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Helmsley Charitable Trust","award":["2016PG-T1D020"],"award-info":[{"award-number":["2016PG-T1D020"]}],"id":[{"id":"https:\/\/ror.org\/011x6n313","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Leona M. and Harry B. Helmsley Charitable Trust","award":["2017PG-T1D023"],"award-info":[{"award-number":["2017PG-T1D023"]}],"id":[{"id":"https:\/\/ror.org\/011x6n313","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Leona M. and Harry B. Helmsley Charitable Trust","award":["G-1911\u20133274"],"award-info":[{"award-number":["G-1911\u20133274"]}],"id":[{"id":"https:\/\/ror.org\/011x6n313","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Helmholtz Zentrum M\u00fcnchen - Deutsches Forschungszentrum f\u00fcr Gesundheit und Umwelt (GmbH)","id":[{"id":"https:\/\/ror.org\/00cfam450","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diabetologia"],"published-print":{"date-parts":[[2026,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims\/hypothesis<\/jats:title>\n                    <jats:p>The aim of the study was to evaluate the ability of the FreeStyle Libre Pro iQ continuous glucose monitoring (CGM) system to discriminate between presymptomatic stages of type 1 diabetes and stratify progression to stage 3 type 1 diabetes. The study also aimed to compare the performance of the FreeStyle Libre Pro iQ with that of the Dexcom G6.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>From December 2023 to December 2025, 50 children and adolescents without islet autoantibodies (control participants) and 89 with early-stage (stage 1 or 2) type 1 diabetes underwent CGM with the FreeStyle Libre Pro iQ. Participants with early-stage type 1 diabetes were followed up for the development of stage 3 clinical type 1 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      CGM data were unavailable or incomplete for 13 participants (9%), leaving 126 (91%) for analysis (73 female, median age 10.0 years [IQR 7.9\u201312.8]). The CGM parameters used\u2014namely the SD, CV, time with glucose levels above 7.8 mmol\/l (140 mg\/dl; TA140) and 8.9 mmol\/l (160 mg\/dl; TA160) and time in tight range\u2014differed significantly across participants with no early-stage, stage 1 or stage 2 type 1 diabetes, and between participants with a single dysglycaemia abnormality and those with multiple dysglycaemia abnormalities. One or more of these parameters exceeded the 97.5th percentile of control values in 10 (22%) of the 45 individuals with stage 1 type 1 diabetes and in 13 (52%) of the 25 individuals with stage 2 type 1 diabetes (\n                      <jats:italic>p<\/jats:italic>\n                      =0.017). Two or more of the parameters exceeded the 97.5th percentile threshold in six (13%) of the individuals with stage 1 type 1 diabetes and 11 (44%) of the individuals with stage 2 type 1 diabetes (\n                      <jats:italic>p<\/jats:italic>\n                      =0.0077). The 97.5th percentile threshold for TA140 (i.e. &gt;15%) was exceeded by none of the 45 individuals with stage 1 type 1 diabetes, 10 (40%) of the 25 individuals with stage 2 type 1 diabetes and six of the eight individuals who progressed to clinical diabetes within 1 year, identifying these individuals as rapid progressors. FreeStyle Libre Pro iQ values differed markedly from those previously observed using the Dexcom G6 in a similar cohort. Using the 97.5th percentile of values of control individuals to define CGM abnormalities enabled harmonisation across systems and supported the consistent identification of high-risk individuals. With this approach, the sensitivity for identifying those who progressed to clinical diabetes within 1 year ranged from 75% to 100% for the FreeStyle Libre Pro iQ and from 50% to 100% for the Dexcom G6.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>These findings support CGM as a promising tool for staging and risk stratification in early-stage type 1 diabetes, while highlighting the need for system-specific interpretation before use in therapeutic decision-making.