Medical technology firm Senseonics has completed patient enrolment in the Eversense PROMISE 180-day sensor clinical study of Eversense continuous glucose monitoring (CGM) system in people with diabetes.
The study will evaluate the safety and efficacy of the implantable CGM system for pre-market application submission to the US Food and Drug Administration (FDA).
The system has already received its CE Mark and is currently available for commercial use across Europe.
A total of 181 participants were involved in the study at eight sites across the US. They had the Eversense CGM system inserted subcutaneously as part of the study.
Senseonics Clinical Sciences vice-president Katherine Tweden said: “This is the first study in the US in which study participants are implanted with a single sensor, which will produce accurate continuous glucose measurements for up to half of a year.
“We expect to have the full data for analysis at the end of the first quarter of 2020 for submission to the FDA later that year.”
Eversense is a glucose-monitoring product designed to help people with diabetes. Glucose data is automatically sent every five minutes to a mobile app that displays glucose values, trends and notifications on the user’s smartphone.
The CGM System can continuously measure glucose levels in persons age 18 and older with diabetes for up to 90 days.
Soon the system will be used to replace fingerstick blood glucose (BG) measurements to make further decisions on diabetes treatment.
In March, Senseonics agreed to integrate data from the Eversense CGM system into the Glooko diabetes data management platform directly from the Senseonics Cloud.