Senseonics Holdings has secured approval from the US Food and Drug Administration (FDA) to extend the PROMISE sensor study of the Eversense continuous glucose monitoring (CGM) system.
The regulator has approved a subgroup of the trial participants to continue for a total of 365 days to collect feasibility data on the safety and accuracy of a 365-day sensor.
The PROMISE trial is evaluating the safety and efficacy of the Eversense CGM system in people with diabetes
The PROMISE trial has been designed to assess the safety and efficacy of the Eversense CGM system in people with diabetes over a 180-day period for the pre-market application submission to the FDA.
The Eversense CGM system has been inserted subcutaneously in 181 study participants at eight sites across the US as part of the study, which is completing the 180-day duration in March.
The latest FDA approval allows to continue a sub-set of over 35 participants who all had a sensor with the modified chemistry for 365 days to measure accuracy and longevity over the complete year.
The Eversense CGM system helps to continuously measure glucose levels in persons age 18 and older with diabetes for up to 90 days. It is designed to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions.
The system features a fluorescence-based sensor, a smart transmitter worn over the sensor for data communication, as well as a mobile app for showing glucose values, trends and alerts.
The system also includes a smart transmitter, which offers wearers with on-body vibratory alerts for high and low glucose.
Senseonics president and CEO Dr Tim Goodnow said: “The scientific, clinical and technical data we will obtain will be critical to further extend sensor longevity.
“We’re very grateful to the FDA for the green light, for the tireless clinical investigators, and particularly, to the devoted study participants for giving us this opportunity.”
In 2016, Senseonics secured CE mark approval for the Eversense CGS system.
