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180 Day CGM (Continuous Glucose Monitoring System): Senseonics’ Eversense XL Approved in Europe.

How does CGM work?

System = sensor + receiver + transmitter

Sensor: stick under your skin, measure levels continuously for 180 days

Transmitter; sends glucose information measured by the sensor to the receiver.

Receiver; acquire and display glucose information is a portable device.

Senseonics, which is normally planned to remain implanted for 90 days, has been approved for a lifetime of up to 180 days. The Senseonics’ Eversense XL continuous glucose monitoring (CGM) system with implante sensor is approved in Europe. This decision doubles the life span of the previously approved 90-day Senseonics. This means that Senseonics can be used 12 times longer than other CGM sensors in Europe.

Congress of Advanced Technologies & Treatments for Diabetes – Paris 2017

Senseonics plans to launch the Eversense XL in Europe this year. The 90-day version of Senseonics is expected to get FDA approval in the USA this year or early 2018.

Like the 90-day Eversense CGM system, the 180-day Eversense XL has a small sensor implanted into the upper arm. (~ 5/8 inches in length and ~ 1/8 inches in diameter, a little bit bigger than a pill) It is implanted under the skin with a small operation for 5-10 minutes. It is placed in the skin only by local anesthesia and after a small incision about 5 to 8 mm in length.

The user then attaches a rechargeable transmitter on the skin above the directly implanted sensor. The transmitter sensor, which can be removed and / or re-inserted at any time, provides power and a smart phone displays real-time glucose readings and trends.

As we know, it is important to measure and calibrate the finger on the continuous glucose measurement sensors. And even finger control is important in critical sensor glucose values. Accu-Chek’s sensor requires finger-calibrations twice a day like other known continuous glucose measurement systems.