FREESTYLE LIBRE 14 DAY, NOW FDA APPROVED

Abbott's flash glucose monitor now FDA-approved for two weeks of use in U.S. between sensor changes.

Abbott Tech 101

The U.S. Food and Drug Administration has approved FreeStyle Libre 14 day — Abbott's revolutionary continuous glucose monitoring system. In the U.S., you can wear the sensor up to 14 days with high accuracy.

For people living with diabetes and doing the hard work to maintain healthy glucose levels while focusing on ways to lower their blood sugar — all without painful fingersticks or being tied a bulky continuous glucose monitor — FreeStyle Libre 14 day is a life-changing technology.

Beyond saving patients pain from sticking their fingers up to 10 times a day1, the system provides people living with diabetes with three key pieces of data with each scan:

  • Real-time glucose result.
  • An 8-hour historical trend.
  • And a trend arrow showing the direction their glucose is going.

With this data at their fingertips, the FreeStyle Libre 14 day system is helping improve patient outcomes. It's the future people living with diabetes have been hoping for.

With this FDA approval, the FreeStyle Libre 14 day system is the longest lasting self-applied personal glucose sensor available on the market.

"People with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition," said Jared Watkin, senior vice president, Diabetes Care.

Data from FreeStyle Libre can be shared with doctors and healthcare providers. Along with smart diabetes nutrition, patients can devise the most effective treatment plan for their lives.

Around the globe, FreeStyle Libre is helping people living with diabetes achieve their best lives. From the routine of everyday to running marathons, they're no longer slowed by diabetes management as they were before.

No wonder the system has been honored among the most innovative creations at a company full of them. Don’t take our word for it. That's from Fast Company. Want a behind-the-scenes look at FreeStyle Libre? Come on in.

The FreeStyle Libre 14 day system will be available via prescription in coming months at participating pharmacies and durable medical equipment suppliers in the U.S. For more information about how FreeStyle Libre can help you, please click here.

 

Indications and Important Safety Information

FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices 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 systems are intended for single patient use and require 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 systems do not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The systems are 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. For full indications for use and safety information, see more here.

1. American Diabetes Association Standards of medical care in diabetes 2014. Diabetes Care January 2014, v37 suppl1 s21-22

 

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