{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T12:51:52Z","timestamp":1777899112292,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T00:00:00Z","timestamp":1630368000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"LifeScan Scotland Ltd."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>On-going manufacturer-led post-market surveillance (PMS), assessing the clinical accuracy of blood glucose monitoring (BGM) systems, is critical to substantiate the performance of such products for people with diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods:<\/jats:title>\n                    <jats:p>Batches of Verio test-strip product were randomly and routinely selected over the period from launch of an improved-algorithm product to reporting date and sent to 3 clinic sites for clinician-led accuracy assessment. Accuracy is reported as per recently adopted FDA guidance for BGM systems, EN ISO 15197:2015 and MARD\/MAD (Mean absolute relative difference\/Mean absolute difference).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Thirty-three individual test-strip batches were evaluated corresponding to 506 unique donors. Accuracy performance - FDA: 98.9% of values within \u00b115% of comparator; ISO: 99.0% within \u00b115\u2009mg\/dL or \u00b115% at &lt;100\u2009mg\/dL (&lt;5.55\u2009mmol\/L) or \u2265100\u2009mg\/dL (\u22655.55\u2009mmol\/L) glucose, respectively. Overall MARD was 4.19% with a MARD range of 3.54%-5.73% across all test strip batches.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This post-market surveillance program demonstrates the new BGM system consistently meets measures of clinical accuracy specified by regulators. This program supports a growing demand by regulators for real-world evidence demonstrating consistent in-market product efficacy as opposed to the current largely passive approach that relies on assessment of reports filed by device users.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/19322968211039465","type":"journal-article","created":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T05:03:18Z","timestamp":1630386198000},"page":"133-140","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance"],"prefix":"10.1177","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1983-0461","authenticated-orcid":false,"given":"Steven","family":"Setford","sequence":"first","affiliation":[{"name":"LifeScan Scotland Ltd., Inverness, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zuifang","family":"Liu","sequence":"additional","affiliation":[{"name":"LifeScan Scotland Ltd., Inverness, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"McColl","sequence":"additional","affiliation":[{"name":"LifeScan Scotland Ltd., Inverness, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2399-9016","authenticated-orcid":false,"given":"Stuart","family":"Phillips","sequence":"additional","affiliation":[{"name":"LifeScan Scotland Ltd., Inverness, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hilary","family":"Cameron","sequence":"additional","affiliation":[{"name":"LifeScan Scotland Ltd., Inverness, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8006-1844","authenticated-orcid":false,"given":"Mike","family":"Grady","sequence":"additional","affiliation":[{"name":"LifeScan Scotland Ltd., Inverness, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2021,8,31]]},"reference":[{"key":"bibr1-19322968211039465","volume-title":"Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. 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