eversense XL - 2 Benefits and Risks

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Eversense XL CGM User Guide
2
2. Benets and Risks
This section describes the benets, expectations and risks associated with using the Eversense XL
CGM System.
Continuous glucose monitoring aids in the management of diabetes and glucose control, which can improve your
quality of life. Best results are achieved when you are fully informed about the risks and benefits, insertion procedure,
follow-up requirements, and self-care responsibilities. You should not have the sensor inserted if you cannot properly
operate the CGM System.
The CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Physiologic dierences between
ISF and blood from a fingerstick may result in dierences in glucose measurements. These dierences are especially
evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising). Glucose levels
in ISF lag behind glucose levels in blood by several minutes.
The sensor has a silicone ring that contains a small amount of an anti-inflammatory drug (dexamethasone acetate).
It has not been determined whether the risks associated with injectable dexamethasone acetate apply to the
dexamethasone acetate elution ring inside the sensor. The elution ring releases a small amount of dexamethasone
acetate when the sensor comes in contact with body fluids and serves to minimise the body’s inflammatory response to
the inserted sensor. Dexamethasone acetate in the ring may also cause other adverse events not previously seen with
the injectable form. For a listing of potentially adverse eects related to dexamethasone acetate, contact your doctor.
Unauthorised modifications of the equipment, improperly accessing information within it or “jailbreaking” your
system, and taking any other unauthorised actions may cause the CGM system to malfunction and may put you at
risk. Unauthorised modification of the equipment is not permitted and voids your warranty.