Senseonics Holdings "announced the first pediatric study participant has been inserted with Eversense(R) 365-day system as part of the pivotal ENHANCE clinical trial at the AMCR Institute, a clinical research center focused on pre-diabetes, type 1, type 2 diabetes and obesity, under the direction of Dr. Timothy Bailey. The ENHANCE Trial is designed to evaluate the accuracy and safety of the Eversense system for up to 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 and the last patient is expected to complete their 365-day visit during the third quarter of 2023. Data gathered in this trial is also planned to be used to submit for the integrated continuous glucose monitoring, iCGM, designation in 2023. An investigational device exemption supplement was submitted and approved for expansion of the trial to allow for pediatric patients 14 to 18 years of age and the first pediatric study participants were enrolled in Q2 2023."
Published first on TheFly
See Insiders’ Hot Stocks on TipRanks >>
Read More on SENS:
