Senseonics Holdings, Inc. (NYSE: SENS) announced the results of its PROMISE Study that evaluates the accuracy and safety of the Eversense CGM System for up to 180 days with reduced calibrations. Data was presented by Satish Garge, MD, Professor of Medicine at the Barbara Davis Center of the University of Colorado, Denver. Results were presented for both primary and secondary sensors with modified chemistry in a subset of study participants. “The value of CGM for patients with diabetes, especially those requiring insulin, is unquestioned,” said study PI, Dr. Satish Garg. “To enable more patients to utilize CGM, there needs to be choice in product features. The accuracy profile demonstrated by Eversense in the PROMISE Study validates the role that long-term implantable CGM systems can play in helping people manage their glucose levels.”
“We are very pleased with the results of the PROMISE Study which demonstrate an excellent safety and accuracy profile for the 180-day sensor. This study was initiated December 2018 and we’re very grateful to the tireless Clinical Investigators and the devoted study subjects for participating in this important clinical trial,” said Tim Goodnow, PhD, President and CEO of Senseonics. “As we await hearing from the US and European regulatory agencies concerning our pre-market submissions of data from both the primary and the SBA sensors, we are pleased to continue to offer the Eversense CGM systems in both the US and Europe with our commercialization partner, Ascensia Diabetes Care.”
For full Study Results please view here.