GERMANTOWN, Md.--(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.