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The Eversense® 365 CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Physiologic differences between ISF and blood from a finger stick may result in differences in glucose measurements. These differences are especially evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising). On average, glucose levels in ISF lag behind glucose levels in blood by several minutes.

The trend arrow on the My Glucose screen of the Eversense® App screen will give you an indication of which direction the glucose is moving towards, up or down and the rate of change.

Initialization Phase (after 24-hour Warm-Up Phase)

During the Initialization Phase, four (4) finger stick blood glucose meter tests are required for calibration.

The 4 calibration tests must be spaced 2 to 12 hours apart, and all 4 tests must be completed within a 36 hour period.

– 1st calibration = 24 hours after sensor insertion.

– 2nd calibration = 2 to 12 hours after 1st successful calibration.

– 3rd calibration = 2 to 12 hours after 2nd successful calibration.

– 4th calibration = 2 to 12 hours after 3rd successful calibration.

Glucose readings will start displaying in the app a few minutes after the 2nd calibration is successfully completed.

No glucose readings will be displayed. Always charge immediately when the smart transmitter battery is completely drained.  The system will return to Initialization phase if the battery is not charged within 16 hours of a Battery Empty alert.

The mobile app will also display a “No Transmitter Detected” status banner.

The Eversense® 365 Smart Transmitter is water resistant to an Ingress Protection Rating of IP67. This means you can submerge in water 1 meter (3.2 feet) deep for up to 30 minutes. You can take showers and swim without extra protection. Exposing the smart transmitter to conditions beyond this will result in damage and void your warranty.

Sensor: The sensor is considered medical waste and will be disposed of by your health care professional.

Transmitter: The transmitter contains a reusable battery and should be disposed of based on your local regulations.

Adhesive patch: The adhesive patch can be thrown away with normal household trash.

The Low Battery Alert appears once when smart transmitter battery power is very low (less than 10 hours remaining), and you need to charge your battery very soon. If you receive the alert, charge your smart transmitter as soon as possible.

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The Eversense® 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to one year in people (18 years and older) with diabetes. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are required for calibration one time a week after day 13, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense 365 CGM System is a prescription device; patients should talk to their health care provider to learn more.

For important safety information, see bit.ly/eversensesafety

Eversense, Eversense 365 Continuous Glucose Monitoring, and the Eversense logo are trademarks of Senseonics, Incorporated. All other trademarks are properties of their respective owners and are used solely for informative purposes. No relationship or endorsement should be inferred or implied.


Apple Watch® is a product of Apple, Inc., and may be separately purchased from an authorized Apple retailer. Apple Watch is not included with the Eversense CGM System. Android is a trademark of Google LLC.

 

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