Freckmann, Guido Mende, Jochen Pleus, Stefan Waldenmaier, Delia Baumstark, Annette Jendrike, Nina Haug, Cornelia
Published in
Journal of diabetes science and technology
The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO ...
Baumstark, Annette Liebing, Christina Jendrike, Nina Pleus, Stefan Haug, Cornelia Freckmann, Guido
Published in
Journal of Diabetes Science and Technology
Pardo, Scott Shaginian, Rimma M Simmons, David A
Published in
Journal of diabetes science and technology
Diabetes treatment is intended to maintain near-normal glycemic levels. Self-monitoring of blood glucose (SMBG) allows patients to track their BG levels compared with glycemic targets and is associated with improved health outcomes. Because of the importance of SMBG, it is essential that results are accurate to prevent errors in nutritional intake ...
Baumstark, Annette Jendrike, Nina Liebing, Christina Haug, Cornelia Freckmann, Guido
Published in
Journal of diabetes science and technology
An improved test cassette for the integrated Accu-Chek® Mobile system (Roche Diabetes Care GmbH, Mannheim, Germany) has been developed. System accuracy of this improved system was evaluated based on ISO 15197:2013, clause 6.3, for three reagent system lots. According to this standard, at least 95% of the system's measurement results shall be within...
Baumstark, Annette Jendrike, Nina Pleus, Stefan Liebing, Christina Haug, Cornelia Freckmann, Guido
Published in
Journal of diabetes science and technology
Hattemer, Andrew Wardat, Sami
Published in
Journal of Diabetes Science and Technology
Introduction: ISO 15197:2013 recommends testing procedures and acceptance criteria for the evaluation of influence quantities such as hematocrit on measurement results with systems for self-monitoring of blood glucose (SMBG). In this study, hematocrit influence was evaluated for a novel SMBG system (system A) and five other systems with different h...
Jendrike, Nina Baumstark, Annette Chen, Chieh-Hsiao Rittmeyer, Delia Haug, Cornelia Freckmann, Guido
Published in
Journal of diabetes science and technology
The novel system for self-monitoring of blood glucose (SMBG) PixoTest couples SMBG to a smartphone and does not require a separate glucose meter. The integrated system includes all components necessary for a glucose measurement, and owing to a colorimetric measurement principle, a smartphone camera can capture color changes and a software app calcu...
Bailey, Timothy S Wallace, Jane F Pardo, Scott Warchal-Windham, Mary Ellen Harrison, Bern Morin, Robert Christiansen, Mark
Published in
Journal of diabetes science and technology
The new Contour®Plus ONE blood glucose monitoring system (BGMS) features an easy-to-use, wireless-enabled blood glucose meter that links to a smart mobile device via Bluetooth® connectivity and can sync with the Contour™ Diabetes app on a smartphone or tablet. The accuracy of the new BGMS was assessed in 2 studies according to ISO 15197:2013 criter...
Christiansen, Mark Greene, Carmine Pardo, Scott Warchal-Windham, Mary Ellen Harrison, Bern Morin, Robert Bailey, Timothy S
Published in
Journal of diabetes science and technology
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. 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 analytic...
Grant, Danielle A Dunseath, Gareth J Bain, Stephen C Luzio, Stephen
Published in
Journal of diabetes science and technology
