{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T18:53:16Z","timestamp":1781722396862,"version":"3.54.5"},"reference-count":28,"publisher":"American Diabetes Association","issue":"8","license":[{"start":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T00:00:00Z","timestamp":1748304000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/journals\/pages\/license"}],"funder":[{"DOI":"10.13039\/100007028","name":"Leona M. and Harry B. Helmsley Charitable Trust","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100007028","id-type":"DOI","asserted-by":"publisher"}]},{"name":"MRFF Accelerated Research Funding Program"},{"DOI":"10.13039\/501100001067","name":"JDRF Australia","doi-asserted-by":"crossref","award":["2-SRA-2022-1282-M-X"],"award-info":[{"award-number":["2-SRA-2022-1282-M-X"]}],"id":[{"id":"10.13039\/501100001067","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001067","name":"JDRF Australia","doi-asserted-by":"crossref","award":["4-SRA-2020-912-M-B"],"award-info":[{"award-number":["4-SRA-2020-912-M-B"]}],"id":[{"id":"10.13039\/501100001067","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001067","name":"JDRF Australia","doi-asserted-by":"crossref","award":["4-SRA-2022-1246-M-N"],"award-info":[{"award-number":["4-SRA-2022-1246-M-N"]}],"id":[{"id":"10.13039\/501100001067","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100017618","name":"Division of Diabetes, Endocrinology, and Metabolic Diseases","doi-asserted-by":"publisher","award":["U01DK061010, U01 DK061016, U01 DK061034, U01 DK061"],"award-info":[{"award-number":["U01DK061010, U01 DK061016, U01 DK061034, U01 DK061"]}],"id":[{"id":"10.13039\/100017618","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000097","name":"National Center for Research Resources","doi-asserted-by":"publisher","award":["UL1 RR024131, UL1 RR024139, UL1 RR024153, UL1 RR02"],"award-info":[{"award-number":["UL1 RR024131, UL1 RR024139, UL1 RR024153, UL1 RR02"]}],"id":[{"id":"10.13039\/100000097","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100025520","name":"Medical Research Future Fund","doi-asserted-by":"crossref","award":["RARUR000103"],"award-info":[{"award-number":["RARUR000103"]}],"id":[{"id":"10.13039\/501100025520","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>Baricitinib preserves \u03b2-cell function in people with recently diagnosed type 1 diabetes. We aimed to determine whether simple routine clinical measures could be used to assess \u03b2-cell preservation and predict treatment response.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGNS AND METHOD<\/jats:title>\n                    <jats:p>Measures of \u03b2-cell function derived from clinical and biochemical measures were calculated using data from the BAricitinib in Newly DIagnosed Type 1 diabetes (BANDIT) randomized trial of baricitinib in recent-onset type 1 diabetes. Measures that reported and predicted treatment efficacy were determined using linear regression and receiver operator characteristic analysis, respectively. Therapeutic predictors were validated using data from trials of rituximab, abatacept, and antithymocyte globulin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Quantitative response score (QRS), fasting C-peptide, and model-estimated C-peptide (CPest) most reliably differentiated placebo-treated from baricitinib-treated participants at 24 and 48 weeks. The Beta2 score, derived from fasting glucose, C-peptide, HbA1c, and insulin dose at 12 weeks, was optimal for predicting QRS &amp;gt;0 following 1 year of treatment with baricitinib and the other immunotherapies (areas under receiver operator curve 0.864 and 0.765, respectively). A 6.2% decrease in the Beta2 score at week 12 predicted significant improvement in HbA1c (\u22120.6% or \u22126 mmol\/mol) and insulin use (\u22120.26 units\/kg\/day) in combined data from the rituximab, abatacept, and antithymocyte globulin trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>QRS, fasting C-peptide, and CPest could be used as more efficient, less burdensome primary outcome measures for future immunotherapy trials. The ability of the Beta2 score to predict treatment responses could facilitate adaptive trial designs and help guide treatment decisions in the clinic.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc25-0565","type":"journal-article","created":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T11:53:36Z","timestamp":1748346816000},"page":"1370-1376","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":2,"title":["\u03b2-Cell Function Derived From Routine Clinical Measures Reports and Predicts Treatment Response to Immunotherapy in Recent-Onset Type 1 Diabetes"],"prefix":"10.2337","volume":"48","author":[{"given":"Michelle","family":"So","sequence":"first","affiliation":[{"name":"Department of Diabetes and Endocrinology, Royal Melbourne Hospital 1 , Parkville, Victoria, Australia"},{"name":"St Vincent\u2019s Institute of Medical Research 2 , Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Vogrin","sequence":"additional","affiliation":[{"name":"Department