According to the CDC, 30.3 million Americans (nearly 1 in 10) have diabetes, while 84.1 million American adults - approximately 1 in 3 - have pre-diabetes. Diabetes mellitus is always diagnosed by blood glucose tests performed in the central laboratory. Point-of-care analyzers are widely used to monitor patients with diabetes. FDA-approved portable glucose analyzers are used to analyze fingerstick capillary blood specimens to determine the dose of insulin. Diagnostic point-of-care testing (POCT) for diabetes provides results quickly, allowing clinicians to expedite therapeutic decisions.
Abbott Laboratories recently received approval from the Food and Drug Administration for its FreeStyle LibreLink diabetes-monitoring app, which provides users a way to keep track of their glucose levels from their iPhones. The Libre system replaces self-monitoring of diabetes on conventional pocket-sized blood sugar testing devices and eliminates the need for finger-pricking, except in special circumstances. Optional glucose alarms let Libre users know when their glucose levels are too high or too low.
Since February 2018, this FreeStyle LibreLink app has been available for Apple Inc.'s iPhone and Android devices in Europe, with more than 250,000 downloads. With a 37.4 percent increase in sales for the company's diabetes unit, this company's app has exceeded analyst's expectations. Service for U.S. Android devices is still under development.
Jared Watkin, Senior Vice President, Diabetes Care, Abbott, says, "The FreeStyle Libre 2 system is designed to further empower people with diabetes by providing a choice about how they want to use alarms - which can be a valuable feature for a specific group of people managing their diabetes. We're committed to developing the latest health technology to help people lead fuller lives. Our goal is to make FreeStyle Libre widely accessible, which includes offering additional features at no additional cost to our customers."
Data from this app can be shared with doctors and healthcare providers through digital health tools such as LibreView and LibreLinkUp.