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.

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PID https://www.doi.org/10.6084/m9.figshare.11567313.v1
PID https://www.doi.org/10.6084/m9.figshare.11567313
PID https://www.doi.org/10.1080/17434440.2020.1704253
URL https://www.ncbi.nlm.nih.gov/pubmed/31825686
URL http://dx.doi.org/10.6084/m9.figshare.11567313
URL http://dx.doi.org/10.6084/m9.figshare.11567313.v1
URL https://academic.microsoft.com/#/detail/2994924405
URL http://dx.doi.org/10.1080/17434440.2020.1704253
URL https://www.tandfonline.com/doi/pdf/10.1080/17434440.2020.1704253
URL https://www.tandfonline.com/doi/abs/10.1080/17434440.2020.1704253
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Access Right Open Access
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Author Bern Harrison
Author Daniel Brown
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Collected From Datacite; figshare; Crossref; Microsoft Academic Graph
Hosted By Expert Review of Medical Devices; figshare
Publication Date 2020-01-01
Publisher Taylor & Francis
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Language UNKNOWN
Resource Type Other literature type; Article
keyword FOS: Chemical sciences
keyword FOS: Health sciences
keyword FOS: Biological sciences
system:type publication
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Source https://science-innovation-policy.openaire.eu/search/publication?articleId=dedup_wf_001::77a79bf704350b720a59c7f49be5ee50
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Last Updated 27 December 2020, 02:49 (CET)
Created 27 December 2020, 02:49 (CET)