Abbott's FreeStyle Navigator Continuous Glucose Monitoring System meets study endpoints

By Lisa Kerner

Charlotte, N.C., June 12 - Abbott said two new studies met the predefined endpoints designed to assess the accuracy, safety and efficacy of the FreeStyle Navigator Continuous Glucose Monitoring System for children and adults.

The investigational device includes a five-day sensor, a transmitter and a wireless receiver with a built-in FreeStyle blood glucose monitoring system designed to provide glucose readings once per minute, high/low glucose alarms and projected glucose alarms.

A National Institutes of Health-funded DirecNet trial of 30 children ages four to 17 in both inpatient and outpatient settings showed the FreeStyle Navigator system sustained accuracy and precision for five days of wear in different insertion locations (arm, abdomen or hip), during exercise and after meals.

"FreeStyle Navigator has proven to be highly accurate in clinical studies to date," Abbott Diabetes Care president Ed Fiorentino said in a company news release.

"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."

A second study evaluated the FreeStyle Navigator system in home use for 40 days by 123 type 1 and type 2 diabetes subjects.

Performance was evaluated by comparing more than 11,000 values obtained from the system and simultaneous pairs of blood glucose values.

In a Clarke Error Grid analysis, 96.8% of blood glucose values fell in the clinically accurate or clinically acceptable zones: zone A or zone B.

Both studies will be presented during poster sessions at the 66th annual Scientific Sessions of the American Diabetes Association.

Abbott Diabetes Care, based in Alameda, Calif., develops, manufactures and markets glucose monitoring systems.

Chicago-based Abbott develops pharmaceutical and medical products, including nutritionals, devices and diagnostics.

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