February 2019
Daily diabetes monitoring hurts. If you or someone you love has diabetes, you're probably familiar with the tedious routine of glucose monitoring, the painful fingersticks to draw a drop of blood and the bulky traditional glucose monitoring equipment requiring daily calibrations. These inconveniences can make it difficult to stick to a diabetes management plan, opening the door for complications to arise.
What if you could take the pain and inconvenience out of glucose monitoring and experience a better way of managing the condition?
For the 30.3 million Americans who have diabetes, the U.S. Food and Drug Administration's approval of the FreeStyle® Libre is that life-changing experience. The revolutionary system eliminates the hurdles of traditional glucose monitoring and requires no routine fingersticks or fingerstick calibrations.
Across the globe, more than 400,000 people are using the FreeStyle Libre, and the system has been clinically proven to be accurate, stable and consistent.
How Does Continuous Glucose Monitoring With the FreeStyle Libre System Work?
The FreeStyle Libre system measures glucose levels through a small sensor — the size of two stacked quarters — applied to the back of your upper arm. It provides real-time glucose readings for up to 10 days, both day and night. The sensor can also read glucose levels through clothes, making testing discreet and convenient.
The FreeStyle Libre system provides three critical pieces of data with each scan:
The touch-screen reader also holds up to 90 days of data, which allows people to track their glucose levels over time.
How Does the FreeStyle Libre System Help Improve Treatment?
The data generated by the FreeStyle Libre system is designed to provide actionable trends and patterns that help you make better decisions about your health, such as adjustments to your diet or how much insulin you need to take. For example, the reader's snapshots can reveal if a person is experiencing hypoglycemic trends (low glucose levels) patterns or hyperglycemic trends (high glucose levels), which can aid in choosing the right diabetes management.
Studies show that FreeStyle Libre users who scan more frequently spend less time in hypoglycemia and experience improved average glucose levels. According to a study published in The Lancet, people using the FreeStyle Libre system spent 38 percent less time within hypoglycemia as compared with those who managed their glucose with traditional self-monitoring glucose system.
Diabetes doesn't have to control your life. It's time to live freely.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
The FreeStyle Libre Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) device indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The FreeStyle Libre system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre system is not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of bloodborne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. Review all product information before use or contact Abbott Toll-Free (855-632-8658) or visit www.freestylelibre.us detailed indications for use and safety information.
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