The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes.
OBJECTIVE
To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes.


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.
Wilson
Darrell M
DM
DirecNet Coordinating Center, Jaeb Center for Health Research, 15310 Amberly Dr., Suite 350, Tampa, FL 33647, USA. direcnet@jaeb.org
Beck
Roy W
RW
Tamborlane
William V
WV
Dontchev
Mariya J
MJ
Kollman
Craig
C
Chase
Peter
P
Fox
Larry A
LA
Ruedy
Katrina J
KJ
Tsalikian
Eva
E
Weinzimer
Stuart A
SA
D000293:Adolescent; D001786:Blood Glucose / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D005080:Exercise Test; D005260:Female; D006801:Humans; D007297:Inpatients; D008297:Male; D018670:Monitoring, Ambulatory / Q000592:standards*; D010045:Outpatients; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D001786:Blood Glucose