A New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device: Accuracy and User Performance Evaluation
| Autor: | Timothy S. Bailey, Mary Ellen Warchal-Windham, Mark P. Christiansen, Bern Harrison, Scott Pardo, Robert Morin, Carmine Greene |
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| Rok vydání: | 2017 |
| Předmět: |
Blood glucose monitoring
medicine.medical_specialty medicine.diagnostic_test Computer science business.industry Endocrinology Diabetes and Metabolism Biomedical Engineering Mobile apps 030209 endocrinology & metabolism Bioengineering Clinical study 03 medical and health sciences 0302 clinical medicine Internal Medicine medicine Wireless Medical physics 030212 general & internal medicine business Mobile device User feedback Computer hardware |
| Zdroj: | Journal of Diabetes Science and Technology. 11:567-573 |
| ISSN: | 1932-2968 |
| Popis: | Background:These studies investigated the accuracy of the new Contour®Next ONE blood glucose monitoring system (BGMS) that is designed to sync with the Contour™ Diabetes app on a smartphone or tablet.Methods:A laboratory study tested fingertip capillary blood samples from 100 subjects in duplicate using 3 test strip lots, based on ISO 15197:2013 Section 6.3 analytical accuracy standards. A clinical study assessed accuracy per ISO 15197:2013 Section 8 criteria. Subjects with (n = 333) or without (n = 43) diabetes and who had not used the BGMS previously were enrolled. Each subject performed a self-test using the BGMS, which was repeated by a site staff member. Alternate site tests and venipunctures were also performed for analysis. A questionnaire was provided to assess user feedback on ease of use.Results:In the laboratory study, 100% (600/600) of combined results for all 3 test strip lots met ISO 15197:2013 Section 6.3 accuracy criteria. In the clinical study, among subjects with diabetes, 99.4% (327/329... |
| Databáze: | OpenAIRE |
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