A Multicenter Study of the Accuracy of the One Touch® Ultra® Home Glucose Meter in Children with Type 1 Diabetes

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  • TGThe Diabetes Research In Children Network (Direcnet) Study Group
    The Diabetes Research In Children Network (Direcnet) Study Group
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Abstract
Data are not readily available on the accuracy of one of the most commonly used home blood glucose meters, the One Touch® Ultra® (LifeScan, Milpitas, California). The purpose of this report is to provide information on the accuracy of this home glucose meter in children with type 1 diabetes. During a 24-h clinical research center stay, the accuracy of the Ultra meter was assessed in 91 children, 3–17 years old, with type 1 diabetes by comparing the Ultra glucose values with concurrent reference serum glucose values measured in a central laboratory. The Pearson correlation between the 2,068 paired Ultra and reference values was 0.97, with the median relative absolute difference being 6%. Ninety-four percent of all Ultra values (96% of venous and 84% of capillary samples) met the proposed International Organisation for Standardisation (ISO) standard for instruments used for self-monitoring of glucose when compared with venous reference values. Ninety-nine percent of values were in zones A + B of the Modified Error Grid. A high degree of accuracy was seen across the full range of glucose values. For 353 data points during an insulin-induced hypoglycemia test, the Ultra meter was found to have accuracy that was comparable to concurrently used benchmark instruments (Beckman, YSI, or i-STAT); 95% and 96% of readings from the Ultra meter and the benchmark instruments met the proposed ISO criteria, respectively. These results confirm that the One Touch Ultra meter provides accurate glucose measurements for both hypoglycemia and hyperglycemia in children with type 1 diabetes.

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