{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T11:23:14Z","timestamp":1790680994912,"version":"4.1.0"},"reference-count":38,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/100004440","name":"Wellcome Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004440","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001067","name":"Juvenile Diabetes Research Foundation Australia","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001067","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007028","name":"Leona M. and Harry B. 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Infants are randomised 1:1 to daily oral insulin (7.5\u2009mg for 2 months, 22.5\u2009mg for 2 months, 67.5\u2009mg until age 36.0 months) or placebo, and followed for a maximum of 7 years. Treatment and follow-up is stopped if a child develops diabetes. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies or diabetes. Other outcomes are: (1) Any persistent confirmed beta-cell autoantibody (glutamic acid decarboxylase (GADA), IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4) Abnormal glucose tolerance or diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study is approved by the ethical committees of all participating clinical sites. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03364868\" ext-link-type=\"clintrialgov\">NCT03364868<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-028578","type":"journal-article","created":{"date-parts":[[2019,6,29]],"date-time":"2019-06-29T06:45:22Z","timestamp":1561790722000},"page":"e028578","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":85,"title":["Oral insulin therapy for primary prevention of type 1 diabetes in infants with high genetic risk: the GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) study protocol"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03364868","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Anette-Gabriele","family":"Ziegler","sequence":"first","affiliation":[{"name":"Institute of Diabetes Research, Helmholtz Zentrum M\u00fcnchen, Neuherberg, Germany"},{"name":"Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Medical faculty, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Achenbach","sequence":"additional","affiliation":[{"name":"Institute of Diabetes Research, Helmholtz Zentrum M\u00fcnchen, Neuherberg, Germany"},{"name":"Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Medical faculty, Munich, 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