eversense CGM - 2 Benefits and Risks

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Eversense CGM User Guide
2. Benets and Risks
This section describes the benets, expectations and risks associated with using the Eversense
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), and for some
people, during the first several days after insertion due to inflammation that may result from the insertion procedure.
Glucose levels in ISF lag behind glucose levels in blood by several minutes.
IMPORTANT: If your symptoms do not match the glucose alerts and readings from the Eversense CGM
System, a fingerstick blood glucose check with a home blood glucose meter should be performed prior to making
treatment decisions.
Failure to use the Eversense CGM System in accordance with the instructions for use may result in you missing a
hypoglycemic or hyperglycemic glucose event, which may result in injury.
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 minimize 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
health care provider.
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