{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T19:52:35Z","timestamp":1792785155797,"version":"4.5.0"},"reference-count":10,"publisher":"Georg Thieme Verlag KG","issue":"10","license":[{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Leona M. and Harry B. Helmsley\nCharitable Trust","award":["#2003-04286 GPPAD coordinating center continuation, #2007-04031\nGPPAD-04 study: Supplementation with B,#2018PG-T1D022 GPPAD-02 study and\nGPPAD coordinati, #2110-04841 Continuation of the GPPAD-02-Study:\nIde"],"award-info":[{"award-number":["#2003-04286 GPPAD coordinating center continuation, #2007-04031\nGPPAD-04 study: Supplementation with B,#2018PG-T1D022 GPPAD-02 study and\nGPPAD coordinati, #2110-04841 Continuation of the GPPAD-02-Study:\nIde"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Metab Res"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Screening using polygenic risk scores can identify infants at increased risk for\nislet autoimmunity and type 1 diabetes. The Supplementation with\nB\n               ifidobacterium\n                infantis (EVC001) for Mitigation of\nType 1 Diabetes Autoimmunity study is a primary prevention study that enrolled\ninfants aged between 7 and 42 days with an elevated genetic risk for type 1\ndiabetes identified through newborn screening. Here, we describe the screening\nprocess that enabled timely genetic risk assessment and enrolment into the\nSupplementation with B.\n                infantis (EVC001) for Mitigation of Type 1\nDiabetes Autoimmunity clinical intervention study within the required enrolment\nwindow. Screening was conducted in Belgium, Germany, Poland, Sweden, and the\nUnited Kingdom. Among 257,784 screened newborns included in the analysis, 3,309\nnewborns (1.3%) had an eligible genotype associated with a&gt;10% risk of\ndeveloping early-stage type 1 diabetes by 6 years of age. Samples were collected\nat a median age of 2 days (interquartile range, 0\u20133), registered at a median age\nof 9 days (interquartile range, 6\u201311), and genotyped at a median age of 21 days\n(interquartile range, 18\u201324). Study sites received validated genotyping results\nat a median age of 22 days (interquartile range, 19\u201325). Consultation visits\noccurred at a median age of 29 days (interquartile range, 25\u201334) and enrolment\ninto the Supplementation with B. infantis (EVC001) for Mitigation of Type\n1 Diabetes Autoimmunity study took place at a median age of 38 days\n(interquartile range, 35\u201341). Overall, 1,149 eligible infants were enrolled into\nthe Supplementation with B. infantis (EVC001) for Mitigation of Type 1\nDiabetes Autoimmunity study (34.7% of eligible infants). These findings\ndemonstrate the feasibility of accelerated genetic screening programs and show\nthat newborn screening workflows can be completed within the first 6 weeks of\nlife to support timely enrolment into early intervention trials.<\/jats:p>","DOI":"10.1055\/a-2960-5380","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:42:05Z","timestamp":1790635325000},"page":"391-398","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility of Fast Turnaround Genetic Screening for Type 1 Diabetes\n    Risk in Newborns \u2013 Recruiting Infants for the Global Platform for the Prevention\nof Autoimmune Diabetes Primary Prevention Study Supplementation with\nB\n               ifidobacterium\n                infantis for Mitigation of Type 1\nDiabetes Autoimmunity"],"prefix":"10.1055","volume":"58","clinical-trial-number":[{"clinical-trial-number":"nct03316261","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Annika","family":"Fehn","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ezio","family":"Bonifacio","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]},{"name":"Technische Universit\u00e4t Dresden, SN, Germany","place":["Dresden"],"department":["Center for Regenerative Therapies"]},{"name":"Technische Universit\u00e4t Dresden, Germany","place":["Dresden"],"department":["Paul Langerhans Institut"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Bonnin","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Casteels","sequence":"additional","affiliation":[{"name":"KU Leuven University Hospitals Leuven Gasthuisberg\nCampus, Flanders, Belgium","place":["Leuven"],"department":["Department of Pediatrics"]},{"name":"KU Leuven, Flanders, Belgium","place":["Leuven"],"department":["Department of Development and Regeneration"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"G\u00fcndert","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Heigermoser","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ida","family":"J\u00f6nsson","sequence":"additional","affiliation":[{"name":"Lund University, Sk\u00e5ne County, Sweden","place":["Lund"],"department":["Unit for Pediatric Endocrinology, Department of Clinical Sciences\nMalm\u00f6"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Kordonouri","sequence":"additional","affiliation":[{"name":"Auf der Bult Children's Hospital, NDS, Germany","place":["Hanover"],"department":["Hannoversche Kinderheilanstalt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Loff","sequence":"additional","affiliation":[{"name":"Technische Universit\u00e4t Dresden, SN, Germany","place":["Dresden"],"department":["Center for Regenerative Therapies"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Lundgren","sequence":"additional","affiliation":[{"name":"Lund University, Sk\u00e5ne County, Sweden","place":["Lund"],"department":["Unit for Pediatric Endocrinology, Department of Clinical Sciences\nMalm\u00f6"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariusz","family":"O\u0142tarzewski","sequence":"additional","affiliation":[{"name":"Instytut Matki i Dziecka, Masovian Voivodeship, Poland","place":["Warsaw"],"department":["Department of Screening and Metabolic Diagnostics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Owen","sequence":"additional","affiliation":[{"name":"Great North Children's Hospital, England, United Kingdom of Great Britain and Northern Ireland","place":["Newcastle