{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T12:07:41Z","timestamp":1784635661824,"version":"3.55.0"},"reference-count":29,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2025,4,12]],"date-time":"2025-04-12T00:00:00Z","timestamp":1744416000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,4,12]],"date-time":"2025-04-12T00:00:00Z","timestamp":1744416000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Glyconics Ltd"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Current diabetes screening methods are complex, inefficient, and inconvenient, requiring resource-intensive blood sampling. With the increasing prevalence of underdiagnosed type 2 diabetes mellitus (T2DM) worldwide, particularly in low-resource settings and underserved populations, affordable and sustainable mass-screening tools are crucial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      The accuracy and safety of the miniaturized near-infrared (NIR), full-spectrum spectroscopy Glyconics-DS System in detecting T2DM risk status was assessed by pooling data from two independent pilot studies: ANODE01 and ANODE02. Rapid NIR assessments of glycated nail keratin in 60 repeated spectral readings of fingernails from individuals with or without T2DM focused on detecting dichotomized diabetes risk status (glycated hemoglobin [HbA\n                      <jats:sub>1c<\/jats:sub>\n                      ] &lt;6.5%) based on chemometric prediction models, clinical specificity\/sensitivity, and true\/false positive outcomes. An HbA\n                      <jats:sub>1c<\/jats:sub>\n                      point-of-care assay served as an internal control.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Over 12\u2009000 NIR spectral readings were collected in a female-dominant (58.5%), mostly non-smoking (80.0%), diverse cohort of 200 participants (n = 100 with\/n = 100 without T2D). The selected chemometrics prediction model on a diagnostic HbA\n                      <jats:sub>1c<\/jats:sub>\n                      cut-off of 6.5% showed a specificity of 92.9% (95% confidence interval [CI] = 88.5-97.4) and a sensitivity of 34.2% (95% CI = 23.4-45.1), with 71.5% concordance. Chemometric predictions were consistent and reproducible with no relevant impact of anthropometric variables, concomitant conditions\/medications, smoking status, and number of spectral assessments\/nail or hand dominance on NIR assessment. No adverse events or suspected de novo T2D cases were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This pooled analysis of two independent studies demonstrates the clinical feasibility and high specificity of rapid NIR spectral assessment of T2DM risk, with potential for screening, early detection, and sustainable management across health care settings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/19322968251331069","type":"journal-article","created":{"date-parts":[[2025,4,12]],"date-time":"2025-04-12T06:13:01Z","timestamp":1744438381000},"page":"1313-1321","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Use of a Miniaturized Near-Infrared Spectroscopy Device for Type 2 Diabetes Mellitus Screening: Pooled Analysis of the Pilot ANODE01 and ANODE02 Studies"],"prefix":"10.1177","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7635-4735","authenticated-orcid":false,"given":"Pratik","family":"Choudhary","sequence":"first","affiliation":[{"name":"Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e4ivi M.","family":"Pald\u00e1nius","sequence":"additional","affiliation":[{"name":"Research Program for Clinical and Molecular Metabolism, Children\u2019s Hospital, University of Helsinki, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John E.","family":"Salter","sequence":"additional","affiliation":[{"name":"Teslar Consulting Ltd, Chippenham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0100-9416","authenticated-orcid":false,"given":"Daniela","family":"Lazaro-Pacheco","sequence":"additional","affiliation":[{"name":"Glyconics Ltd, Basingstoke, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesc Xavier","family":"Cos Claramunt","sequence":"additional","affiliation":[{"name":"Sant Mart\u00ed de Proven\u00e7als Primary Healthcare Centre, Barcelona, Spain"},{"name":"IDIAP Jordi Gol Primary Care Research Institute, Barcelona, Spain"},{"name":"Center for Biomedical Research on Diabetes and Associated Metabolic Diseases, Instituto de Salud Carlos III, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,4,12]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)02317-1"},{"key":"e_1_3_3_3_2","unstructured":"World Health Organization. WHO factsheets diabetes. Accessed February 14 2025. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/diabetes"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2021.109119"},{"key":"e_1_3_3_5_2","unstructured":"International Diabetes Federation (IDF). IDF Diabetes Atlas 10th Edition. Brussels Belgium: 2022. https:\/\/diabetesatlas.org\/resources\/idf-diabetes-atlas-2025\/"},{"key":"e_1_3_3_6_2","unstructured":"Centers for Disease Control and Prevention (CDC). National diabetes statistics report. Estimates of diabetes and its burden in the United States. Published 2023. Accessed February 14 2025. https:\/\/stacks.cdc.gov\/view\/cdc\/148231"},{"key":"e_1_3_3_7_2","article-title":"Burden of illness in type 2 diabetes mellitus","volume":"24","author":"Cannon A","year":"2018","unstructured":"Cannon A, Handelsman Y, Heile M, Shannon M. Burden of illness in type 2 diabetes mellitus. J Manag Care Spec Pharm. 2018;24(9-a suppl):S5-S13.","journal-title":"J Manag Care Spec Pharm"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-020-00791-4"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1186\/1475-9276-13-43"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.2337\/cd21-0039"},{"key":"e_1_3_3_11_2","article-title":"2. Diagnosis and classification of diabetes: standards of care in diabetes\u20142025","volume":"48","author":"American Diabetes Association Professional Practice Committee","year":"2025","unstructured":"American Diabetes Association Professional Practice Committee. 2. Diagnosis and classification of diabetes: standards of care in diabetes\u20142025. Diabetes Care. 2025;48(suppl 1):S27-S49.","journal-title":"Diabetes Care"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11892-022-01453-4"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.2337\/cd17-0049"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2020.07.009"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjdrc-2021-002423"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-1010-5"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2012.12.009"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-323-91249-5.00016-8"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0120112"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1177\/1932296815608980"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2018-0239"},{"issue":"1","key":"e_1_3_3_22_2","first-page":"1","article-title":"Keratin intrinsic fluorescence as a mechanism for non-invasive monitoring of its glycation","volume":"11","author":"Muir R","year":"2022","unstructured":"Muir R, Forbes S, Birch DJS, Vyshemirsky V, Rolinski OJ. Keratin intrinsic fluorescence as a mechanism for non-invasive monitoring of its glycation. Methods Appl Fluoresc. 2022;11(1):1-12.","journal-title":"Methods Appl Fluoresc"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2024.120036"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinbiochem.2016.09.001"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1111\/tmi.12218"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1364\/BOE.520102"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.3109\/08958378.2014.955932"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.2337\/dci22-0034"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-65649-6_5"},{"key":"e_1_3_3_30_2","volume-title":"Poster #PP02. Paper presented at the 13th International Conference on Clinical Spectroscopy (SPEC2024)","author":"Lazaro-Pacheco D","unstructured":"Lazaro-Pacheco D, Taday PF, Pald\u00e1nius PM. Setting the standard: quality control techniques in the \u201cDIRTY\u201d sub-study of nail infrared spectra for clinical screening. Poster #PP02. 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