“This is the first study to examine any CGM system in a pediatric population for a period of continuous wear for more than 14 days,” said Dr. Ronnie Aronson, M.D., FRCPC, FACE, primary investigator, endocrinologist and chief medical officer of LMC Diabetes & Endocrinology in Toronto, Canada. “The Eversense System was observed to be a safe and durable alternative to currently available CGM systems and demonstrated excellent accuracy. The sensor insertion and removal procedures for the device were also well-tolerated in subjects studied. Further, patients in the study expressed a high degree of likeability for the Eversense system as relates to its features, which could make it a valuable tool for improved diabetes management.”
In this prospective, unblinded, single-arm, single-center study, pediatrics (n=30) and adults (n=6) with diabetes were evaluated on the accuracy and safety of the Eversense XL CGM System through the 180-day study duration. When referenced against a lab analyzer, the findings demonstrated the accuracy of Eversense XL (MARD of 9.4 percent, 15/15 percent metric of 83 percent, and 99.6 percent of consensus error grid data in zones A and B). Study participants also expressed an overall favorable rating of the system (long sensor life, implantable wear and vibratory alerts). No serious adverse events related to the insertion/removal of the sensor or device were reported.
In another third party study conducted by the MGH Bionic Pancreas Monitoring Study group, each of Eversense, Dexcom G5 and Libre Pro were worn simultaneously by 23 subjects and evaluated using blood glucose meter as the reference method. In the three-way comparison study, Eversense achieved the lowest nominal MARD (14.8 percent) followed by Dexcom G5 (16.3 percent) and Libre Pro (18 percent).
“We found that the point accuracy of the Eversense was significantly better than two other CGM systems,” the study’s authors said. “The Eversense CGM system may be useful to provide glucose values to artificial pancreas devices.”
On June 21, the U.S. Food and Drug Administration (FDA) approved Senseonics’ Pre-market Approval (PMA) application to market the Eversense CGM System in the United States to people age 18 and older with diabetes for up to 90 days.
“On the heels of the U.S. FDA approval of the Eversense CGM System, we are pleased to see these new data evaluating the long-term safety and accuracy of the device,” said Tim Goodnow, president and CEO of Senseonics. “We look forward to further advancing the science of CGM research, which includes demonstrating clinical support for new product indications for wider populations with an even longer sensor life. In particular, we believe the results of the pediatric study will potentially help inform the design of our future pediatric clinical trials.”
The Eversense System is the first and only CGM system approved by the FDA to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
The Eversense Continuous Glucose Monitoring System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is performed by a physician.