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We aimed to assess whether using enhanced processing to determine indices of insulin secretion and sensitivity is analytically robust, reproducible in a different population, and useful diagnostically and prognostically in clinical practice.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>A total of 1308 pregnant women with one or more risk factors for GDM who underwent a 75 g OGTT at one of nine hospital sites were recruited to this observational study. Specimens were collected for determination of glucose levels using standard and enhanced procedures, HbA<jats:sub>1c<\/jats:sub> and insulin analysis. GDM diagnosis and management followed National Institute for Health and Care Excellence guidance. We categorised women into pathophysiological subtypes: insulin-resistant GDM (HOMA2-S &lt; 25th centile of the population with normal glucose tolerance [NGT]), insulin-insufficient GDM (HOMA2-B &lt; 25th centile), both or neither. We assessed associations with pregnancy outcomes using logistic regression.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Using enhanced specimen handling, 1027\/1308 (78.5%) women had NGT, with 281\/1308 (21.5%) being classified as having GDM. Of this group, 135\/281 (48.0%) had insulin-resistant GDM, 73\/281 (26.0%) had insulin-insufficient GDM and 2\/281 (0.7%) had both insulin-resistant and insulin-insufficient GDM. Unexpectedly, 71 patients (25.3%) had GDM with both HOMA2-S and HOMA2-B \u2265\u00a025th centile (GDM-neither). This novel subgroup appeared to be relatively insulin-sensitive in the fasting state but developed marked post-load hyperglycaemia and hyperinsulinaemia, suggesting an isolated postprandial defect in insulin sensitivity that was not captured by HOMA2-B or HOMA2-S. Women within most GDM subgroups had comparable pregnancy outcomes to those of normoglycaemic women, and HOMA2-B and HOMA2-S were weak predictors of pregnancy outcomes. Maternal BMI predicted a similar number of outcomes to HOMA2-S, suggesting that there was no additional predictive value in adding HOMA2-S. Similar findings were obtained when using different indices and standard specimen handling techniques.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions\/interpretation<\/jats:title>\n            <jats:p>Precision categorisation of GDM using HOMA2-S and HOMA2-B does not provide useful diagnostic or prognostic information, but did distinguish a novel subgroup of patients with GDM, characterised by an isolated postprandial defect in insulin sensitivity.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Graphical Abstract<\/jats:title>\n          <\/jats:sec>","DOI":"10.1007\/s00125-024-06334-x","type":"journal-article","created":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T10:58:04Z","timestamp":1733137084000},"page":"752-765","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A critique of measurement of defective insulin secretion and insulin sensitivity as a precision approach to gestational diabetes"],"prefix":"10.1007","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0372-5579","authenticated-orcid":false,"given":"Danielle L.","family":"Jones","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura C.","family":"Kusinski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clare","family":"Gillies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4176-8329","authenticated-orcid":false,"given":"Claire L.","family":"Meek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,12,2]]},"reference":[{"issue":"10","key":"6334_CR1","doi-asserted-by":"publisher","first-page":"2438","DOI":"10.1038\/s41591-023-02502-5","volume":"29","author":"DK Tobias","year":"2023","unstructured":"Tobias DK, Merino J, Ahmad A et al (2023) Second international consensus report on gaps and opportunities for the clinical translation of precision diabetes medicine. 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The research midwives and nurses who assisted with this study were supported by the NIHR Clinical Research Network (CRN Eastern). This research was supported by the NIHR Cambridge BRC through the Core Biochemistry Assay Laboratory and by the NIHR Leicester BRC. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. This study was presented as a poster at the 84th Scientific Sessions of the American Diabetes Association, 21\u201324 June 2024, Orlando, Florida, USA, and as an oral presentation at the Diabetes in Pregnancy Study Group 56th Annual Meeting, 5\u20137 September 2024, \u00d6rebro, Sweden.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Acknowledgements"}},{"value":"Data are available from the corresponding author upon request, subject to approval from the sponsor and study steering committee.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"The OPHELIA study was funded by a European Foundation for the Study of Diabetes\/Sanofi innovative outcomes project (2017; OPHELIA pilot study). CLM is supported by Diabetes UK through an intermediate clinical fellowship (17\/0005712) and by European Foundation for the Study of Diabetes\/Novo Nordisk Foundation Future Leader\u2019s Award NNF19SA058974. The funding bodies did not play a role in the design or conduct of the research study. This research was supported by the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester Diabetes Centre, University of Leicester, the NIHR Cambridge Biomedical Research Centre (BRC), the Core Biochemical Assay Laboratory (CBAL) and the Core Metabolomic and Lipidomic Laboratory (CMAL). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' relationships and activities"}},{"value":"CLM was responsible for the conceptualisation, design and methodology of the study and for data analysis, and wrote and revised the final report. DLJ was responsible for study coordination, database management, data analysis, and revising several drafts of the manuscript including the final version. LCK supported data collection, study coordination and revised several drafts of the manuscript and the final report. CG provided statistical support and advice and reviewed the various drafts and the final version of the manuscript. Funding for this study was obtained by CLM, who is the guarantor of this study. CLM takes full responsibility for the work as a whole, including the study design, access to data, and the decision to submit and publish the manuscript. All authors reviewed and approved the final version before submission.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Contribution statement"}}]}}