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Diabetes Care ; 30(1): 59-64, 2007 Jan.
Article in English | MEDLINE | ID: mdl-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.


Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 1/blood , Monitoring, Ambulatory/standards , Adolescent , Child , Child, Preschool , Exercise Test , Female , Humans , Inpatients , Male , Outpatients , Reproducibility of Results , Sensitivity and Specificity
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