Senseonics Holdings, Inc. Announces Data From the Eversense® Post Approval Study to Be Presented at the 17th International Conference on Advanced Technologies and Treatments for Diabetes
08 Marzo 2024 - 2:05PM
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 data from the Eversense®
Post Approval Study is to be presented at the 17th International
Conference on Advanced Technologies and Treatments for Diabetes
(“ATTD”) in Florence, Italy.
Dr. Kashif Latif, Principal Investigator, Medical Director, and
practicing physician in Endocrinology from AM Diabetes &
Endocrinology in Bartlett, TN, is scheduled to give an oral
presentation on People Reported Outcomes (“PROs”) from the U.S.
Eversense Post Approval Study on Saturday, March 09, 2024 at 11:30
CET at Fortezza da Basso, Hall D.
“This study is the first real-world evaluation of how people
using Eversense feel about their diabetes and how Eversense helps
them manage their condition over two years of repeated sensor
insertions and removals. We are pleased the data shows high
satisfaction scores, improved diabetes distress scores, and no
evidence that repeated insertions and removals impact
satisfaction,” said Francine Kaufman, M.D., Chief Medical Officer
of Senseonics. “As patients and providers consider the best options
to help manage diabetes, presenting this additional compelling data
continues to raise the awareness of the benefits of Eversense. We
look forward to sharing the results with our colleagues at
ATTD.”
The Post Approval Study was a prospective, multicenter 2-year
evaluation of Eversense CGM System use in adults 18 years of age
and older with either type 1 or 2 diabetes (T1D or T2D).
Participants were initially inserted with the 90-day Eversense CGM
System and then transitioned to the 180-day Eversense E3 CGM System
after approval in 2022, in accordance with labeling at the time
over their 2 years of study participation. The DDS-17 (a
questionnaire designed to measure four critical dimensions of
distress with diabetes: emotional burden, regimen distress,
interpersonal distress and physician distress) was administered to
participants at the start of the study. Both the DDS-17 and CGM-Sat
(a 44-item questionnaire designed to measure the impact of using
CGM on diabetes management and family relationships regarding
satisfaction with emotional, behavioral and cognitive effects of
CGM use) were administered at 6 months, 1 year and 2 years by
design. In the study, 273 study participants with a mean age of 57,
80% of whom were people with T1D, were enrolled between March of
2019 and February of 2022 across 16 clinical sites in the United
States.
About Eversense
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels for up to 180
days in persons with diabetes age 18 and older. 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 primarily one time
a day after day 21, 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 E3 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/.
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 system Eversense® E3
includes 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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Senseonics Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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