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  • Title: The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes.
    Author: Wilson DM, Beck RW, Tamborlane WV, Dontchev MJ, Kollman C, Chase P, Fox LA, Ruedy KJ, Tsalikian E, Weinzimer SA, DirecNet Study Group.
    Journal: Diabetes Care; 2007 Jan; 30(1):59-64. PubMed ID: 17192334.
    Abstract:
    OBJECTIVE: To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS: In 30 children with type 1 diabetes (mean age 11.2 +/- 4.1 years), the Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory using a hexokinase enzymatic method and in an outpatient setting with a FreeStyle meter. Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs. RESULTS: The median AD and RAD were 17 mg/dl and 12%, respectively, for 1,811 inpatient sensor-reference pairs and 20 mg/dl and 14%, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13%. Ninety-one percent of sensors in the inpatient setting and 81% of sensors in the outpatient setting had a median RAD < or = 20%. CONCLUSIONS: The Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.
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