Hi, FreeStyle Libre System. Bye, Routine Finger Sticks (1)

Have diabetes? This glucose monitoring tool could revolutionize your life with fast, reliable results without the need for routine finger sticks1.

Products and Innovation|Sep. 27, 2017

Daily diabetes monitoring hurts. If you or a loved one has diabetes, you’re probably familiar with the tedious routine of glucose monitoring. The painful finger pokes to draw a drop of blood. The daily fingerstick calibrations. Or the expensive, bulky CGM equipment.

For many, that's been the reality. But what if you could take the pain and inconvenience out of glucose monitoring? What if you could transform the way people with diabetes manage their condition? Well, today, you can.

For the 30 million Americans who have diabetes2, the approval of the FreeStyle Libre Flash Glucose Monitoring System by the U.S. Food and Drug Administration is a significant stride in offering new options for people with diabetes in the United States.

We've introduced a revolutionary system that eliminates the hurdles of traditional glucose monitoring. No routine fingersticks1. No fingerstick calibrations.

Hi, FreeStyle Libre System. Bye, Routine Finger Sticks (1)

How does the FreeStyle Libre System work?

Abbott's FreeStyle Libre system measures glucose levels through a small sensor applied to the back of your 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 night3. The sensor can also read glucose levels through clothes4, 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 people5 are now using the FreeStyle Libre and the system has been clinically proven to be accurate, stable, and consistent6.

How does the FreeStyle Libre System help?

The data generated by the FreeStyle Libre system is designed to provide actionable trends and patterns that help people make better decisions about their health such as adjustments to their diet or how much insulin they need to take7. Studies show that FreeStyle Libre users who scan more frequently spend less time in hypoglycemia, while experiencing improved average glucose levels8,9 . According to the study8 that was 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.

By tracking and monitoring glucose continuously, the FreeStyle Libre system helps people and their health care providers to better adjust their lifestyle, diet and treatment to suit their needs. For example, the reader's snapshots can reveal if a person is experiencing hypoglycemic (low glucose levels) patterns or hyperglycemic trends (high glucose levels), which can aid in choosing the right diabetes management1.

Want to Learn More?

Go here to learn more about the FreeStyle Libre system.

References:

1Fingersticks 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
2American Diabetes Association. http://www.diabetes.org/diabetes-basics/statistics/?referrer=https://www.google.com/
3Based on the sensor being replaced once every 10 days, and scanned at least once every 8 hours
4The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor
5Data on File. Abbott Diabetes Care.
6FreeStyle Libre User Manual.
7Fingersticks 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
8Bolinder, 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
9Haak, 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





 

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.