{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T15:07:11Z","timestamp":1790089631867,"version":"4.0.1"},"reference-count":47,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2020,3,1]],"date-time":"2020-03-01T00:00:00Z","timestamp":1583020800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004337","name":"roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The increasing offering of patch-based medical devices is accompanied by growing numbers of reported adverse skin reactions. Procedures for testing leachables according to ISO 10993 may not be optimal for lipophilic substances that can be mobilized on skin by sweat and sebum. We propose an improved extraction method for targeted analysis of leachables using low volumes of a sweat-sebum emulsion. The approach is illustrated by the analysis of isobornylacrylate (IBOA), a compound found in some devices and suspected for allergenic potential.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method:<\/jats:title>\n                    <jats:p>Three patch-based products were tested: an implantable device for continuous glucose monitoring (CGM), an intermittently scanned CGM (isCGM) device, and a micro-insulin pump. Quantification of IBOA was performed by gas chromatography and allergenic potential of IBOA levels was assessed by the KeratinoSens cell assay. Different combinations were used for extraction solvent (isopropanol, 5% ethanol-water solution, and sweat-sebum emulsion), extraction volumes (complete immersion vs partial immersion in 2\u2009mm of solvent), and extraction time (3, 5, and 14 days).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Isobornylacrylate was only found in the isCGM device. About 20\u2009mg\/L IBOA were eluted after 3 days in isopropanol but only about 1\u2009mg\/L in ethanol-water. Sweat-sebum emulsion dissolves IBOA better and gives a more stable solution than ethanol-water. Decomposition of IBOA solutions requires adjusted extraction timing or correction of results. In the sweat-sebum extract, IBOA levels were about 20\u2009mg\/L after 3 days and about 30\u2009mg\/L after 5 days, clearly above the threshold found in the KerationSens assay for keratinocyte activation (10\u2009mg\/L).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Extraction by low volumes of sweat-sebum emulsion can be a superior alternative for the targeted simulating-use assessment of leachables in patch-based medical devices.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1932296820908656","type":"journal-article","created":{"date-parts":[[2020,3,2]],"date-time":"2020-03-02T01:31:05Z","timestamp":1583112665000},"page":"792-800","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices, Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products"],"prefix":"10.1177","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1123-7770","authenticated-orcid":false,"given":"Herbert","family":"Fink","sequence":"first","affiliation":[{"name":"Roche Diabetes Care GmbH, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nuno M.","family":"de Barros Fernandes","sequence":"additional","affiliation":[{"name":"Roche Diabetes Care GmbH, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Weissmann","sequence":"additional","affiliation":[{"name":"Roche Diabetes Care GmbH, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manfred","family":"Frey","sequence":"additional","affiliation":[{"name":"Steinbeis Innovationszentrum f\u00fcr Zellkulturtechnik, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,3,1]]},"reference":[{"key":"bibr1-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1002\/adhm.201800275"},{"key":"bibr2-1932296820908656","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2019.0121"},{"key":"bibr3-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2018.0105"},{"issue":"1","key":"bibr4-1932296820908656","first-page":"100","volume":"7","author":"Raina P","year":"2018","journal-title":"Am J PharmTech Res"},{"issue":"10","key":"bibr5-1932296820908656","first-page":"1","author":"de Ridder F","year":"2019","journal-title":"Ther Adv Endoc Metab"},{"key":"bibr6-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-019-0576-8"},{"issue":"1","key":"bibr7-1932296820908656","first-page":"19","volume":"5","author":"Benhamou PY","year":"2019","journal-title":"Lancet Digit Health"},{"key":"bibr8-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0171"},{"key":"bibr9-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.12503"},{"key":"bibr10-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.12873"},{"key":"bibr11-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.12866"},{"key":"bibr12-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1177\/1932296818762946"},{"key":"bibr13-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0007"},{"key":"bibr14-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.13337"},{"key":"bibr15-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.12995"},{"key":"bibr16-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.13075"},{"key":"bibr17-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/cod.13374"},{"key":"bibr18-1932296820908656","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.13023"},{"issue":"5","key":"bibr19-1932296820908656","first-page":"15","volume":"15","author":"Albert DE","year":"2004","journal-title":"Med Device Technol"},{"key":"bibr20-1932296820908656","first-page":"2685","volume-title":"Presentation at: Technical Papers of the Annual Technical Conference-Society of Plastics Engineers Incorporated","volume":"58","author":"Upman PJ"},{"issue":"8","key":"bibr21-1932296820908656","first-page":"8","volume":"1","author":"Bollen LS","year":"2000","journal-title":"Med Device Technol"},{"key":"bibr22-1932296820908656","volume-title":"Conference, Medical Polymers 2006; 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