{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T13:39:46Z","timestamp":1777556386800,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2011,9,1]],"date-time":"2011-09-01T00:00:00Z","timestamp":1314835200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2011,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>This study evaluated performance and product labeling of CONTOUR\u00ae USB, a new blood glucose monitoring system (BGMS) with integrated diabetes management software and a universal serial bus (USB) port, in the hands of untrained lay users and health care professionals (HCPs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method:<\/jats:title>\n                    <jats:p>Subjects and HCPs tested subject's finger stick capillary blood in parallel using CONTOUR USB meters; deep finger stick blood was tested on a Yellow Springs Instruments (YSI) glucose analyzer for reference. Duplicate results by both subjects and HCPs were obtained to assess system precision. System accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines [within \u00b115 mg\/dl of mean YSI results (samples &lt;75 mg\/dl) and \u00b120% (samples \u226575 mg\/dl)]. Clinical accuracy was determined by Parkes error grid analysis. Subject labeling comprehension was assessed by HCP ratings of subject proficiency. Key system features and ease-of-use were evaluated by subject questionnaires.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>All subjects who completed the study ( N = 74) successfully performed blood glucose measurements, connected the meter to a laptop computer, and used key features of the system. The system was accurate; 98.6% (146\/148) of subject results and 96.6% (143\/148) of HCP results exceeded ISO 15197:2003 criteria. All subject and HCP results were clinically accurate (97.3%; zone A) or associated with benign errors (2.7%; zone B). The majority of subjects rated features of the BGMS as \u201cvery good\u201d or \u201cexcellent.\u201d<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>CONTOUR USB exceeded ISO 15197:2003 system performance criteria in the hands of untrained lay users. Subjects understood the product labeling, found the system easy to use, and successfully performed blood glucose testing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/193229681100500516","type":"journal-article","created":{"date-parts":[[2014,1,10]],"date-time":"2014-01-10T10:35:52Z","timestamp":1389350152000},"page":"1144-1153","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management"],"prefix":"10.1177","volume":"5","author":[{"given":"Susan M.","family":"List","sequence":"first","affiliation":[{"name":"International Diabetes Center, Park Nicollet Institute, Minneapolis, Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nykole","family":"Starks","sequence":"additional","affiliation":[{"name":"International Diabetes Center, Park Nicollet Institute, Minneapolis, Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Baum","sequence":"additional","affiliation":[{"name":"Bayer HealthCare LLC, Diabetes Care, Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmine","family":"Greene","sequence":"additional","affiliation":[{"name":"Bayer HealthCare LLC, Diabetes Care, Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott","family":"Pardo","sequence":"additional","affiliation":[{"name":"Bayer HealthCare LLC, Diabetes Care, Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joan L.","family":"Parkes","sequence":"additional","affiliation":[{"name":"Bayer HealthCare LLC, Diabetes Care, Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Holly C.","family":"Schachner","sequence":"additional","affiliation":[{"name":"Bayer HealthCare LLC, Diabetes Care, Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Cuddihy","sequence":"additional","affiliation":[{"name":"International Diabetes Center, Park Nicollet Institute, Minneapolis, Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2011,9,1]]},"reference":[{"key":"bibr1-193229681100500516","unstructured":"International Diabetes Federation. Diabetes atlas. Downloads.\n                      http:\/\/www.diabetesatlas.com\/downloads\n                      . Accessed October 7, 2010."},{"key":"bibr2-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa052187"},{"key":"bibr3-193229681100500516","unstructured":"International Diabetes Federation. Diabetes atlas. The economic impacts of diabetes.\n                      http:\/\/www.diabetesatlas.org\/content\/economic-impacts-diabetes\n                      . Accessed October 7, 2010."},{"key":"bibr4-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.321.7258.405"},{"key":"bibr5-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(01)00742-2"},{"key":"bibr6-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1177\/193229680700100121"},{"key":"bibr7-193229681100500516","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-S011"},{"issue":"1","key":"bibr8-193229681100500516","first-page":"RG36","volume":"58","author":"American Diabetes Association","year":"2005","journal-title":"Diabetes Forecast."},{"key":"bibr9-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1177\/193229680700100614"},{"key":"bibr10-193229681100500516","doi-asserted-by":"publisher","DOI":"10.4158\/EP.10.1.67"},{"key":"bibr11-193229681100500516","volume-title":"Development and evaluation of a hexokinase\/glucose-6-phosphate dehydrogenase procedure for use as a national glucose reference method","author":"Neese JW","year":"1976"},{"key":"bibr12-193229681100500516","unstructured":"ISO 15197.\n                      In vitro\n                      diagnostic test systems\u2013requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.\n                      http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_tc\/catalogue_detail.htm?csnumber=54976\n                      . Accessed June 1, 2011."},{"key":"bibr13-193229681100500516","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.8.1143"},{"key":"bibr14-193229681100500516","volume-title":"Point-of-care blood glucose testing in acute and chronic care facilities","author":"National Committee for Clinical Laboratory Standards","year":"2002"},{"key":"bibr15-193229681100500516","volume-title":"Evaluation of precision performance of quantitative measurement methods","author":"National Committee for Clinical Laboratory Standards","year":"2004"},{"key":"bibr16-193229681100500516","volume-title":"Method comparison and bias estimation using patient samples; approved guideline","author":"National Committee for Clinical Laboratory Standards","year":"2002"},{"key":"bibr17-193229681100500516","doi-asserted-by":"publisher","DOI":"10.4158\/EP.7.2.85"},{"key":"bibr18-193229681100500516","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.17.1.81"},{"key":"bibr19-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1177\/193229681000400301"},{"key":"bibr20-193229681100500516","doi-asserted-by":"publisher","DOI":"10.1177\/193229681000400201"}],"container-title":["Journal of Diabetes Science and Technology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/193229681100500516","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/193229681100500516","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T18:14:37Z","timestamp":1777400077000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/193229681100500516"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,9]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2011,9]]}},"alternative-id":["10.1177\/193229681100500516"],"URL":"https:\/\/doi.org\/10.1177\/193229681100500516","relation":{},"ISSN":["1932-2968","1932-2968"],"issn-type":[{"value":"1932-2968","type":"print"},{"value":"1932-2968","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,9]]}}}