Senseonics Completes First Pediatric 365-Day CGM Implant

Senseonics recently announced the first pediatric study participant was implanted with the Eversense 365-day system, an implantable continuous glucose monitoring (CGM) system.
 
The insert was part of the pivotal ENHANCE clinical trial at the AMCR Institute, under the direction of Dr. Timothy Bailey.
 
“It is a priority for Senseonics to extend the benefits of Eversense to the pediatric patient population. Positive results in the trial would support expanding our ability to transform lives in the global diabetes community,” Francine Kaufman, M.D., chief medical officer of Senseonics told the press. “The differentiated features of our long-term implantable Eversense system are uniquely suited to benefit pediatrics and enable parents and their children to work together to manage diabetes. Young people would have the ability to remove their transmitters to participate in activities, without having to worry about wasting valuable sensors, and enjoy ring-free vibrating alarms to help manage their sugar levels without attracting unwanted attention to themselves.”
 
“I am excited to be one of the investigators in the ENHANCE Trial and thrilled to be the first to enroll subjects in the pediatric extension,” added Timothy Bailey, M.D., head of AMCR Institute in Escondido, California. “In our experience, CGM is an essential tool for all people with diabetes, especially for those who take insulin. We believe having additional accurate, and especially long-term wear, CGM options for our pediatric patients and their families will increase utilization of the technology and improve the quality of their lives.”
 
The ENHANCE trial will evaluate safety and efficacy of Eversense for up to a year. Enrollment was completed in September 2022 and the last patient is expected to finish their 365-day visit during Q3 2023.
 
Data collected in this trial is planned to be use for the integrated continuous glucose monitoring (iCGM) designation this year. An investigational device exemption (IDE) supplement was submitted and approved to expand the trial to pediatric patients aged 14 to 18. The first pediatric trial participants were enrolled in Q2 2023.
 
For more information on innovative diabetes management technologies, check out this article!