Date: March 08, 2012
Alameda, California — Abbott (NYSE: ABT) today announced that it has received U.S. Food and Drug Administration (FDA) clearance for the FreeStyle InsuLinx Blood Glucose Monitoring System,[i] the first from Abbott to include a touch-screen interface, automated logbook and several personalization features designed to improve the diabetes management experience for patients. This unique device is also equipped with built-in FreeStyle Auto-Assist software that enables patients to track progress, analyze trends and easily display data for their health care providers. The FreeStyle InsuLinx System will be available to U.S. consumers within the coming months.
According to the American Diabetes Association (ADA), approximately 25.8 million people in the United States have diabetes,[ii] and of those, many require insulin to manage their condition. The FreeStyle InsuLinx System is the newest addition to Abbott’s portfolio of glucose monitoring systems and is designed to use FreeStyle technology to help insulin-using patients monitor their blood glucose levels to allow them to more effectively manage their condition. Specifically, the FreeStyle InsuLinx System offers:
The new FreeStyle InsuLinx blood glucose monitor includes an automated logbook, easy-to-use touch screen and personalization features.
The FreeStyle InsuLinx System is compatible with the FreeStyle InsuLinx blood glucose test strips.
"The new FreeStyle InsuLinx System represents Abbott’s latest advancement in delivering innovative products for people with diabetes who use insulin," said Heather L. Mason, senior vice president, Abbott Diabetes Care. "The improved functionality, data sharing tools and personalization features are designed to improve the diabetes management experience for patients. We are excited to make this product available to diabetes patients in the United States."
Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at www.abbottdiabetescare.com.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionally, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
[i] FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions.
[ii] American Diabetes Association: http://www.diabetes.org/diabetes-basics/diabetes-statistics/
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Although accurate and convenient for detecting type 2 diabetes and prediabetes in adults, current HbA1c cutoffs may not be enough to diagnose diabetes in children.
A 2010 clinical practice guideline from the American Diabetes Association recommends that physicians exclusively use the HbA1c assay to detect diabetes. The guidelines recommend a cutoff of 6.5% or greater for diagnosis.
However, researchers for two recent studies highlight significant vulnerabilities in the recommended test’s ability to diagnose diabetes and prediabetes in children.