Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM.
Germantown, Maryland-based Senseonics’ ENHANCE study recorded the completed 365-day visit for the final study patient. The study evaluates the year-long implantable continuous glucose monitor in adults. It also has a pediatric cohort (ages 14 to 18), which saw its first patient insertion in April.
ENHANCE evaluates the safety and accuracy of Eversense over one year. More than 165 adult subjects received Eversense insertions across four U.S. centers. The company completed enrollment in September 2022. Senseonics also used data from the study to support its FDA submission for integrated continuous glucose monitoring (iCGM) designation this year.
The company’s Eversense E3, a 180-day implantable CGM, received FDA approval in February 2022. Data reported in June included evidence supporting even longer wear time, plus more positive results for the existing platform.
Senseonics Chief Medical Officer Dr. Francine Kaufman says the company aims to secure approval for the 365-day CGM “in the coming quarters.” Kaufman spoke to Drug Delivery Business News last year to lay out Senseonics’ plans for its CGM technology.
“We are pleased that all patients have completed the testing for the adult arm of the ENHANCE clinical study,” Kaufman said in a news release. “Demonstration of safe and accurate performance of Eversense for 365 days in this study would further validate its ability to facilitate more effective and longer-term management of diabetes. This represents a major milestone for Senseonics as we work towards offering the differentiated benefits of implantable CGM for one full year with just a single sensor.”