Indications and Safety Information
The FreeStyle Libre 14 day System is designed for managing diabetes in adults aged 18 years and older. It is a tool for monitoring glucose to inform diabetes treatment and is not a replacement for traditional blood glucose monitoring. The system helps to identify glucose level trends and patterns, which is crucial in both short-term and long-term diabetes management. The device should be used by a single patient and a prescription is required.
Contraindications
Before undergoing Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scans, or diathermy treatments, the device must be removed. The effects of these procedures on the device’s functionality have not been studied; however, they may cause damage to the sensor and result in inaccurate readings.
Warnings
Users should not ignore symptoms of abnormal blood glucose levels. In certain situations, such as inconsistent readings with symptoms, rapid glucose changes, or during the first 12 hours of sensor wear, fingerstick testing with a traditional blood glucose meter is necessary. Treatment decisions should not be made solely on sensor glucose readings in these situations.
Sensor readings may sometimes need to be verified with a fingerstick test, such as when hypoglycemia is suspected or the readings do not include a current glucose number or trend arrow. It is also crucial to use a separate blood glucose monitoring system alongside the FreeStyle LibreLink app, as the app does not include this feature.
The system does not have alarms for automatic notifications of severe low or high glucose events; the user must scan their sensor to receive this information. Additionally, the device’s small parts pose a choking hazard and should be kept away from children.
Limitations
This CGM system is not evaluated for individuals with hypoglycemic unawareness and will not alert the user to hypoglycemic events without sensor scanning. There are no alarms that would automatically notify of glucose events during sleep or at other times without a manual sensor scan.
References:
Download: FreeStyle Libre 14 day System IN-SERVICE GUIDE
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