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Diabetes Res. Clin. Pract. · Dec 2012
Clinical evaluation of a novel test strip technology for blood glucose monitoring: accuracy at hypoglycaemic glucose levels.
- Srikanth Bellary, Hillary Cameron, Kirsty Macleod, Michael Malecha, Krisna Koria, Praveen Raja, Jesús Diago Cabezudo, and John Ellison.
- Aston Research Centre for Healthy Ageing, Aston University, Birmingham, UK. s.bellary@aston.ac.uk
- Diabetes Res. Clin. Pract. 2012 Dec 1; 98 (3): 430-5.
AimTo evaluate OneTouch® Verio™ test strip performance at hypoglycaemic blood glucose (BG) levels (<3.9 mmol/L [<70 mg/dL]) at seven clinical studies.MethodsTrained clinical staff performed duplicate capillary BG monitoring system tests on 700 individuals with type 1 and type 2 diabetes using blood from a single fingerstick lancing. BG reference values were obtained using a YSI 2300 STAT™ Glucose Analyzer. The number and percentage of BG values within ±0.83 mmol/L (±15 mg/dL) and ±0.56 mmol/L (±10 mg/dL) were calculated at BG concentrations of <3.9 mmol/L (<70 mg/dL), <3.3 mmol/L (<60 mg/dL), and <2.8 mmol/L (<50 mg/dL).ResultsAt BG concentrations <3.9 mmol/L (<70 mg/dL), 674/674 (100%) of meter results were within ±0.83 mmol/L (±15 mg/dL) and 666/674 (98.8%) were within ±0.56 mmol/L (±10 mg/dL) of reference values. At BG concentrations <3.3 mmol/L (<60 mg/dL), and <2.8 mmol/L (<50 mg/dL), 358/358 (100%) and 270/270 (100%) were within ±0.56 mmol/L (±10 mg/dL) of reference values, respectively.ConclusionIn this analysis of data from seven independent studies, OneTouch Verio test strips provide highly accurate results at hypoglycaemic BG levels.Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
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