{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T16:07:14Z","timestamp":1791389234975,"version":"4.3.3"},"reference-count":18,"publisher":"American Diabetes Association","issue":"8","license":[{"start":{"date-parts":[[2018,7,20]],"date-time":"2018-07-20T00:00:00Z","timestamp":1532044800000},"content-version":"vor","delay-in-days":37,"URL":"http:\/\/www.diabetesjournals.org\/content\/license"}],"funder":[{"DOI":"10.13039\/100011946","name":"Abbott Diabetes Care","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100011946","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2018,8,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>Cleared blood glucose monitors (BGMs) for personal use may not always deliver levels of accuracy currently specified by international and U.S. regulatory bodies. This study\u2019s objective was to assess the accuracy of 18 such systems cleared by the U.S. Food and Drug Administration representing approximately 90% of commercially available systems used from 2013 to 2015.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                    <jats:p>A total of 1,035 subjects were recruited to have a capillary blood glucose (BG) level measured on six different systems and a reference capillary sample prepared for plasma testing at a reference laboratory. Products were obtained from consumer outlets and tested in three triple-blinded studies. Each of the three participating clinical sites tested a different set of six systems for each of the three studies in a round-robin. In each study, on average, a BGM was tested on 115 subjects. A compliant BG result was defined as within 15% of a reference plasma value (for BG \u2265100 mg\/dL [5.55 mmol\/L]) or within 15 mg\/dL (0.83 mmol\/L) (for BG &amp;lt;100 mg\/dL [5.55 mmol\/L]). The proportion of compliant readings in each study was compared against a predetermined accuracy standard similar to, but more lenient than, current regulatory standards. Other metrics of accuracy included the overall compliance proportion; the proportion of extreme outlier readings differing from the reference value by &amp;gt;20%; modified Bland-Altman analysis including average bias, coefficient of variation, and 95% limits of agreement; and proportion of readings with no clinical risk as determined by the Surveillance Error Grid.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The different accuracy metrics produced almost identical BGM rankings. Six of the 18 systems met the predetermined accuracy standard in all three studies, 5 systems met it in two studies, and 3 met it in one study. Four BGMs did not meet the accuracy standard in any of the three studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance. This information could assist patients, professionals, and payers in choosing products and regulators in evaluating postclearance performance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc17-1960","type":"journal-article","created":{"date-parts":[[2018,6,15]],"date-time":"2018-06-15T10:15:06Z","timestamp":1529057706000},"page":"1681-1688","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":137,"title":["Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors"],"prefix":"10.2337","volume":"41","clinical-trial-number":[{"clinical-trial-number":"nct02789319","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0624-698X","authenticated-orcid":false,"given":"David C.","family":"Klonoff","sequence":"first","affiliation":[{"name":"Mills-Peninsula Medical Center, Diabetes Research Institute, San Mateo, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan Lee","family":"Parkes","sequence":"additional","affiliation":[{"name":"Joan Lee Parkes Consulting, Inc., Bristol, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris P.","family":"Kovatchev","sequence":"additional","affiliation":[{"name":"Center for Diabetes Technology, University of Virginia, Charlottesville, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Kerr","sequence":"additional","affiliation":[{"name":"William Sansum Diabetes Center, Santa Barbara, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy C.","family":"Bevier","sequence":"additional","affiliation":[{"name":"William Sansum Diabetes Center, Santa Barbara, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald L.","family":"Brazg","sequence":"additional","affiliation":[{"name":"Rainier Clinical Research Center, Inc., Renton, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Christiansen","sequence":"additional","affiliation":[{"name":"Diablo Clinical Research, Walnut Creek, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy S.","family":"Bailey","sequence":"additional","affiliation":[{"name":"AMCR Institute, Inc., Escondido, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James H.","family":"Nichols","sequence":"additional","affiliation":[{"name":"School of Medicine, Vanderbilt University, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Kohn","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2018,6,13]]},"reference":[{"key":"2022031300584504700_B1","doi-asserted-by":"crossref","first-page":"1575","DOI":"10.1177\/193229681300700618","article-title":"Blood glucose pattern management in diabetes: creating order from disorder","volume":"7","author":"Choudhary","year":"2013","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B2","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1177\/193229681000400309","article-title":"Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study","volume":"4","author":"Breton","year":"2010","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B3","author":"International Organization for Standardization","year":"2013"},{"key":"2022031300584504700_B4","unstructured":"U.S. Department of Health and Human Services, U.S. Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff [Internet], 2016. Available from https:\/\/www.fda.gov\/downloads\/ucm380327.pdf. Accessed 24 May 2018"},{"key":"2022031300584504700_B5","doi-asserted-by":"crossref","first-page":"895","DOI":"10.1177\/1932296815584797","article-title":"Performance of cleared blood glucose monitors","volume":"9","author":"Klonoff","year":"2015","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B6","doi-asserted-by":"crossref","first-page":"1240","DOI":"10.1177\/1932296817713220","article-title":"Do the new FDA guidance documents help improving performance of blood glucose monitoring systems compared with ISO 15197","volume":"11","author":"Freckmann","year":"2017","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B7","doi-asserted-by":"crossref","first-page":"558","DOI":"10.1177\/1932296816672237","article-title":"Comparative accuracy of 17 point-of-care glucose meters","volume":"11","author":"Ekhlaspour","year":"2017","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B8","doi-asserted-by":"crossref","first-page":"697","DOI":"10.1177\/1932296815614587","article-title":"Development of the Diabetes Technology Society blood glucose monitor system surveillance protocol","volume":"10","author":"Klonoff","year":"2016","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B9","author":"IMS Health Information Service"},{"key":"2022031300584504700_B10","author":"Murrin","year":"2014"},{"key":"2022031300584504700_B11","volume-title":"2014-15 Economic Report on Retail, Mail, and Specialty Pharmacies","author":"Fein","year":"2015"},{"key":"2022031300584504700_B12","doi-asserted-by":"crossref","first-page":"658","DOI":"10.1177\/1932296814539589","article-title":"The surveillance error grid","volume":"8","author":"Klonoff","year":"2014","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B13","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1177\/1932296814539590","article-title":"Computing the surveillance error grid analysis: procedure and examples","volume":"8","author":"Kovatchev","year":"2014","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B14","doi-asserted-by":"crossref","first-page":"971","DOI":"10.1177\/193229680900300446","article-title":"Glucose meters: a review of technical challenges to obtaining accurate results","volume":"3","author":"Tonyushkina","year":"2009","journal-title":"J Diabetes Sci Technol"},{"key":"2022031300584504700_B15","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1089\/dia.2013.0047","article-title":"System accuracy of blood glucose monitoring systems: impact of use by patients and ambient conditions","volume":"15","author":"Schmid","year":"2013","journal-title":"Diabetes Technol Ther"},{"key":"2022031300584504700_B16","unstructured":"Diabetes Technology Society. Diabetes Technology Society outlines potential post-clearance surveillance program to address inaccuracy of blood glucose monitors [article online], 2013. Available from https:\/\/www.prnewswire.com\/news-releases\/diabetes-technology-society-outlines-potential-post-clearance-surveillance-program-to-address-inaccuracy-of-blood-glucose-monitors-223628961.html. Accessed 18 December 2017"},{"key":"2022031300584504700_B17","unstructured":"U.S. Department of Health and Human Services, Office of Inspector General. Medicare market shares of mail order diabetes test strips from April to June 2016 [article online], 2016. Available from https:\/\/oig.hhs.gov\/oei\/reports\/oei-04-16-00470.pdf. Accessed 18 December 2017"},{"key":"2022031300584504700_B18","doi-asserted-by":"crossref","first-page":"847","DOI":"10.1089\/dia.2010.0076","article-title":"Quality of glucose measurement with blood glucose meters at the point-of-care: relevance of interfering factors","volume":"12","author":"Heinemann","year":"2010","journal-title":"Diabetes Technol Ther"}],"container-title":["Diabetes Care"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/care.diabetesjournals.org\/syndication\/doi\/10.2337\/dc17-1960","content-type":"unspecified","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/41\/8\/1681\/527488\/dc171960.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/41\/8\/1681\/527488\/dc171960.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,12]],"date-time":"2022-03-12T23:32:11Z","timestamp":1647127931000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/care\/article\/41\/8\/1681\/36377\/Investigation-of-the-Accuracy-of-18-Marketed-Blood"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6,13]]},"references-count":18,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2018,6,13]]},"published-print":{"date-parts":[[2018,8,1]]}},"URL":"https:\/\/doi.org\/10.2337\/dc17-1960","relation":{},"ISSN":["0149-5992","1935-5548"],"issn-type":[{"value":"0149-5992","type":"print"},{"value":"1935-5548","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6,13]]}}}