Senseonics Initiates PRECISE II U.S. Trial of Long-Term CGM

Senseonics Holdings, Inc. (OTCBB:SENH) has started 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 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.
According to the company press release:

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.

Senseonics Initiates PRECISE II U.S. Trial of Long-Term CGM commented:

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.

Click here to view the full press release.