it to be safe for long-term continuous use.
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 that can be removed, recharged and re-adhered without discarding the sensor. The sensor is inserted subcutaneously in the upper arm by a health care provider during a brief in-office procedure.
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 in the US and the Eversense XL CGM System is indicated for up to 180 days outside of the US. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is 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, visit https://www.eversensediabetes.com/safety-info/ for Eversense or https://ous.eversensediabetes.com/safety-info/ for Eversense XL.
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.