Clinical assessment of the accuracy of blood glucose measurement devices

Abstract

Objectives:

Blood glucose meters for patient self-measurement need to comply with the accuracy standards of the ISO 15197 guideline. We investigated the accuracy of the two new blood glucose meters BG*Star and iBG*Star (Sanofi-Aventis) in comparison to four other competitive devices (Accu-Chek Aviva, Roche Diagnostics; FreeStyle Freedom Lite, Abbott Medisense; Contour, Bayer; OneTouch Ultra 2, Lifescan) at different blood glucose ranges in a clinical setting with healthy subjects and patients with type 1 and type 2 diabetes. BGStar and iBGStar are employ dynamic electrochemistry, which is supposed to result in highly accurate results.

Methods:

The study was performed on 106 participants (53 female, 53 male, age (mean ± SD): 46 ± 16 years, type 1: 32 patients, type 2: 34 patients, and 40 healthy subjects). Two devices from each type and strips from two different production lots were used for glucose assessment (∼200 readings/meter). Spontaneous glucose assessments and glucose or insulin interventions under medical supervision were applied to perform measurements in the different glucose ranges in accordance with the ISO 15197 requirements. Sample values <50 mg/dL and >400 mg/dL were prepared by laboratory manipulations. The YSI glucose analyzer (glucose oxidase method) served as the standard reference method which may be considered to be a limitation in light of glucose hexokinase-based meters.

Results:

For all devices, there was a very close correlation between the glucose results compared to the YSI reference method results. The correlation coefficients were r = 0.995 for BGStar and r = 0.992 for iBGStar (Aviva: 0.995, Freedom Lite: 0.990, Contour: 0.993, Ultra 2: 0.990). Error-grid analysis according to Parkes and Clarke revealed both 100% of the readings to be within the clinically acceptable areas (Clarke: A + B with BG*Star (100 + 0), Aviva (97 + 3), and Contour (97 + 3); and 99.5% with iBG*Star (97.5 + 2), Freedom Lite (98 + 1.5), and Ultra 2 (97.5 + 2)).

Conclusions:

This study demonstrated the very high accuracy of BG*Star, iBG*Star, and the competitive blood glucose meters in a clinical setting.

Keywords::

• Accuracy
• Blood glucose meter
• Dynamic electrochemistry
• Patient self-testing

Transparency

Declaration of funding

This study was funded by Sanofi-Aventis. A.P. wrote the manuscript, collected and interpreted the data and performed the laboratory measurements. M.M., P.B.M., D.S. and T.F. contributed to data collection, laboratory assessments and the results discussion. M.B. and A.Y. supervised the study conduct, analyzed the data and contributed to the discussion.

Declaration of financial/other relationships

A.P. and T.F. received speakers’ fees, consultancy fees, research grants and travel support from Sanofi, Abbott Medisense, NovaBiomedical, Roche Diagnostics, and Bayer. P.B.M. received speakers’ fees and travel support from Sanofi. M.M., D.S., M.B. and A.Y. have no conflict of interest to declare.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors would like to thank the patients, physicians and nurses at IKFE Clinic, the scientists and laboratory assistants at IKFE Laboratory, and the Clinical Research Staff at IKFE-CRO who contributed to the successful performance of this study.