upon Tyne"],"department":["General Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Robson","sequence":"additional","affiliation":[{"name":"Great North Children's Hospital, England, United Kingdom of Great Britain and Northern Ireland","place":["Newcastle upon Tyne"],"department":["General Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Roloff","sequence":"additional","affiliation":[{"name":"Auf der Bult Children's Hospital, NDS, Germany","place":["Hanover"],"department":["Hannoversche Kinderheilanstalt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnieszka","family":"Szypowska","sequence":"additional","affiliation":[{"name":"University Clinical Center of the Medical University of\nWarsaw, Masovian Voivodeship, Poland","place":["Warsaw"],"department":["Department of Paediatric Diabetology and Paediatrics"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Rochtus","sequence":"additional","affiliation":[{"name":"KU Leuven University Hospitals Leuven Gasthuisberg\nCampus, Flanders, Belgium","place":["Leuven"],"department":["Department of Pediatrics"]},{"name":"KU Leuven, Flanders, Belgium","place":["Leuven"],"department":["Department of Development and Regeneration"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Weiss","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christiane","family":"Winkler","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anette-Gabriele","family":"Ziegler","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]},{"name":"Technische Universit\u00e4t M\u00fcnchen Fakult\u00e4t f\u00fcr\nMedizin, Germany","place":["Munich"],"department":["Forschergruppe Diabetes"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Haupt","sequence":"additional","affiliation":[{"name":"Helmholtz Center Munich German Research Center for\nEnvironmental Health, Germany","place":["Neuherberg"],"department":["Institute of Diabetes Research"]},{"name":"Technische Universit\u00e4t M\u00fcnchen Fakult\u00e4t f\u00fcr\nMedizin, Germany","place":["Munich"],"department":["Forschergruppe Diabetes"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2026,9,28]]},"reference":[{"issue":"04","key":"ref1","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1016\/j.molmet.2016.02.003","article-title":"Primary prevention of beta-cell autoimmunity and type 1 diabetes \u2013 the global\nplatform for the prevention of autoimmune diabetes (GPPAD) perspectives","volume":"5","author":"A G Ziegler","year":"2016","journal-title":"Mol Metab"},{"issue":"04","key":"ref2","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002548","article-title":"Genetic scores to stratify risk of developing multiple islet autoantibodies and\ntype 1 diabetes: a prospective study in children","volume":"15","author":"E Bonifacio","year":"2018","journal-title":"PLoS Med"},{"issue":"06","key":"ref3","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1111\/pedi.12870","article-title":"Identification of infants with increased type 1 diabetes genetic risk for\nenrollment into primary prevention trials-GPPAD-02 study design and first\nresults","volume":"20","author":"C Winkler","year":"2019","journal-title":"Pediatr Diabetes"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"2564","DOI":"10.1016\/S0140-6736(25)01726-X","article-title":"Efficacy of once-daily, high-dose, oral insulin immunotherapy in children\ngenetically at risk for type 1 diabetes (POInT): a European, randomised,\nplacebo-controlled, primary prevention trial","volume":"406","author":"A G Ziegler","year":"2025","journal-title":"Lancet"},{"issue":"06","key":"ref5","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2018-028578","article-title":"Oral insulin therapy for primary prevention of type 1 diabetes in infants with\nhigh genetic risk: the GPPAD-POInT (Global platform for the prevention of\nautoimmune diabetes primary oral insulin trial) study protocol","volume":"9","author":"A G Ziegler","year":"2019","journal-title":"BMJ Open"},{"issue":"11","key":"ref6","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-052449","article-title":"Supplementation with Bifidobacterium longum subspecies infantis\nEVC001 for mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A\nrandomised controlled trial protocol","volume":"11","author":"A G Ziegler","year":"2021","journal-title":"BMJ Open"},{"issue":"08","key":"ref8","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1055\/a-2884-2277","article-title":"Determinants of infant participation and non-participation in primary prevention\ntrials","volume":"58","author":"F W\u00f6rl","year":"2026","journal-title":"Horm Metab Res"},{"key":"ref9","first-page":"135","volume-title":"Multicenter and network trials","author":"S Baksh","year":"2022"},{"issue":"05","key":"ref10","doi-asserted-by":"crossref","first-page":"792","DOI":"10.2337\/dc25-2248","article-title":"Everyone or just some? Cost-effectiveness of general population versus targeted\nscreening strategies for type 1 diabetes in Canada","volume":"49","author":"S Mital","year":"2026","journal-title":"Diabetes Care"},{"issue":"08","key":"ref11","doi-asserted-by":"crossref","first-page":"1247","DOI":"10.1038\/s41591-020-0930-4","article-title":"A combined risk score enhances prediction of type 1 diabetes among susceptible\nchildren","volume":"26","author":"L A Ferrat","year":"2020","journal-title":"Nat Med"}],"container-title":["Hormone and Metabolic Research"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2960-5380.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T22:37:09Z","timestamp":1792622229000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2960-5380"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,28]]},"references-count":10,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2026,10,21]]},"published-print":{"date-parts":[[2026,10]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2960-5380","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0018-5043","1439-4286"],"issn-type":[{"value":"0018-5043","type":"print"},{"value":"1439-4286","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,28]]}}}