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.
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