![]() ISO 15197:2013 accuracy blood glucose monitoring system mobile app self-monitoring of blood glucose. The BGMS exceeded ISO 15197:2013 accuracy criteria in the laboratory and in a clinical setting. Questionnaire results indicated that most subjects considered the system easy to use. Moreover, 97.6% (321/329) of subject self-test results were within ☑0 mg/dl (☐.6 mmol/L) or ☑0% of the YSI reference result. In the clinical study, among subjects with diabetes, 99.4% (327/329) of subject self-test results, 99.7% (331/332) of results obtained by study staff, 97.2% (309/318) of subject palm results, and 100% (330/330) of venous results met ISO 15197:2013 Section 8 accuracy criteria. ![]() 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. A questionnaire was provided to assess user feedback on ease of use. Alternate site tests and venipunctures were also performed for analysis. Each subject performed a self-test using the BGMS, which was repeated by a site staff member. Kit contains: Contour Next One blood glucose meter. Subjects with (n = 333) or without (n = 43) diabetes and who had not used the BGMS previously were enrolled. Details: For self-testing, monitoring, and management of blood glucose. A clinical study assessed accuracy per ISO 15197:2013 Section 8 criteria. The Contour Next One is measured to deliver an incredible 8.4, so exceeding industry standards, meaning you can be more confident than you have ever been in. 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.Ī 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.
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