Diabetes: Senseonics launches pivotal of 90-day implantable glucose monitor

Senseonics said today it launched the Precise II trial of its Eversense fully implantable, long-term continuous glucose monitor for individuals suffering from diabetes.

The Eversense monitor uses a subcutaneous sensor and an external, removable smart transmitter linked to a mobile app that delivers real-time glucose levels and can be set to transmit alerts and alarms.

The blinded, non-randomized study is looking to examine the accuracy, safety and efficacy of the Eversense system up to 90-days after implant, the Germantown, Md.-based company said.

“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. 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,” clinical trial investigator Dr. Ronald Brazg of Seattle’s Rainier Clinical Research Center, said in prepared remarks.

The trial is slated to enroll adult subjects with diabetes at approximately 10 U.S. investigation sites. The study will include clinic visits and home use of the Eversense system, and all glucose results, alarms and alerts will be blinded to the study subjects for the entirety of the study.

“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,” CEO Dr. Tim Goodnow said in a press release.

Last week, Senseonics registered for an initial public offering worth up to $51.8 million as it gears up to get its Eversense on the diabetes market.

Senseonics, formed last month via a merger with ASN Technologies, said it applied for CE Mark approval in the European Union last July for Eversense and expects it to hit the market there during the 1st half of this year. A 90-patient U.S. pivotal trial is under way and the company said it could file for pre-market approval from the FDA as soon as the 2nd half of 2016, with a PMA nod expected 6 to 18 months later.

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