
Senseonics Completes 365-Day ENHANCE Pivotal Clinical Study, Moves Closer to One-Year Eversense Implantable Sensor Approval
Senseonics Holdings, Inc., a medical technology company specializing in the development and production of long-term, implantable continuous glucose monitoring (CGM) systems for individuals with diabetes, announced a significant milestone today. The company has successfully concluded its ENHANCE Pivotal Clinical Study’s adult cohort, marking the final 365-day visit for the study’s last participant.
The ENHANCE study, a pivotal clinical trial, was designed to assess the accuracy and safety of Senseonics’ Eversense system for an entire year. Over 165 adult subjects received Eversense CGM systems at four different centers across the United States. The enrollment for the 365-day sensor configuration was finalized in September 2022. Data collected during this extensive study also played a crucial role in supporting the FDA submission for the integrated continuous glucose monitoring (iCGM) designation, which was achieved earlier in 2023.
The study’s primary efficacy endpoint is to measure the mean absolute relative difference (MARD) for the Eversense system compared to reference measurements through 365 days post-insertion. The study will also has a primary safety endpoint to evaluate the incidence of device-related or sensor insertion/removal procedure-related serious adverse events.
Senseonics intends to utilize the data gathered from the ENHANCE study to further advance its mission of offering a differentiated CGM solution that can operate for a full year using a single sensor. If successful, this endeavor will provide individuals with diabetes an alternative option for longer-term and more effective diabetes management.
Senseonics uses an implantable sensor versus patch-based sensors utilized by other CGM devices. In 2022 the company received FDA approval to extend the timeframe for their sensor from 90 to 180 days requiring two implants per year. This is substantially longer than competitive devices. DexCom’s G6 sensor can currently be used for 10 days. Medtronic’s Enlite sensor can be used for 6 days and their Guardian sensor can be used for 7 days. Abbott’s FreeStyle Libre sensor can be used for up to 14 days.
“We are pleased that all patients have completed the testing for the adult arm of the ENHANCE clinical study. 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,” commented Dr. Francine Kaufman, Chief Medical Officer of Senseonics. “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. We appreciate the efforts of the participating investigators and patients and look forward to analyzing the data, preparing the submission and working with the FDA with the goal to secure approval for the planned 365-day Eversense® system in the coming quarters.”
Additionally, Senseonics recently received approval for an investigational device exemption (IDE) supplement to expand the ENHANCE study to include pediatric patients aged 14 to 18. The current trial only enrolled patients over 18 years of age. The first participants in this pediatric cohort were enrolled in the second quarter of 2023.