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Eversense XL CGM User Guide
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Indications for Use
The Eversense XL CGM System is indicated for continually measuring interstitial fluid glucose levels in adults (18 years
and older) with diabetes for the operating life of the sensor.
The system is intended to:
• Aid in the management of diabetes.
• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycaemia) and high blood
glucose (hyperglycaemia).
Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should
be based on patterns and trends seen over time.
The system is indicated for use as an adjunctive device to complement, not replace, information obtained from
standard home blood glucose monitoring devices.
Contraindications
The sensor and smart transmitter are incompatible with magnetic resonance imaging (MRI) procedures. Patients
should not undergo an MRI procedure while the sensor is inserted or when wearing the smart transmitter. Should an
MRI be required the sensor must be removed before the procedure.
• The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be
contraindicated.
• Therapeutics products such as mannitol intravenous and irrigation solutions may increase blood mannitol
concentrations and cause falsely elevated readings of sensor glucose results.
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