FDA Approves Freestyle Connect(R) Blood Glucose Monitoring System, Abbott

Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics
Article Date: 22 Aug 2005 - 0:00 PDT

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Abbott Diabetes Care, a division of Abbott, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FreeStyle Connect(R) blood glucose monitoring system in the point-of-care setting (hospitals and medical clinics).

FreeStyle Connect measures glucose levels using a very small blood sample size (0.3 micro liter), the smallest sample size required of any point-of-care blood glucose monitoring product on the market. It is the also the fastest point-of-care blood glucose monitoring system available, providing results within an average of 15 seconds. The advanced technology employed by FreeStyle Connect ensures reliable results under real-world conditions, with accuracy independent of blood oxygen levels. Further, results are not affected by many common substances such as aspirin, acetaminophen, gentisic acid, uric acid, vitamins, and many over-the-counter drugs. FreeStyle Connect is also designed to seamlessly interface with any open point-of-care data management system.

"Studies have demonstrated that FreeStyle Connect provides accurate results using a very small sample size which may offer advantages with challenging arterial and neonatal samples. In addition, it may save nursing time, which is a key benefit in a busy hospital," said George Cembrowski, M.D., Ph.D, Associate Professor, Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta.

FreeStyle Connect uses a technology exclusive to all FreeStyle(R) meters based on coulometric measurement. This unique, patented, electrochemical technology measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. Coulometric technology has already been used by people with diabetes worldwide in more than two billion blood glucose tests using FreeStyle(R) blood glucose strips.

"FreeStyle Connect is an exciting advance for blood glucose monitoring in the point-of-care setting, offering outstanding accuracy. FreeStyle Connect also provides improved convenience and ease-of-use for clinicians and hospital staff," said Ed Fiorentino, President, Abbott Diabetes Care.

The accuracy of the FreeStyle Connect blood glucose monitoring system has been tested in three clinical studies1,2,3. Two studies conducted at Duke University Medical Center and Hartford Hospital, examined nearly 300 arterial blood samples comparing FreeStyle Connect to three laboratory analyzers. The Duke study found that FreeStyle Connect provided accurate, rapid results on a very small volume of blood in the point-of-care setting. The Hartford researchers concluded that FreeStyle Connect results were consistent with laboratory assays and were not affected by hemoglobin and oxygen in the arterial blood samples.1,2

The third study, conducted at Washington University School of Medicine, evaluated the accuracy of FreeStyle Connect in 194 blood samples from neonates less than 10 days old. The results demonstrated accuracy as compared to the laboratory method. The researchers also found this monitoring system useful in neonates due to the very small blood sample required for testing.3

FreeStyle Connect blood glucose monitoring systems will be available in August, 2005.

About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help patients better manage their diabetes. Abbott Diabetes Care is committed to developing products to reduce the discomfort and inconvenience of blood glucose monitoring and introducing systems that are easier to use, require smaller blood samples and provide faster results.

Abbott Diabetes Care manufactures and markets several leading-edge glucose monitoring systems and test strips in the United States for use in both home and hospital settings; leading brands include FreeStyle,(R) FreeStyle Flash(R), and Precision Xtra.(R) Additional information about Abbott Diabetes Care can be found at http://www.abbottdiabetescare.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.

1 Toffaletti, J, McDonnell E. Evaluation of a coulometric hand-held blood glucose monitoring device. Duke University Medical Center.

2 Wu A, Smith A. Arterial blood testing using the FreeStyle Blood Glucose Monitoring System. Hartford Hospital.

3 Dietzen, DJ, Wilhite TR, Accuracy of near-patient glucose analysis using coulometry in neonates. Department of Pediatrics, Washington University School of Medicine, St. Louis Children's Hospital.

http://www.abbottdiabetescare.com