Abstract
Objective: Self-monitoring of blood glucose is a key element in diabetes management. Accurate and precise performance of blood glucose monitors (BGMs) ensures that valid values are obtained to guide treatment decisions by patients and physicians. BGStar and iBGStar are hand-held BGMs that use dynamic electrochemistry to correct for potential interferences and thereby minimize system errors.
Research design and methods: A single-center, in vitro diagnostic device performance evaluation with heparinized oxygenated venous blood samples (intra-assay precision) and control solutions (interassay precision) was performed in a laboratory setting, comparing BGStar and iBGStar with 12 competitors.
Main outcome measures: The primary outcome was the coefficient of variation percent (CV%) of the BGMs investigated.
Results: In inter-assay precision analyses, all but GlucoMen LX had a CV <5%, and in intra-assay precision analyses, 10 of the 14 devices tested had CV <5%. BGStar and iBGStar had a CV <5% in both the inter- and intra-assay precision analyses. The smallest variation was found in the near-normoglycemic glucose range (5.3 – 8.0 mmol/l) for both BGStar and iBGStar in the inter-assay precision analysis.
Conclusions: BGStar and iBGStar were proven to have very good inter-assay and high intra-assay precision, demonstrating low scattering of replicate measurements with both clinical samples and control solutions.
Acknowledgments
The contents of this paper and opinions expressed within are those of the authors, and it was the decision of all authors to submit the manuscript for publication. All authors contributed to the research of the data in this manuscript and all reviewed/edited the manuscript.
Declaration of interest
This study was sponsored by Sanofi-Aventis. Editorial support was provided by Alexander Jones, PhD, Medicus International, and was funded by Sanofi-Aventis. Authors have received speaker fees, travel support, study grants and/or consultant fees from Sanofi-Aventis and from several of the manufacturers of competitor devices assessed in this study as follows: Sanofi-Aventis (A Pfützner, PB Musholt, T Forst), Abbott (A Pfützner), LifeScan (A Pfützner, PB Musholt), Menarini (A Pfützner, PB Musholt), NovaBiomedical (A Pfützner, PB Musholt), Terumo (A Pfützner, PB Musholt) and Roche Diagnostics (A Pfützner, PB Musholt). F Flacke and J Sieber are employees of Sanofi-Aventis. C Schipper, S Ramljak and M Borchert have no conflicts of interest to declare.