WASHINGTON — Abbott recently announced the results from two new studies designed to assess the accuracy, safety and efficacy of the FreeStyle Navigator™ Continuous Glucose Monitoring System for children and adults. Both studies were presented during 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® 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.
“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 proved 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 more than 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. Points in the A zone are clinically accurate and most consistent with the lab reference value. B zone readings are clinically acceptable.
“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.
Abbott Diabetes Care, based in Alameda, Calif., is a developer, manufacturer and marketer of glucose monitoring systems designed to help patients better manage their diabetes. For more information, visit www.abbottdiabetescare.com.
