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           <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>Previous studies showed that inhibiting lymphocyte costimulation reduces declining \u03b2-cell function in individuals newly diagnosed with type 1 diabetes. We tested whether abatacept would delay or prevent progression of type 1 diabetes from normal glucose tolerance (NGT) to abnormal glucose tolerance (AGT) or to diabetes and the effects of treatment on immune and metabolic responses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                    <jats:p>We conducted a phase 2, randomized, placebo-controlled, double-masked trial of abatacept in antibody-positive participants with NGT who received monthly abatacept\/placebo infusions for 12 months. The end point was AGT or diabetes, assessed by oral glucose tolerance tests.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>A total of 101 participants received abatacept and 111 placebo. Of these, 81 (35 abatacept and 46 placebo) met the end point of AGT or type 1 diabetes diagnosis (hazard ratio 0.702; 95% CI 0.452, 1.09; P = 0.11) The C-peptide responses to oral glucose tolerance tests were higher in the abatacept arm (P &amp;lt; 0.03). Abatacept reduced the frequency of inducible T-cell costimulatory (ICOS)+ PD1+ T-follicular helper (Tfh) cells during treatment (P &amp;lt; 0.0001), increased naive CD4+ T cells, and also reduced the frequency of CD4+ regulatory T cells (Tregs) from the baseline (P = 0.0067). Twelve months after treatment, the frequency of ICOS+ Tfh, naive CD4+ T cells, and Tregs returned to baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>Although abatacept treatment for 1 year did not significantly delay progression to glucose intolerance in at-risk individuals, it impacted immune cell subsets and preserved insulin secretion, suggesting that costimulation blockade may modify progression of type 1 diabetes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc22-2200","type":"journal-article","created":{"date-parts":[[2023,3,15]],"date-time":"2023-03-15T09:04:52Z","timestamp":1678871092000},"page":"1005-1013","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":115,"title":["Abatacept for Delay of Type 1 Diabetes Progression in Stage 1 Relatives at Risk: A Randomized, Double-Masked, Controlled Trial"],"prefix":"10.2337","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7609-0434","authenticated-orcid":false,"given":"William E.","family":"Russell","sequence":"first","affiliation":[{"name":"1Departments of Pediatrics and Cell & Developmental Biology, Vanderbilt University Medical Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian N.","family":"Bundy","sequence":"additional","affiliation":[{"name":"2Health Informatics Institute, University of South Florida, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3093-4758","authenticated-orcid":false,"given":"Mark S.","family":"Anderson","sequence":"additional","affiliation":[{"name":"3Department of Medicine, University of California, San Francisco, San Francisco, CA"},{"name":"4Immune Tolerance Network, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura A.","family":"Cooney","sequence":"additional","affiliation":[{"name":"4Immune Tolerance Network, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen E.","family":"Gitelman","sequence":"additional","affiliation":[{"name":"5Diabetes Center, University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin S.","family":"Goland","sequence":"additional","affiliation":[{"name":"6Departments of Medicine and Pediatrics, Columbia University, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter A.","family":"Gottlieb","sequence":"additional","affiliation":[{"name":"7Barbara Davis Diabetes Center, University of Colorado, Anschutz, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4451-9800","authenticated-orcid":false,"given":"Carla J.","family":"Greenbaum","sequence":"additional","affiliation":[{"name":"8Benaroya Research Institute, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2803-1824","authenticated-orcid":false,"given":"Michael J.","family":"Haller","sequence":"additional","affiliation":[{"name":"9Department of Pediatrics, University of Florida, Gainesville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey P.","family":"Krischer","sequence":"additional","affiliation":[{"name":"2Health Informatics Institute, University of South Florida, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0255-4555","authenticated-orcid":false,"given":"Ingrid M.","family":"Libman","sequence":"additional","affiliation":[{"name":"10University of Pittsburgh, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8960-4307","authenticated-orcid":false,"given":"Peter S.","family":"Linsley","sequence":"additional","affiliation":[{"name":"8Benaroya Research Institute, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0281-1240","authenticated-orcid":false,"given":"S. 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