Senseonics Holdings, Inc. announced the completion of the ENHANCE Pivotal Clinical Study adult cohort following the recently completed 365-day visit for the final study patient. The ENHANCE study is designed to evaluate the accuracy and safety of the Eversense system for one year. Over 165 adult subjects were inserted with Eversense systems in four centers across the United States.

Enrollment for the 365-day sensor configuration was completed in September 2022. Data gathered in this study was also used to support the FDA submission for the integrated continuous glucose monitoring, iCGM, designation earlier in 2023. An investigational device exemption supplement was submitted and approved for expansion of the study to allow for pediatric patients 14 to 18 years of age and the first pediatric study participants were enrolled in second quarter 2023.