Journal
DIABETES CARE
Volume 30, Issue 1, Pages 59-64Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc06-1407
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Funding
- NCRR NIH HHS [M01 RR006022, RR00070-41, RR00059, M01 RR000070, RR 06022, M01 RR000069, M01 RR000059, M01 RR00069] Funding Source: Medline
- NICHD NIH HHS [U10 HD041906, U10 HD041908, U10 HD041915, U01 HD041890, U10 HD041919, HD041919-01, U10 HD041918, HD041908-01, HD041918-01, HD041915-01, HD041890, HD041906-01, U10 HD041890] Funding Source: Medline
- EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH &HUMAN DEVELOPMENT [U01HD041890, U10HD041918, U10HD041906, U10HD041919, U10HD041915, U10HD041908, U10HD041890] Funding Source: NIH RePORTER
- NATIONAL CENTER FOR RESEARCH RESOURCES [M01RR006022, M01RR000059, M01RR000069, M01RR000070] Funding Source: NIH RePORTER
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OBJECTIVE - To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type I diabetes. RESEARCH DESIGN AND METHODS - in 30 children with type I 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 <= 20%. CONCLUSIONS - The Navigator's accuracy does not yet approach the accuracy of currentgeneration 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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