The data, published in Diabetes Technology and Therapeutics, included the first 205 U.S. patients to use Germantown, Md.-based Senseonics’ Eversense system over a 90-day wear period.
Zero device or procedure-related adverse events were reported with the Eversense system, which is meant to be subcutaneously inserted into the upper arm by a health care provider.
Senseonics said Eversense features the first long-term and implantable CGM sensor, along with a transmitter that sends discreet vibrations to alert users of low or high glucose. The device can be removed, recharged and re-adhered without discarding the sensor.
“This real-world data reflects how the Eversense CGM functions for people who choose this innovative, implantable system to manage their diabetes,” Senseonics CMO Dr. Francine Kaufman said in prepared remarks. “The data shows that glucose control, as measured by time in range, is achievable and that there is minimal hypoglycemia. The high wear time and safety record demonstrate that patients are able to rely on the Eversense System in their day-to-day setting. We’re looking forward to sharing these results with the payer community as we seek further coverage for Eversense as a clinically-proven choice in a patient’s CGM therapy.”
Senseonics launched Eversense in August 2018, about two months after FDA approval. The follwing November, Eversense won FDA approval, enabling nurse practitioners and physicians assistants — not just trained physicians — to implant and remove the device. It was also approved by the FDA on June 10 as a replacement for fingersticks.