Clinical evaluation of a novel test strip technology for blood glucose monitoring: accuracy at hypoglycaemic glucose levels.

Aim: To evaluate OneTouch® Verio™ test strip performance at hypoglycaemic blood glucose (BG) levels (<3.9 mmol/L [<70 mg/dL]) at seven clinical studies.

Methods: Trained 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).

Results: At 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.

Conclusion: In this analysis of data from seven independent studies, OneTouch Verio test strips provide highly accurate results at hypoglycaemic BG levels.