Senseonics announced the start of the PRECISE II (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Study in people with diabetes in the United States.
The PRECISE II study will evaluate the long-term safety and effectiveness of the company’s Eversense® Continuous Glucose Monitoring (CGM) System, which is expected to be the first fully implantable, long-term CGM system in the world.
"The start of the PRECISE II study is an important milestone for the company. We have completed the original PRECISE multi-site European pivotal study demonstrating very strong results including meeting all primary endpoints. We believe this U.S. based PRECISE II study will continue to demonstrate the system’s safety and effectiveness enabling us to submit necessary data to the U.S. Food and Drug Administration for our PMA approval," said Dr. Tim Goodnow, CEO and President of Senseonics.
"CGM systems allow people with diabetes to continuously monitor their glucose 24/7, to see glucose trends and patterns, and be alerted to clinically significant high and low glucose levels," said Dr Ronald Brazg, Clinical Investigator at Rainier Clinical Research Center, Seattle, Washington.
"What is different about the Eversense system is that it is implanted in the upper arm for continuous 90 day use, versus the transcutaneous 7-day sensors used by current CGM systems. We began enrolling subjects last week, and yesterday we had the very first PRECISE II subject successfully inserted with the sensor. We’re excited to follow this subject, and all the other study subjects, for 90 days to evaluate the system’s performance."
The primary objectives of the PRECISE II study are to determine the accuracy, and to demonstrate the safety, of the Eversense system through 90 days post-insertion. The PRECISE II is a non-randomized, blinded, prospective, single-arm, multi-center study, enrolling adult subjects with diabetes at up to 10 U.S. sites.
The investigation will include both clinic visits and home use of the system. The CGM glucose results and all glucose related alarms and alerts will be blinded to the study subject for the duration of the study.