Accuracy of a blood glucose monitoring system that recognizes insufficient sample blood volume and allows application of more blood to the same test strip

ABSTRACT

Background: Self-monitoring of blood glucose (SMBG) can play a key role in diabetes management. The CONTOUR®NEXT ONE (Ascensia Diabetes Care, Parsippany, NJ, USA) blood glucose monitoring system (BGMS) has been developed for use with CONTOUR®NEXT test strips. The meter connects to the CONTOUR™ Diabetes application on a mobile device, and the Second-Chance® sampling feature recognizes insufficient sample volume, prompting the patient to apply more blood to the same strip if needed (sample re-application).

Research design and methods: Two studies evaluated CONTOUR®NEXT ONE BGMS accuracy with sample re-application: a laboratory study (performance under various controlled conditions) and a clinical study (performance in the hands of 52 people with diabetes). A formal International Organization for Standardization (ISO) evaluation has been reported previously; here, accuracy criteria in the laboratory and clinical studies were aligned with ISO 15197:2013 sections 6.3.3 and 8.2, respectively.

Results: All results under all conditions in the laboratory study, and with glucose concentrations <100 and ≥100 mg/dL in the clinical study, were within ±15 mg/dL or ±15% of reference measurements. In both studies, all results were within Zone A of the Parkes-Consensus Error Grid.

Conclusions: These data demonstrate that the accuracy of the CONTOUR®NEXT ONE BGMS was maintained with sample re-application.

KEYWORDS:

• Diabetes mellitus
• self-monitoring of blood glucose
• blood glucose meter
• accuracy
• test strips
• sample volume
• Second-Chance sampling
• sample re-application

Acknowledgments

These studies were supported by Bayer HealthCare, the predecessor-in-interest of Ascensia Diabetes Care, Parsippany, NJ, USA. The authors would like to thank Miho Takeshima, a former employee of Panasonic Healthcare Co. Ltd., for her contributions to the laboratory study. Medical writing assistance was provided by Allison Michaelis, PhD, of MedErgy and James Currie, PhD of CircleScience (an Ashfield Healthcare Communications company), and was funded in part by Ascensia Diabetes Care.

Author contributions

B Harrison was involved in the conception, design, analysis, and interpretation of the laboratory study; D Brown was involved in the conception and design of the clinical study.

Declaration of interest

B Harrison and D Brown are employees of Ascensia Diabetes Care. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary Material

Supplemental data for this article can be accessed here.

Additional information

Funding

This paper was funded by Bayer HealthCare, the predecessor-in-interest of Ascensia Diabetes Care. Medical writing support was part-funded by Ascensia Diabetes Care.