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.
About Eversense
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.
About Senseonics
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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