HUMA
October 15, 2023
Article of the Month – October 2023
October 15, 2023Eversense CGM System®
EVERSENSE CGM SYSTEM® a continuous glucose monitoring device
Available since 2018, Eversense was introduced by the Maryland-based company Senseonics. It stands as the pioneering long-term, minimally sized continuous glucose sensor implanted beneath the skin, offering real-time glucose monitoring for up to 90 days. The sensor, a small transparent rod, is entirely implanted under the skin, requiring a quick, less-than-10-minute surgical procedure typically performed in a doctor’s office. The implantation process utilizes Lidocaine and a specialized instrument to place the sensor in a skin pocket securely. While FDA-approved for upper arm usage, some individuals have opted for implantation in their abdomen. Following placement, the sensor requires a 24-hour warm-up period before becoming fully operational.(1,2)
The Eversense® E3 CGM system consists of a glucose sensor, Smart Transmitter, and Mobile Medical Application designed for glucose monitoring. The sensor, powered wirelessly by the Smart Transmitter, uses LED light and a fluorescent polymer coating to measure glucose levels in the body. Photodetectors capture the emitted light, converting it into digital data sent to the Smart Transmitter. This device processes the data, calculating glucose values, trends, and rate of change, accessible through the mobile app. FDA regulations require two daily fingerstick calibrations for accuracy. Eversense offers a convenient, safe, and comfortable solution, allowing continuous use for up to 6 months. Its silicone-based adhesive ensures secure and irritation-free wear, promoting flexible and reliable usage.(1,2)
Continuous glucose monitoring (CGM) has revolutionized diabetes management for insulin-treated patients, offering real-time insights crucial for effective control. Among the cutting-edge CGM systems, the Eversense CGM stands out with its groundbreaking fully implantable sensor, an innovation that lasts an impressive 180 days. The accuracy of this system is noteworthy, boasting a mean absolute relative difference (MARD) of 9.4%, ensuring reliable glucose monitoring over an extended period. Additionally, the 180-day sensor demonstrates an impressive 84% agreement rate and a remarkable 99.2% accuracy within the A and B zones of the Clarke Error Grid.(3)
Clinical trials and real-world data sets consistently show that using this long-term sensor leads to a significant reduction in A1c levels by approximately 0.4%. Equally important, patients experience a substantial increase in the time spent within the target glucose range, enhancing overall glycemic control. Notably, the sensor’s impeccable performance is complemented by its excellent tolerability. Pivotal trials have reported no device-related serious adverse events, and the rate of device and procedure-related adverse events remains below 1%. The most common issues reported include site irritation, occasional difficulty in sensor removal, and site infections. This remarkable combination of accuracy, durability, and safety underscores the Eversense CGM as a game-changing advancement in diabetes care, promising enhanced quality of life for individuals managing this chronic condition.(3,4)
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