Device Safety

Professional Insertion Helps Reduce Member Error and Risk

Eversense’s unique fully inserted subcutaneous sensor is designed to be inserted and removed by a healthcare provider in a clinical setting. This can reduce the risk of injuries, site infections and other adverse events associated with patient self-removal and insertion in the home.

Make Incision

~ 5 mm Incision in upper arm
under local anesthetic

Insert Sensor

Sensor inserted with custom insertion tool

Close Insertion Site

Steri-Strips^TM to close

Testimonial

“The study had demonstrated the safety of an implanted CGM system in a controlled multicenter clinical trial and did not expose any unanticipated risks.”*

PRECISION Trial

2017

No Device-Related Serious Adverse Events (SAE) Across Three Major Studies^2-4

In three pivotal studies (PRECISE, PRECISE II, and PRECISION), the Eversense CGM System demonstrated an excellent safety profile, as measured by the incidence of adverse events tied to the device or sensor insertion/removal procedures, during continuous use for up to 90 days.⁵

Safety Paper

To learn more on how a professionally-inserted CGM system can reduce risk to members, contact us to get a copy of our device safety paper.

1 Christiansen MP, et al. PRECISION. Diabetes Technology & Therapeutics, Volume 21, Number 5, 2019. 2 Kropff J, Choudhary P, Neupane S, et al. PRECISE. Diabetes Care. 2017;40(1):63-68. 3 Christiansen MP, Klaff LJ, Brazg R, et al. PRECISE II. Diabetes Technol Ther. 2018;20(3):197-206. 4 Christiansen MP, et al. PRECISION. Diabetes Technology & Therapeutics, Volume 21, Number 5, 2019. 5 PRECISE II Pivotal Trial of A Long Term Implantable CGM System: 90 Days of Sustained Accuracy and Strong Safety Profile. 2017.

MKT-001295 Rev1

Disclaimer

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The Eversense®XL Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 180 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is performed by a health care provider. The Eversense XL CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see global.eversensediabetes.com/safety-info.