CGM Safety Information

Continuous Glucose Monitor (CGM) – Patient Safety Information

Continuous glucose monitoring (CGM) devices have traditionally been used to replace finger-prick blood glucose testing for detecting trends and tracking patterns in glucose levels in persons with diabetes. The systems are intended for single patient use and require a prescription.

Your Levels-affiliated physician may prescribe a continuous glucose monitor (CGM) for general health information and wellness purposes, to observe trends and relationships between diet and lifestyle choices and glucose levels. CGMs acquired through a Levels partner-physician are not intended for, and should not be used for the observation or treatment of any medical condition, disease, or diagnosis, including diabetes.

CGM systems that may be prescribed include the Abbott FreeStyle Libre 14-day.

Abbott FreeStyle Libre and other continuous glucose monitoring (CGM) systems are not specifically approved by the FDA for general information and wellness purposes, and use of a CGM for general information and wellness purposes is an off-label use.

What is an ’off-label use’?

When a doctor prescribes a drug or device for off-label use, this means that the physician is prescribing the drug or device in a way that is different than what is in the FDA approved labeling for the drug or device. When the FDA approves a drug or device, the approved labeling specifies, among other things, the diseases or conditions for which the drug or device has been approved by the FDA. however, physicians are generally permitted to prescribe a drug or device for an “off label” or “unapproved” use when they determine it is medically appropriate for their patient.

How do continuous glucose monitors work?

Continuous glucose monitors consist of a sensor with a thin, flexible filament inserted just under the skin to measure glucose within the body, and a wireless reader device or smartphone app to receive and record the sensor data.

What are the contraindications of continuous glucose monitors (CGM)?

CGM sensors must be removed before magnetic resonance imaging (MRI), computed tomography (CT) scans, X-ray, or high-frequency electrical heat (diathermy) treatment.

CGM sensors have not been tested in these situations and the heat and magnetic fields could damage or destroy the sensor.

The FreeStyle Libre should not be used by pregnant women or persons on dialysis, as it has not been evaluated in these populations.

Abbott Freestyle Libre Full Indications and Important Safety Information:

https://www.freestylelibre.us/safety-information.html

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