T. Bailey, Anna Chang, P. Rosenblit
Aug 1, 2012
Citations
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Influential Citations
15
Citations
Quality indicators
Journal
Diabetes technology & therapeutics
Abstract
BACKGROUND OneTouch® Verio™ test strips (LifeScan Inc., Milpitas, CA) are designed to minimize error when used in blood glucose monitoring systems. These strips have a specialized architecture and incorporate a sophisticated waveform and proprietary algorithm. MATERIALS AND METHODS Performance of OneTouch Verio test strips was assessed in the laboratory in the presence of a wide range of patient, environmental, and pharmacologic factors. A clinical evaluation was conducted in which 296 patients and healthcare professionals (HCPs) performed glucose testing using OneTouch Verio test strips and OneTouch VerioIQ meters. RESULTS In the laboratory study, OneTouch Verio test strip results achieved a high level of performance over a wide range of hematocrit (19-61%), temperature (5-45(°)C), humidity (10-90% relative humidity), and altitude (0-3,048 m) conditions. Performance was not affected by 22 of 23 chemical compounds. In the clinical study, 100% (31/31) of lay-user test results were within ±10 mg/dL of reference values for blood glucose <75 mg/dL. At blood glucose ≥75 mg/dL, 99.2% (243/245) were within ±15% of reference values. A feature of the VerioIQ meter, PatternAlert(™) Technology, was correctly used and positively evaluated by >98% of lay users. CONCLUSIONS OneTouch Verio test strips are accurate and precise over a wide range of patient, environmental, and pharmacologic conditions. In addition, lay-users were able to successfully use the OneTouch VerioIQ PatternAlert Technology without HCP training.