Senseonics Announces the First Pediatric Study Participant Insertions in the ENHANCE Clinical Trial
April 18 2023 - 4:15PM
Business Wire
Senseonics Holdings, Inc. (NYSE-American: SENS), a medical
technology company focused on the development and manufacturing of
long-term, implantable continuous glucose monitoring (CGM) systems
for people with diabetes, today announced the first pediatric study
participant has been inserted with Eversense® 365-day system as
part of the pivotal ENHANCE clinical trial at the AMCR Institute, a
clinical research center focused on pre-diabetes, type 1, type 2
diabetes and obesity, under the direction of Dr. Timothy
Bailey.
“It is a priority for Senseonics to extend the benefits of
Eversense to the pediatric patient population. Positive results in
the trial would support expanding our ability to transform lives in
the global diabetes community,” said Francine Kaufman, M.D., Chief
Medical Officer of Senseonics. “The differentiated features of our
long-term implantable Eversense system are uniquely suited to
benefit pediatrics and enable parents and their children to work
together to manage diabetes. Young people would have the ability to
remove their transmitters to participate in activities, without
having to worry about wasting valuable sensors, and enjoy ring-free
vibrating alarms to help manage their sugar levels without
attracting unwanted attention to themselves.”
“I am excited to be one of the investigators in the ENHANCE
Trial and thrilled to be the first to enroll subjects in the
pediatric extension,” said Timothy Bailey, M.D., head of AMCR
Institute in Escondido, California. “In our experience, CGM is an
essential tool for all people with diabetes, especially for those
who take insulin. We believe having additional accurate, and
especially long-term wear, CGM options for our pediatric patients
and their families will increase utilization of the technology and
improve the quality of their lives.”
The ENHANCE Trial is designed to evaluate the accuracy and
safety of the Eversense system for up to one year. Over 165 adult
subjects were inserted with Eversense systems in four centers
across the United States. Enrollment for the 365-day sensor
configuration was completed in September 2022 and the last patient
is expected to complete their 365-day visit during the third
quarter of 2023. Data gathered in this trial is also planned to be
used to submit for the integrated continuous glucose monitoring,
iCGM, designation in 2023. An investigational device exemption
(“IDE”) supplement was submitted and approved for expansion of the
trial to allow for pediatric patients 14 to 18 years of age and the
first pediatric study participants were enrolled in Q2 2023.
About Senseonics
Senseonics Holdings, Inc. (“Senseonics”) is a medical technology
company focused on the development and manufacturing of glucose
monitoring products designed to transform lives in the global
diabetes community with differentiated, long-term implantable
glucose management technology. Senseonics' CGM systems, Eversense®,
Eversense® XL and Eversense® E3 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.
About Eversense
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels in persons age
18 years and older with diabetes for up to 6 months. 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 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 trained and certified 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://www.ascensiadiabetes.com/eversense/safety-info/.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements about
expanding the benefits of Eversense to additional populations,
statements regarding patient perceptions of the benefits of
Eversense, statements regarding user adoption of Eversense,
statements regarding advancing development programs, statements
regarding regulatory submissions, and other statements containing
the words “believe,” “expect,” “intend,” “may,” “projects,” “will,”
“planned,” and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: uncertainties inherent in the
commercial launch of Eversense® E3 CGM system and commercial
expansion of the Eversense product, uncertainties inherent in the
transition of commercialization responsibilities to Ascensia
Diabetes Care and its commercial initiatives, uncertainties
inherent in collaborating with a new partner in the Nurse
Practitioner Group and that partner’s assumption of certain
clinical and administrative activities, uncertainties in insurer,
regulatory and administrative processes and decisions,
uncertainties in the duration and severity of the COVID-19
pandemic, uncertainties inherent in the development and
registration of new technology, uncertainties relating to the
current economic environment, and such other factors as are set
forth in the risk factors detailed in Senseonics’ Annual Report on
Form 10-K for the year ended December 31, 2022 and Senseonics’
other filings with the SEC under the heading “Risk Factors.” In
addition, the forward-looking statements included in this press
release represent Senseonics’ views as of the date hereof.
Senseonics anticipates that subsequent events and developments will
cause Senseonics’ views to change. However, while Senseonics may
elect to update these forward-looking statements at some point in
the future, Senseonics specifically disclaims any obligation to do
so except as required by law. These forward-looking statements
should not be relied upon as representing Senseonics’ views as of
any date subsequent to the date hereof.
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INVESTOR CONTACT Philip Taylor Gilmartin Group
415-937-5406 investors@senseonics.com
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