A study published recently in the Journal of Diabetes Science and Technology (JDST) evaluated the accuracy of commercial blood glucose test strip platforms for patients with diabetes.1 In the report, the authors highlighted the clinical accuracy of OneTouch Select Plus blood glucose test strips.2

The study used approximately 21,000 data points from more than 200 different OneTouch Select Plus test strip batches, routinely and regularly sampling across 3 years of production to assess product accuracy, according to the manufacturer's press release.2 Investigators evaluated the test strips with a minimum of 100 subjects with diabetes, and then compared the readings with capillary blood samples collected at the same time.1

The study found that 97.6% of the batches met the accuracy criterion of 97.1-98.1% by year. The product also demonstrated clinical accuracy across all 7 glucose ranges. Under combined conditions of hematocrit and glucose extremes, 97.7% of values were clinically accurate.2

"In this study, results are based on more than 21,000 blood glucose meter readings gathered in a clinical setting and paired against corresponding reference instrument readings – all using OneTouch Select Plus test strips – over a period of years,” said Guido Freckman, MD, medical director of the Insitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, in a prepared statement.2 “This sort of continuous, systematic testing methodology enhances the picture of performance given by other accuracy studies, including those I have authored."

This is not the first time that researchers have tested OneTouch products. In both an April 2017 study and a March 2018 JDST study, experts tested the OneTouch Verio Flex platforms and found consistent high accuracy.2

According to the authors of the most recent study, due to publication of sometimes-conflicting data presented within ad hoc blood glucose monitoring clinical accuracy evaluations, they recommend that manufacturers adopt similarly robust and systematic surveillance programs to better safeguard patients.1


References
  1. Setford, S., Phillips, S., Grady, M. Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip. Journal of Diabetes Science and Technology. https://doi.org/10.1177/1932296819826968. Published February 7, 2019. Accessed February 12, 2019.
  2. Lifescan, Inc. OneTouch Blood Glucose Monitoring System Accuracy Proven in New Long-Term Study [news release]. Chesterbrook, Pennsylvania; February 8, 2019: Lifescan. https://www.prnewswire.com/news-releases/onetouch-blood-glucose-monitoring-system-accuracy-proven-in-new-long-term-study-300791765.html. Accessed February 12, 2019.