番茄社区

The FDA approved the first long-term implantable continuous glucose monitor (CGM) today, the maker Senseonics announced.

The Eversense CGM System features an implantable glucose sensor that can remain in place for up to 3 months, beating out the usual wear time of 3-10 days for many of the other CGMs currently available.

The small cylindrical device, measuring 3.5 × 18.3 mm, is made of a fluorescence-based glucose sensor implanted subcutaneously under local anesthesia in the patient's upper arm. The glucose data is then transmitted via Bluetooth to the user's mobile application and stored in a HIPAA-compliant cloud. Indicated for use in adults age 18 and older with diabetes -- type 1 or type 2 diabetes -- the CGM is intended to be used in addition to traditional fingerstick blood glucose monitoring.

This approval comes as no surprise, after an FDA advisory committee voted unanimously in March to recommend the device for approval. The panel's backing and the FDA's final approval were largely based upon positive findings from the multicenter PRECISE II trial, which tested the system in 90 patients with type 1 or type 2 diabetes.

Although the device's accuracy during the first 30 days of wear in the trial was questioned during the committee meeting, the overall accuracy of the device throughout the 90-day study was high, with a mean absolute relative difference of 8.5% (95% CI 8.0%-9.1%) from 15,753 unique readings. The device was also able to alert the user to 98% of hyperglycemic events and 96% of hypoglycemic events -- however, 17% and 16% of these were false positives.

Much of the latest research involving this CGM system is expected to be presented at the upcoming 78th Scientific Sessions of the American Diabetes Association, including the first-ever assessment of Senseonics' Eversense XL CGM for use for up to 180 days in adolescents with type 1 diabetes.

Comment