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

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.