of Medicine, St Vincent\u2019s Hospital, University of Melbourne 3 , Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Waibel","sequence":"additional","affiliation":[{"name":"St Vincent\u2019s Institute of Medical Research 2 , Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas W.H.","family":"Kay","sequence":"additional","affiliation":[{"name":"St Vincent\u2019s Institute of Medical Research 2 , Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5197-3529","authenticated-orcid":false,"given":"John M.","family":"Wentworth","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Endocrinology, Royal Melbourne Hospital 1 , Parkville, Victoria, Australia"},{"name":"St Vincent\u2019s Institute of Medical Research 2 , Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2025,5,27]]},"reference":[{"key":"2026061714331333400_B1","doi-asserted-by":"crossref","first-page":"990","DOI":"10.1001\/jama.2023.2064","article-title":"Effect of verapamil on pancreatic beta cell function in newly diagnosed pediatric type 1 diabetes: a randomized clinical trial","volume":"329","author":"Forlenza","year":"2023","journal-title":"JAMA"},{"key":"2026061714331333400_B2","doi-asserted-by":"crossref","first-page":"1917","DOI":"10.2337\/dc18-0494","article-title":"Low-dose anti-thymocyte globulin (ATG) preserves \u03b2-cell function and improves HbA1c in new-onset type 1 diabetes","volume":"41","author":"Haller","year":"2018","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B3","doi-asserted-by":"crossref","first-page":"2007","DOI":"10.1056\/NEJMoa2006136","article-title":"Golimumab and beta-cell function in youth with new-onset type 1 diabetes","volume":"383","author":"Quattrin","year":"2020","journal-title":"N Engl J Med"},{"key":"2026061714331333400_B4","doi-asserted-by":"crossref","first-page":"2140","DOI":"10.1056\/NEJMoa2306691","article-title":"Baricitinib and \u03b2-cell function in patients with new-onset type 1 diabetes","volume":"389","author":"Waibel","year":"2023","journal-title":"N Engl J Med"},{"key":"2026061714331333400_B5","doi-asserted-by":"crossref","first-page":"1867","DOI":"10.1007\/s12325-023-02445-w","article-title":"Baricitinib safety for events of special interest in populations at risk: analysis from randomised trial data across rheumatologic and dermatologic indications","volume":"40","author":"Taylor","year":"2023","journal-title":"Adv Ther"},{"key":"2026061714331333400_B6","doi-asserted-by":"crossref","first-page":"2143","DOI":"10.1056\/NEJMoa0904452","article-title":"Rituximab, B-lymphocyte depletion, and preservation of beta-cell function","volume":"361","author":"Pescovitz","year":"2009","journal-title":"N Engl J Med"},{"key":"2026061714331333400_B7","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1016\/S0140-6736(11)60886-6","article-title":"Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial","volume":"378","author":"Orban","year":"2011","journal-title":"Lancet"},{"key":"2026061714331333400_B8","doi-asserted-by":"crossref","first-page":"285","DOI":"10.2337\/dc23-1750","article-title":"Low-dose antithymocyte globulin: a pragmatic approach to treating stage 2 type 1 diabetes","volume":"47","author":"Foster","year":"2024","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B9","doi-asserted-by":"crossref","first-page":"1966","DOI":"10.2337\/dc07-2451","article-title":"Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes","volume":"31","author":"Greenbaum","year":"2008","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B10","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1007\/s00125-018-4722-z","article-title":"Beta cell function in type 1 diabetes determined from clinical and fasting biochemical variables","volume":"62","author":"Wentworth","year":"2019","journal-title":"Diabetologia"},{"key":"2026061714331333400_B11","doi-asserted-by":"crossref","first-page":"1384","DOI":"10.2337\/dc08-1987","article-title":"New definition for the partial remission period in children and adolescents with type 1 diabetes","volume":"32","author":"Mortensen","year":"2009","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B12","doi-asserted-by":"crossref","first-page":"2704","DOI":"10.1111\/ajt.13807","article-title":"Validation of the BETA-2 score: an improved tool to estimate beta cell function after clinical islet transplantation using a single fasting blood sample","volume":"16","author":"Forbes","year":"2016","journal-title":"Am J Transplant"},{"key":"2026061714331333400_B13","doi-asserted-by":"crossref","first-page":"166","DOI":"10.1111\/pedi.12808","article-title":"An improved clinical model to predict stimulated C-peptide in children with recent-onset type 1 diabetes","volume":"20","author":"Buchanan","year":"2019","journal-title":"Pediatr Diabetes"},{"key":"2026061714331333400_B14","doi-asserted-by":"crossref","first-page":"885","DOI":"10.1007\/s00125-020-05088-6","article-title":"Clinical trial data validate the C-peptide estimate model in type 1 