{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T22:15:26Z","timestamp":1783462526309,"version":"3.55.0"},"reference-count":28,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2018,12,14]],"date-time":"2018-12-14T00:00:00Z","timestamp":1544745600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"ForaCare Suisse AG"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Analytical quality of blood glucose monitoring systems (BGMS) is an important aspect for many diabetes patients. Sufficiently high analytical quality is required for adequate diabetes therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>In this study, system accuracy and measurement precision of a BGMS were assessed based on ISO 15197:2013. For system accuracy, this standard requires a specific glucose distribution and at least 95% of results obtained with the BGMS in capillary blood to fall within \u00b115 mg\/dl or \u00b115% (at glucose concentrations &lt;100 mg\/dl or \u2265100 mg\/dl, respectively) of corresponding comparison method results, and at least 99% of results to be found within clinically acceptable consensus error grid (CEG) zones A and B. Based on ISO 15197:2013, intermediate measurement precision, using control solution, and measurement repeatability, using venous blood samples, were analyzed by calculation of standard deviations (SDs) and coefficients of variation (CV) at glucose concentrations &lt;100 mg\/dl or \u2265100 mg\/dl, respectively, although ISO 15197:2013 does not specify acceptance criteria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The BGMS fulfilled system accuracy requirements with \u226599% of results within \u00b115 mg\/dl or \u00b115% of the comparison method results, and 100% of results in CEG zones A and B. Intermediate measurement precision analysis showed SD \u22642.2 mg\/dl and CV \u22642.3%. Analysis of measurement repeatability showed SD \u22642.1 mg\/dl and CV \u22642.4%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>System accuracy requirements of ISO 15197:2013 were fulfilled by the BGMS. As ISO 15197:2013 does not specify precision requirements, precision analysis results were compared with those reported for other BGMS in the literature and found to be similar.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1932296818821105","type":"journal-article","created":{"date-parts":[[2018,12,14]],"date-time":"2018-12-14T11:24:45Z","timestamp":1544786685000},"page":"235-241","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197"],"prefix":"10.1177","volume":"13","author":[{"given":"Nina","family":"Jendrike","sequence":"first","affiliation":[{"name":"Institut f\u00fcr Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universit\u00e4t Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette","family":"Baumstark","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universit\u00e4t Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4629-7754","authenticated-orcid":false,"given":"Stefan","family":"Pleus","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universit\u00e4t Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Mende","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universit\u00e4t Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"Haug","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universit\u00e4t Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0406-9529","authenticated-orcid":false,"given":"Guido","family":"Freckmann","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universit\u00e4t Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,12,14]]},"reference":[{"key":"bibr1-1932296818821105","unstructured":"International Organization for Standardization. In vitro diagnostic test systems\u2014requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013. 2013. Geneva, Switzerland: International Organization for Standardization; 2013."},{"key":"bibr2-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1177\/193229681300700627"},{"key":"bibr3-1932296818821105","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.8.1143"},{"key":"bibr4-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(86)90837-8"},{"key":"bibr5-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1177\/1932296814539589"},{"key":"bibr6-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1177\/1932296814539590"},{"key":"bibr7-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1177\/193229681200600511"},{"key":"bibr8-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1177\/1932296815612496"},{"key":"bibr9-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2005.049080"},{"key":"bibr10-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1586\/17434440.2015.1019469"},{"key":"bibr11-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2015-0130"},{"key":"bibr12-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.21947"},{"key":"bibr13-1932296818821105","doi-asserted-by":"publisher","DOI":"10.1177\/1932296818804837"},{"key":"bibr14-1932296818821105","unstructured":"US Food and Drug Administration. Self-Monitoring blood glucose test systems for over-the-counter use\u2014guidance for industry and food and drug administration Staff. Rockville, MD: US Food and Drug Administration. 2016; Available at: http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM380327.pdf. Accessed December 8, 2018."},{"key":"bibr15-1932296818821105","unstructured":"SKUP. Scandinavian evaluation of laboratory equipment for point of care testing. Quality goals in SKUP evaluations. 2018; Available at: https:\/\/skup.org\/visartikkel.aspx?id=48. 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