Accuracy of a blood glucose monitoring system at hypoglycaemic glucose levels: analysis of seven clinical studies

Background and aims: For individuals with diabetes detection of hypoglycemia is crucial, and blood glucose monitoring systems (BGMSs) must therefore be accurate in hypoglycemic ranges. Collecting sufficient data at low blood glucose (BG) levels is difficult; which may explain why evidence of BGMS performance during hypoglycemia is lacking. This analysis evaluated the accuracy of 5 performance-equivalent BGMSs using OneTouch® Verio® test strips at BG levels of < 3.9 mmol/L (70 mg/dL) in 7 separate clinical studies. Materials and methods: The studies were conducted between June 2009 and June 2011. BG testing was performed by trained staff in 2 clinical centers in the UK. All studies were conducted in accordance with standard ISO 15197:2003 testing guidelines. Each study included 100 participants with diabetes. For each participant, duplicate BGMS tests were performed using 3-4 test strip lots per study. BG reference values were obtained using a YSI 2300 STAT Glucose Analyzer before and after BGMS testing. Results: Of a total of 5,400 measurements, 674 (12.5%) were at a BG level of < 3.9 mmol/L (70 mg/dL). The number and percentage of results within ± 0.83 mmol/L (15 mg/dL) and ± 0.56 mmol/L (10 mg/dL) were calculated at BG levels < 3.9 mmol/L (70 mg/dL), < 3.3 mmol/L (60 mg/dL), and < 2.8 mmol/L (50 mg/dL). Accuracy of the OneTouch Verio test strips at hypoglycemic blood glucose levels are shown in the Table. Conclusion: Compared with analysis based on a single study, using data from 7 studies, 5 BGMSs, and 15 different test strip lots provides a robust depiction of test strip accuracy at BG levels < 3.9 mmol/L (70 mg/dL). The results indicate that OneTouch Verio test strips are highly accurate in the hypoglycemic range. Table. OneTouch Verio accuracy at BG levels < 3.9 mmol/L (70 mg/ dL).