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06852-w","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T13:48:43Z","timestamp":1788788923000},"page":"3512-3522","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Continuous glucose monitoring using the FreeStyle Libre Pro iQ in presymptomatic type 1 diabetes"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9597-0576","authenticated-orcid":false,"given":"Andreas","family":"Weiss","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4431-5883","authenticated-orcid":false,"given":"Elisabeth","family":"Huber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franziska","family":"Reinm\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette","family":"Munzinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8704-4713","authenticated-orcid":false,"given":"Ezio","family":"Bonifacio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6290-5548","authenticated-orcid":false,"given":"Anette-Gabriele","family":"Ziegler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,7]]},"reference":[{"issue":"7","key":"6852_CR1","doi-asserted-by":"publisher","first-page":"1169","DOI":"10.1007\/s00125-023-05927-2","volume":"66","author":"AG Ziegler","year":"2023","unstructured":"Ziegler AG (2023) The countdown to type 1 diabetes: when, how and why does the clock start? 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Diabetologia 69(6):1413\u20131431. https:\/\/doi.org\/10.1007\/s00125-026-06707-4","journal-title":"Diabetologia"}],"container-title":["Diabetologia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00125-026-06852-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00125-026-06852-w","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00125-026-06852-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T13:53:54Z","timestamp":1793109234000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00125-026-06852-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,7]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2026,12]]}},"alternative-id":["6852"],"URL":"https:\/\/doi.org\/10.1007\/s00125-026-06852-w","relation":{},"ISSN":["0012-186X","1432-0428"],"issn-type":[{"value":"0012-186X","type":"print"},{"value":"1432-0428","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,7]]},"assertion":[{"value":"30 April 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 June 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 September 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The authors are grateful to the participating families and children and all members of the Fr1da study team. We also thank all primary care paediatricians and clinical centres participating in the Fr1da study group, as well as E. Bonnin (Institute for Diabetes Research, Helmholtz Munich) for supporting the manuscript submission.","order":1,"name":"Ethics","label":"Acknowledgements","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"All datasets generated and analysed during the current study are not publicly available but are available from the corresponding author on reasonable request. Requests should include a project description outlining the proposed use of the data and the scientific rationale. Data access is subject to completion of a data use agreement with Helmholtz Munich.","order":2,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"Open Access funding enabled and organized by Projekt DEAL. This study was supported by a grant from the EASD-Novo Nordisk Foundation Diabetes Prize for Excellence (NNF22SA0081044) and the German Center for Diabetes Research (DZD e.V.). Both sensor systems, namely the FreeStyle Libre Pro iQ and previously the Dexcom G6, were purchased using institutional funds from Helmholtz Munich. The Fr1da study was supported by Breakthrough T1D (formerly Juvenile Diabetes Research Foundation International: 1-SRA-2014-310-M-R, 3-SRA-2019-718-Q-R, 3-SRA-2015\u201372-M-R, 3-SRA-2026-1795-S-B), LifeScience Stiftung (HMGU 2014.01 and HMGU 2016.01), the Leona M. and Harry B. Helmsley Charitable Trust (G-1911-3274, 2017PG-T1D023, 2016PG-T1D020), the Deutsche Diabetiker Bund e.V. and the Bavarian Ministry of Economic Affairs, Energy, and Technology (Digital Lab). The funding sources were not involved in the design or conduct of the study or the decision to submit the manuscript for publication.","order":3,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"A-GZ served as a member of advisory boards for Sanofi-Aventis and Novo Nordisk and received support to give lectures sponsored by Sanofi-Aventis. EB received support for travel and accommodation to attend international conferences and to give lectures sponsored by Sanofi-Aventis. 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":"A-GZ was the principal investigator and designed the study. AW and EB performed the statistical analysis. A-GZ, EB, AW and EH drafted the manuscript. All authors acquired data, contributed to the interpretation of data and critically reviewed the manuscript. All authors reviewed and approved the manuscript for publication. A-GZ is the guarantor of this work and, as such, has full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.","order":5,"name":"Ethics","label":"Contribution statement","group":{"name":"EthicsHeading","label":"Ethics"}}]}}