diabetes","volume":"63","author":"Wentworth","year":"2020","journal-title":"Diabetologia"},{"key":"2026061714331333400_B15","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1007\/s00592-020-01604-7","article-title":"Validation in the general population of a C-peptide estimate equation to measure beta cell function in recent-onset type 1 diabetes","volume":"58","author":"Wang","year":"2021","journal-title":"Acta Diabetol"},{"key":"2026061714331333400_B16","doi-asserted-by":"crossref","first-page":"e00143","DOI":"10.1002\/edm2.143","article-title":"A quantitative measure of treatment response in recent-onset type 1 diabetes","volume":"3","author":"Bundy","year":"2020","journal-title":"Endocrinol Diabetes Metab"},{"key":"2026061714331333400_B17","doi-asserted-by":"crossref","first-page":"2191","DOI":"10.2337\/diacare.21.12.2191","article-title":"Correct homeostasis model assessment (HOMA) evaluation uses the computer program","volume":"21","author":"Levy","year":"1998","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B18","doi-asserted-by":"crossref","DOI":"10.1002\/9780470316696","volume-title":"Multiple Imputation for Nonresponse in Surveys.","author":"Rubin","year":"1987"},{"key":"2026061714331333400_B19","doi-asserted-by":"crossref","first-page":"1048","DOI":"10.2337\/dc24-0171","article-title":"Early metabolic endpoints identify persistent treatment efficacy in recent-onset type 1 diabetes immunotherapy trials","volume":"47","author":"Jacobsen","year":"2024","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B20","doi-asserted-by":"crossref","first-page":"915","DOI":"10.1016\/S2213-8587(23)00267-X","article-title":"C-peptide and metabolic outcomes in trials of disease modifying therapy in new-onset type 1 diabetes: an individual participant meta-analysis","volume":"11","author":"Taylor","year":"2023","journal-title":"Lancet Diabetes Endocrinol"},{"key":"2026061714331333400_B21","doi-asserted-by":"crossref","first-page":"1487","DOI":"10.2337\/diacare.27.6.1487","article-title":"Use and abuse of HOMA modeling","volume":"27","author":"Wallace","year":"2004","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B22","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1007\/s00125-021-05573-6","article-title":"HOMA2-B enhances assessment of type 1 diabetes risk among TrialNet Pathway to Prevention participants","volume":"65","author":"Felton","year":"2022","journal-title":"Diabetologia"},{"key":"2026061714331333400_B23","doi-asserted-by":"crossref","first-page":"1424","DOI":"10.1038\/s41591-024-02908-9","article-title":"Continuous glucose monitoring and intrapersonal variability in fasting glucose","volume":"30","author":"Shilo","year":"2024","journal-title":"Nat Med"},{"key":"2026061714331333400_B24","doi-asserted-by":"crossref","first-page":"1436","DOI":"10.1177\/19322968211023522","article-title":"Accuracy of CGM systems during continuous and interval exercise in adults with type 1 diabetes","volume":"16","author":"Da Prato","year":"2022","journal-title":"J Diabetes Sci Technol"},{"key":"2026061714331333400_B25","doi-asserted-by":"crossref","first-page":"1825","DOI":"10.2337\/dc23-0089","article-title":"Real-world accuracy of CGM in inpatient critical and noncritical care settings at a safety-net hospital","volume":"46","author":"Finn","year":"2023","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B26","doi-asserted-by":"crossref","first-page":"S146","DOI":"10.2337\/dc25-S007","article-title":"7. Diabetes technology: Standards of Care in Diabetes\u20142025","volume":"48","author":"American Diabetes Association Professional Practice Committee","year":"2025","journal-title":"Diabetes Care"},{"key":"2026061714331333400_B27","doi-asserted-by":"crossref","first-page":"e14528","DOI":"10.1111\/dme.14528","article-title":"Continuous glucose monitoring: a review of the evidence in type 1 and 2 diabetes mellitus","volume":"38","author":"Lin","year":"2021","journal-title":"Diabet Med"},{"key":"2026061714331333400_B28","doi-asserted-by":"crossref","first-page":"1167","DOI":"10.1007\/s00125-015-3559-y","article-title":"CGM-measured glucose values have a strong correlation with C-peptide, HbA1c and IDAAC, but do poorly in predicting C-peptide levels in the two years following onset of diabetes","volume":"58","author":"Buckingham","year":"2015","journal-title":"Diabetologia"}],"container-title":["Diabetes Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/48\/8\/1370\/811060\/dc250565.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/48\/8\/1370\/811060\/dc250565.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T18:33:25Z","timestamp":1781721205000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/care\/article\/48\/8\/1370\/160538\/Cell-Function-Derived-From-Routine-Clinical"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,27]]},"references-count":28,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,5,27]]},"published-print":{"date-parts":[[2025,8,1]]}},"URL":"https:\/\/doi.org\/10.2337\/dc25-0565","relation":{},"ISSN":["0149-5992","1935-5548"],"issn-type":[{"value":"0149-5992","type":"print"},{"value":"1935-5548","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,27]]}}}