WASHINGTON, June 10 /PRNewswire-FirstCall/ -- Abbott announced today the presentation of results from two new studies that met the predefined endpoints designed to assess the accuracy, safety and efficacy of the FreeStyle Navigator(TM) Continuous Glucose Monitoring System for children and adults. Both studies will be presented during poster sessions beginning Saturday, June 10th, at the 66th annual Scientific Sessions of the American Diabetes Association.
The FreeStyle Navigator Continuous Glucose Monitoring System is an investigational device under FDA review. The system includes a five-day sensor, a transmitter, and a wireless receiver with a built-in FreeStyle(R) blood glucose monitoring system. The system is designed to provide glucose readings once per minute, high/low glucose alarms and projected glucose alarms.
Pediatric Accuracy Study - NIH DirecNet
In a National Institutes of Health (NIH) funded DirecNet trial of 30 children (ages 4 to 17) in both inpatient and outpatient settings, FreeStyle Navigator system accuracy and precision were sustained for five days of wear and were similar in different insertion locations (arm, abdomen or hip). In addition, accuracy of the FreeStyle Navigator system was similar during inpatient use and when used at home; and it was accurate during exercise and after meals. DirecNet will present the trial results in a poster (number 391-P) entitled, "Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System in Children with Type 1 Diabetes Mellitus."
"The need for frequent blood glucose monitoring remains a barrier to achieving excellent diabetes control -- an accurate, real-time continuous glucose system such as FreeStyle Navigator would provide valuable information for improved diabetes management," said Peter Chase, M.D., professor of pediatrics and clinical director emeritus of the Barbara Davis Center for Childhood Diabetes at the University of Colorado Health Sciences Center. "These data are promising and suggest the potential value of FreeStyle Navigator in the management of type 1 diabetes in both children and adults."
"FreeStyle Navigator has proven to be highly accurate in clinical studies to date," said Ed Fiorentino, president, Abbott Diabetes Care. "Based on the promising results obtained from the NIH DirecNet study, and via other clinical studies we hope to initiate, Abbott intends to file a supplemental PMA with the FDA for a pediatric indication in the post-approval period."
Performance During Home Use Study
In a second study, the safety and efficacy of the FreeStyle Navigator system was evaluated in the home use environment in 123 type 1 and type 2 diabetes subjects who completed the study. The data obtained from this trial were submitted to the U.S. Food and Drug Administration as part of Abbott's PMA for the FreeStyle Navigator system. The study was designed for a total of 40 days of sensor wear (arm or abdomen). Performance was evaluated through a comparison between over 11,000 values obtained from the FreeStyle Navigator system and simultaneous pairs of blood glucose values. The overall mean absolute relative difference in these values was 14.4 +/- 13.4 percent, and in a Clarke Error Grid (CEG) analysis, 96.8 percent of the values fell in zone A or zone B. The Clarke Error Grid compares readings from a lab reference to a reading from a glucose monitoring device at a specific point in time. The variance between the two readings is placed on a grid within clinical categories, also known as zones. Each zone is labeled A, B, C, D, or E. Points in the A zone are clinically accurate and most consistent with the lab reference value. B zone readings are clinically acceptable. Points in the C, D, and E zones are progressively less accurate.
"While not a primary endpoint, patients in this study spent significantly less time in hypoglycemic and hyperglycemic states during the unblinded phase of the trial," said Bruce Bode, M.D., medical director of Atlanta Diabetes Associates. For a person with diabetes, less time spent in either a hypo- or hyperglycemic state has been correlated with reduced risk for a number of serious, sometimes life-threatening complications. Study results will be presented in a poster (number 2-LB) entitled, "Performance of the FreeStyle Navigator Continuous Glucose Monitoring System During Home Use."
About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, Calif., 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 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(TM). Additional information about Abbott Diabetes Care may 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 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ .
