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Roche Diabetes Care are proud to announce its collaboration with Senseonics Incorporated to launch Eversense XL in the UK. The Eversense XL CGM System is for people who actively manage their diabetes, and provides advanced long term glucose monitoring via an implantable sensor, a removable and rechargeable transmitter, and convenient smartphone app, allowing patients to confidently live their lives with ease.

How does Eversense XL work?

Based on innovative fluorescence technology embedded within a tiny sensor, the Eversense XL CGM system measures glucose in the interstitial fluid (the fluid between cells). A smart transmitter is worn on the arm, directly over the sensor, and wirelessly powers the data transfer from the sensor.

Glucose reversibly binds to the sensor's polymer coating, and the amount of light emitted by the polymer coating rises and falls with changing glucose levels. Photodetectors in the sensor measure the emitted light and wirelessly send these measurements to the transmitter, which then calculates glucose concentration, rate of change and direction. This glucose data is sent wirelessly to the smartphone app that provides real-time tracking, intuitive displays to help identify patterns, and information to help stay in range. The smart transmitter also provides on-body vibration alerts even if your phone is not nearby or is switched off.

With traditional CGM or Flash GM sensors, you must insert a new sensor every 7 – 14 days. With the Eversense XL CGM system, a new sensor is fully inserted under the skin for up to many months.

Key Features

The Eversense XL CGM system is indicated for people who actively manage their diabetes, and provides advanced glucose monitoring continuously for up to 180 days via an implantable sensor, a removable and rechargeable transmitter, and convenient smartphone app, allowing patients to confidently live their lives with ease.

Simple Implantation

Eversense XL, the first ever implantable continuous glucose monitoring system, measures your sugar (glucose) levels every few minutes through a sensor that is placed under the skin in your arm.
 
1. Download Eversense App to mobile device and create account
2. Pair smart transmitter with smartphone
3. Doctor inserts sensor
4. Link sensor with smart transmitter
5. Calibrate system
 

Eversense XL CGM system frequently asked questions

What is CGM?

Continuous Glucose Monitoring, or CGM, means measuring the amount of sugar (glucose) in your body every few minutes.

How does CGM differ from testing with a blood glucose meter?

A blood glucose meter requires you to take a small sample of blood from your fingertip and place it on a test strip that is inserted inside a meter. The meter provides a glucose value based on the amount of glucose in the blood sample. CGM measure the amount of glucose in the fluid between your cells. To provide glucose values every few minutes, a sensor is inserted just below your skin.

Is CGM better than just testing with a blood glucose meter?

One significant benefit of CGM is that it provides a ‘moving’ picture of how your glucose levels change over time. This makes it easier for you to see how diet, exercise and other health factors affect your glucose.

How is the Eversense XL CGM different from other CGM systems?

The Eversense XL implantable sensor can last up to 180 days. This compares to other current CGM systems that require weekly or even more frequent sensor insertions. A removable, rechargeable and water-resistant smart transmitter provides on-body vibration alerts, even when your smartphone is not nearby. A smartphone app allows you to integrate the Eversense XL CGM system with a device you already use. Having all your data on your smartphone means you don’t have to carry another receiving device. Most other systems require a separate receiving device to provide the data, alerts and notifications.

How long does the insertion of the sensor take, and can I do it myself?

The sensor is implanted subcutaneously (under the skin) into the upper arm. Inserting the sensor takes about five minutes, and must be done in the clinic. The sensor must also be removed and replaced in the clinic.

Is the insertion painful?

The sensor is inserted under a local anaesthetic. However, you may experience some mild discomfort from the injection of the local anaesthetic or during the procedure.

How long can the sensor remain implanted?

The sensor can continue to provide readings for up to 180 days before it must be changed. A new subcutaneous pocket will be created at a different site for the new sensor.

How often does the Eversense XL CGM need calibrating?

After initial calibration which requires four blood glucose calibrations 2 – 12 hours apart, the Eversense XL CGM should be calibrated twice daily (the smartphone app will provide an alert).

How big is the sensor implanted in the arm?

The sensor measures 18.3 mm by 3.5 mm.

How big is the smart transmitter I have to wear on my arm?

The smart transmitter measures 37.5 mm by 48 mm and is just 8.8 mm thick. It weighs 11.3 g.

How is the smart transmitter fixed to the arm?

The smart transmitter is fixed to the arm using a silicone-based adhesive tape designed for daily use.

How do I charge my transmitter? 

The transmitter should only be charged using the special adapter provided. It takes approximately 15 minutes using a wall outlet to completely re-charge the transmitter.

Is the smart transmitter waterproof?

The smart transmitter is water-resistant to a depth of 1 metre for up to 30 minutes. You can keep it on in the shower or bath but you may want to use this time to charge the transmitter. Please note that it takes 15 minutes using a wall outlet to completely re-charge the transmitter.

Clinical summary

The multicentre European PRECISE Study (Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) aimed to determine the accuracy and safety of the Eversense Continuous Glucose Monitoring (CGM) system over successive periods of 30 days for up to 6 months.1

With regard to accuracy, the primary endpoint of MARD (mean absolute relative difference) was 11.6% over the range of 2.2 - 22 mmol/L against venous glucose references (using YSI2300 Stat Plus).

Average reduction in HbA1c over 180 days was 0.35%.

Wear-time compliance for the smart transmitter was good, with a median wear time of 23.5 hours/day (mean 22.3 hours/day). There were no significant adverse events.

Overall participants scored the Eversense CGM system very high on ease of use, convenience, and comfort. Participants were able to wear the transmitter in their everyday setting throughout 180 days of wear. Most stated they would have the Eversense CGM system inserted again.2

  1. Kropff J et al. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care, 2017; 40: 63 – 68.
  2. Barnard K et al. Acceptability of Implantable Continuous Glucose Monitoring Sensor. Journal of Diabetes Science and Technology. Published October 8, 2017. (https://doi.org/10.1177%2F1932296817735123)