{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T14:12:35Z","timestamp":1788444755162,"version":"build-2803163510"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diabetologia"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims\/hypothesis<\/jats:title>\n                    <jats:p>Clinical trials of interventions to preserve beta cell function in new-onset type 1 diabetes frequently employ participant-reported outcome measures (PROMs). However, the expected changes in PROMs scores immediately following diagnosis and their association with residual beta cell function, metabolic markers and continuous glucose monitoring (CGM) are unclear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Repeated PROMs including Paediatric Quality of Life Inventory diabetes module (PedsQL) and hypoglycaemia fear survey (HFS) were recorded from participants aged 10\u201318 years with newly diagnosed type 1 diabetes and their parents in two clinical trials: CLOuD (\n                      <jats:italic>N<\/jats:italic>\n                      =97, hybrid closed loop [HCL] vs multiple daily injections [MDI]) and USTEKID (\n                      <jats:italic>N<\/jats:italic>\n                      =72, ustekinumab immunotherapy vs placebo). Scores were compared with serial mixed meal-stimulated C-peptide levels (AUC C-peptide), HbA\n                      <jats:sub>1c<\/jats:sub>\n                      and CGM data.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      PedsQL and HFS scores for children\/adolescents and their parents showed wide variation between individuals but did not change substantially within individuals over the first 48 months from diagnosis. Baseline scores were highly predictive of scores at 12\u201348 months (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001). PedsQL scores were higher (better) in those reported by children\/adolescents than by their parents (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.01). In contrast, HFS scores were higher in parents than children (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001), indicating more fear. Strong correlations were observed between child and parent scores (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001). No significant improvement in these scores was detected following intervention (ustekinumab or HCL). Meta-analysis revealed modest but statistically significant associations between HbA\n                      <jats:sub>1c<\/jats:sub>\n                      and PedsQL (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =\u22120.11; 95% CI \u22120.20, \u22120.03) and HFS (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =0.11; 95% CI 0.00, 0.21), and between CGM time in range and PedsQL (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =0.14; 95% CI 0.03, 0.26) but not HFS (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =\u22120.05; 95% CI \u22120.16, 0.06). Beta cell function (AUC C-peptide) was strongly associated with HbA\n                      <jats:sub>1c<\/jats:sub>\n                      (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =\u22120.29; 95% CI \u22120.39, \u22120.20) and CGM time in range (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =0.41; 95% CI 0.30, 0.52). Higher beta cell function showed a trend towards better PedsQL (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =0.11; 95% CI \u22120.03, 0.25) and lower HFS (\u03b2\n                      <jats:sub>(std)<\/jats:sub>\n                      =\u22120.05; 95% CI \u22120.17, 0.07) but this did not reach statistical significance.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>\n                      PedsQL and HFS scores changed little during the first 48 months after diagnosis of type 1 diabetes. These scores showed modest but statistically significant associations with measures of glucose management (HbA\n                      <jats:sub>1c<\/jats:sub>\n                      and CGM time in range), whereas the relationships with residual beta cell function (C-peptide) were weaker and did not reach significance. The modest size of these effects suggests current PROMs capture only limited aspects of the clinical benefit associated with beta cell preservation. Future research should incorporate psychometric instruments that are specifically adapted for young people using modern diabetes technologies and undergoing disease-modifying therapy, to ensure outcomes are meaningfully represented in early-stage type 1 diabetes trials.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06798-z","type":"journal-article","created":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T11:08:54Z","timestamp":1784286534000},"page":"2759-2773","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Relationship between participant-reported outcomes, residual beta cell function and metabolic parameters in youth with newly diagnosed type 1 diabetes"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3436-422X","authenticated-orcid":false,"given":"Peter N.","family":"Taylor","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wai-Yee","family":"Cheung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joe","family":"Lagorio Price","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Boughton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Bowen-Morris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hayley A.","family":"Hutchings","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie J.","family":"Hanna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Luzio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danijela","family":"Tatovic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish","family":"Marwaha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Fuchs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Lam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John W.","family":"Gregory","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Hovorka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin M.","family":"Dayan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,17]]},"reference":[{"issue":"8","key":"6798_CR1","doi-asserted-by":"publisher","first-page":"2051","DOI":"10.1111\/dom.15071","volume":"25","author":"LM Quinn","year":"2023","unstructured":"Quinn LM, Swaby R, Tatovic D, Narendran P, Besser REJ, Dayan CM (2023) What does the licensing of teplizumab mean for diabetes care? 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BMC Med 22(1):175. https:\/\/doi.org\/10.1186\/s12916-024-03396-x","journal-title":"BMC Med"}],"container-title":["Diabetologia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00125-026-06798-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00125-026-06798-z","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00125-026-06798-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T13:16:32Z","timestamp":1788441392000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00125-026-06798-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,17]]},"references-count":36,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["6798"],"URL":"https:\/\/doi.org\/10.1007\/s00125-026-06798-z","relation":{},"ISSN":["0012-186X","1432-0428"],"issn-type":[{"value":"0012-186X","type":"print"},{"value":"1432-0428","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,17]]},"assertion":[{"value":"15 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 January 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 July 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Some of the data were presented as an abstract at the Association of Physicians of Great Britain and Ireland and Diabetes UK meetings in 2025.","order":1,"name":"Ethics","label":"Acknowledgements","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The datasets analysed during the current study (CLOuD and USTEKID) are available from the corresponding author on reasonable request, subject to trial governance and ethical approvals.","order":2,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"This analysis received no specific funding. CLOuD was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme (14\/23\/09), the Helmsley Charitable Trust (2016PG-T1D045 and 2016PG-T1D046) and JDRF (22-2013-266 and 2-RSC-2019-828-M-N). Additional support for the artificial pancreas work was provided by the NIHR Cambridge Biomedical Research Centre and the NIHR Oxford Biomedical Research Centre. The USTEKID study (project reference 16\/36\/01) was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the NIHR and the Medical Research Council (MRC). The views expressed in this publication are those of the authors and not necessarily those of the MRC, the NIHR or the Department of Health and Social Care. Additional funding for mechanistic laboratory tests for USTEKID has been provided by Breakthrough T1D (formerly JDRF) International awards (3-SRA-2018-629-S-B and 4-SRA-2020-882-S-B). The UK Type 1 Diabetes Consortium supported the USTEKID study via grants from Diabetes UK (19\/0005951 and 15\/0005232) and Breakthrough T1D (formerly JDRF) (3-SRA-2019-774-A-N). The study sponsor was not involved in the design of the study; the collection, analysis, and interpretation of data; writing the report; and did not impose any restrictions regarding the publication of the report.","order":3,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"CB is a member of the editorial board of\n                      Diabetologia\n                      . RH reports having received speaker honoraria from Eli Lilly, Dexcom and Novo Nordisk; receiving license fees from BBraun; patents related to closed loop; being a consultant to Abbott Diabetes Care; and being a director at CamDiab. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","label":"Authors\u2019 relationships and activities","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"JWG and CMD conceived the study, PNT and W-YC performed the analyses and PNT drafted the initial manuscript. JLP, CB, JB-M, HAH, SJH, SL, DT, AM, JF, AL and RH contributed to trial design, data collection, analysis oversight and drafting of the manuscript. All authors critically revised the manuscript for important intellectual content and approved the final version for submission. PNT is the guarantor of this work.","order":5,"name":"Ethics","label":"Contribution statement","group":{"name":"EthicsHeading","label":"Ethics"}}]}}