FreeStyle® Libre Approved in the U.S.
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Abbott’s FreeStyle Libre system is a revolutionary system for the millions of adults with diabetes in the United States. FreeStyle Libre system eliminates the hurdles of traditional glucose monitoring by removing the need for routine finger sticks and finger stick calibrations. With the approval of Abbott’s FreeStyle Libre system by the U.S. Food and Drug Administration, people with diabetes in the U.S. are able to measure glucose levels through a small sensor applied to the back of the upper arm. The sensor, which is the size of two stacked quarters, 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 people with diabetes three key pieces of data with each scan: a real-time glucose result, an 8-hour historical trend, and a trend arrow showing the direction their glucose is going. The touch-screen reader holds up to 90 days of data, which allows people to track their glucose levels over time.
Across the globe, more than 400,000 people are now using the FreeStyle Libre and the system has been clinically proven to be accurate, stable, and consistent , .
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 blood borne 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 for detailed indications for use and safety information.
Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose
Based on the sensor being replaced once every 10 days, and scanned at least once every 8 hours
The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor
Data on file. Abbott Diabetes Care
Bolinder, Jan, et al. Novel glucose-sensing technology and hypoglycemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The Lancet 388.10057 (2016): 2254-2263
Haak, Thomas, et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Therapy 8.1 (2017): 55-73