Senseonics (NYSE:SENS) yesterday touted real-world data it said demonstrated the safety and lack of adverse events with its Eversense continuous glucose monitoring system for people with diabetes.
Eversense is a long-term, implantable GCM sensor with a transmitter that sends discreet vibrations to alert users of low or high glucose. The device can be removed, recharged and re-adhered without discarding the sensor.
Data from a two-year post-market registry in Europe showed no serious adverse events and a low rate of related adverse events following multiple sensor insertion and removal cycles.
In all, 5,417 sensors were inserted, for a total 1,260 patient-years of followup. Over the two years of data collection, 0.96% of patients experienced sensor-site infection and 0.66% showed irritation from the adhesive patch, according to the study, published in Diabetes Technology & Therapeutics.
“The difference between real-world data and clinical trial data is that the clinical study environment is highly controlled with respect to patient selection, clinic visit activities and interaction with clinicians and the real-world data is from patients who use the device in their everyday lives with minimal interaction with their health care provider,” president & CEO Tim Goodnow said in prepared remarks. “All of these clinical trial factors have an effect on the outcome and do not always match the real-world performance in the home-use setting. At Senseonics, we are focused on how our users actually integrate Eversense into their everyday lives. We were pleased that we saw these positive safety outcomes from our users over multiple sensor cycles. It also demonstrates that there is a large population of CGM users who prefer Eversense to manage their diabetes.”
“This post-market analysis was an opportunity to evaluate the real-world experience of Eversense and Eversense XL CGM as patients wore their first, second, third and up to eighth sensors,” added lead author Dr. Dorothee Deiss, of Berlin’s Medicover. “With this large sample size of data, we were pleased to see that the European Eversense PMCF registry clearly demonstrated the safety of the Eversense CGM System in thousands of patients. The results, with more than 5,000 sensors inserted and a total of more than 1,200 patient-years of wear, clearly demonstrated a favorable safety profile over repeat sensor cycles for the only long-term implantable sensor.”
Last week Senseonics touted real-world data from a study of 205 U.S. patients using Eversense over a 90-day wear period. That study reported zero device or procedure-related adverse events from Eversense implementation. The system was launched in August 2018 and has since won FDA approval to enable nurse practitioners and physicians assistants, not just trained physicians, to implant and remove the device.
