The company submitted a premarket approval (PMA) application to the FDA for Eversense CGM system.
Senseonics recruited 90 adults with Type 1 or Type 2 diabetes at eight US clinical centers in the PRECISE II trial to evaluate the safety and efficacy of Eversense CGM system over 90 days of continuous glucose sensor wear.
According to the company, the participants in the study used the system’s smart transmitter and mobile app at home for the next 90 days.
The firm carried out calibration twice a day and calculated sensor glucose readings prospectively, but real-time glucose readings and trends were not provided to participants.
Senseonics will reveal the results of the study at this year’s Diabetes Technology Meeting in Bethesda of Maryland on 10 November.
In May this year, the company received CE mark approval for the Eversense CGM system, and is currently marketing in select European countries.
Senseonics president and CEO Dr Tim Goodnow said: “The submission of our PMA marks a significant milestone toward meeting our goal of bringing an accurate, reliable and long-lasting CGM system to people with diabetes in the United States.
“We look forward to working with the FDA to receive approval as quickly as possible.”
Senseonics is engaged in the development and commercialization of glucose monitoring products for the treatment of diabetes patients.
