Sign up for the QMED & MD+DI Daily newsletter.
Senseonics Eyes Longer-Term CGM Sensor
The company received FDA approval to have a subgroup of PROMISE study participants continue for a total of one year to gather feasibility data on the safety and accuracy of a 365-day Eversense sensor.
February 26, 2020
3 Min Read
Image by Tumisu on Pixabay
Senseonics had all the right ingredients to pull in strong earnings in 2019. The continuous glucose monitoring (CGM) specialist had a strong product on the market and significant reimbursements – yet the company fell short of expectations.
Now Senseonics is coming into 2020 with all guns firing. The Germantown, MD-based company is making headway in developing a longer-term CGM sensor. FDA gave Senseonics the greenlight to have a subgroup of the PROMISE study participants to continue for a total of one year to gather feasibility data on the safety and accuracy of the 365-day Eversense sensor.
In a release, Mukul Jain, PhD, COO at Senseonics said, “Extending this study is really a critical step in developing a 365-day product. Information gathered from this cohort will allow us to characterize the improved sensor design and optimize our glucose algorithm for the extended, 365-day use period. This addition is an exciting extension phase of the PROMISE study and we look forward to evaluating the first multi-clinic investigation of a one-year implantable glucose sensor.”
The overall goal of the PROMISE Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over 180 days for the PMA submission to FDA. One hundred and eighty-one study participants at eight sites across the U.S. had the Eversense CGM System inserted subcutaneously as part of the study, which is completing the 180-day duration in March.
The Eversense Continuous Glucose Monitoring (CGM) System is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. The company said that fingerstick BG measurements are still required for calibration twice per day, 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 healthcare provider.
Senseonics won a nod from FDA for a version of Eversense that could maintain glucose monitoring for three months in 2018. At the time of FDA approval, Eversense had been on the market in Europe for a little more than two years. It was believed the Eversense CGM would impact DexCom’s position in the CGM market. San Diego, CA-based DexCom’s shares had already been rocked a bit by the approval of Abbott’s Freestyle Libre Flash glucose monitoring system.
But as time has shown – DexCom has soared in earnings and Senseonics had a challenging 2019. Senseonics recently made a strong display at the 2020 International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). Kyle Rose, an analyst with Canaccord Genuity, commented on the company’s impact at the conference.
“At ATTD we saw multiple posters regarding long-term wear characteristics (patients with repeat sensors) as well as real-world data from US patients that showed encouraging utilization rates and glycemic results in adult patients,” Rose wrote in research notes. “On the upcoming 4Q20 results call, we look for an update on the timing for the 180-day US approval/launch as well as the impact of recent reimbursement wins from Cigna.”
About the Author(s)
You May Also Like
Sustainable Manufacturing Expo Hits North AmericaFeb 22, 2024|4 Min Read
Medtronic Doubles Down on Sustainability EffortsFeb 22, 2024|1 Min Read
Top Medical Device M&AFeb 21, 2024|1 Min Read
FDA Urges Independent Verification of Third-Party Testing DataFeb 21, 2024|2 Min Read