Senseonics to Start CGM Trial
Germantown, Md.-based Senseonics is kicking off the new year with a study evaluating the long-term safety and effectiveness of its Eversense continuous glucose monitoring system.
Eversense would be the first fully implantable, long-term CGM system in the world, according to the company, which merged with ASN Technologies last month.
The study, dubbed PRECISE II, aims to provide data backing the system’s safety and effectiveness for a PMA approval. PRECISE II is a nonrandomized, blinded, prospective, single-arm, multicenter study that will enroll diabetic adults at 10 sites. The study will evaluate both clinic and home use of the device.
Senseonics President and CEO Tim Goodnow says in a prepared statement that the first PRECISE study in Europe met all primary endpoints. — Elizabeth Hollis