Senseonics Reaches Primary Effectiveness and Safety Endpoints in Study for Continuous Glucose Monitoring

Senseonics has met its primary effectiveness and safety endpoints of the interim phase of the PRECISE (A Prospective, Multicenter Evaluation of the Accuracy of a Novel ContinuousImplanted Glucose Sensor) Study. The company is working on developing the first fully implantable, long-term continuous glucose monitoring (CGM).

According to the press release:

The interim phase was pre-specified in the study to determine the effectiveness and safety of the company’s long-term implantable CGM system for the first 90 days of continuous glucose sensor wear.

Jort Kropff, MD, co-investigator at Academic Medical Centre, University of Amsterdam, presented the study results at last week’s 15^th Annual Diabetes Technology Meeting in Bethesda, Maryland. Results from 44 subjects with diabetes demonstrated strong accuracy throughout the entire 90-day continuous wear period with a mean absolute relative difference (MARD) of 11.4% in the 75 – 400 mg/dL range when compared to YSI blood reference values. The mean absolute difference (MAD) in the < 75 mg/dL range was 13.5 mg/dL. Eighty-four percent (84%) of the sensor values were within 20% of the YSI reference. There were no significant adverse events reported related to the Senseonics CGM system.
Subjects underwent bilateral sensor insertions in the clinic on day 1 and used the system’s smart transmitter and mobile app at home for the next 90 days. Subjects were able to view their real-time glucose readings and trends during home-use and sensor readings were not used to adjust their treatment. Clinic visits were scheduled throughout the 90 days in order to obtain lab reference glucose values for comparison with the sensor values.

 
Click here to read the full press release.