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We aimed to compare feasibility, safety and efficacy of automated insulin delivery (AID) with usual care in people with diabetes and advanced CKD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a prospective, open-label, randomised crossover trial at five tertiary hospitals in Australia and one tertiary centre in Denmark. Adults aged \u226518 years with type 1 diabetes or insulin-treated type 2 diabetes and advanced CKD (stage 3b or higher, including dialysis) were eligible. Participants were randomly assigned in a 1:1 sequence to receive either AID followed by usual care with real-time continuous glucose monitoring (CGM), or the reverse sequence, each for 8 weeks. Allocation was generated centrally using computerised randomisation. Due to the nature of the intervention, participants and clinicians were aware of treatment assignment. The primary outcome was percentage time in range (3.9\u201310.0 mmol\/l) during the final 3 weeks of each treatment period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Forty participants (24 type 1 diabetes, 16 type 2 diabetes; median [IQR] age 60 [55, 69] years; HbA\n                      <jats:sub>1c<\/jats:sub>\n                      64 [54, 73] mmol\/mol [8.0% (7.1%, 8.8%)]; eGFR 30 [18, 37] ml\/min per 1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      ) were enrolled: 33 not on dialysis, four on peritoneal dialysis and three on haemodialysis. AID significantly improved all hyperglycaemic CGM metrics compared with usual care. Time in range (3.9\u201310.0 mmol\/l) improved from 60% (51%, 66%) at the end of usual care to 73% (65%, 78%) at the end of AID (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001). Hypoglycaemia rates were unchanged. Participants were predominantly pre-frail at baseline and remained stable on-trial. No serious adverse events were attributed to the study devices. Nonetheless, 25% of participants experienced hospital admissions during the trial period for medical issues unrelated to device use.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>AID is feasible and safe and compared with usual care provides superior glucose management in predominantly pre-frail people with diabetes complicated by advanced CKD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>Australian New Zealand Clinical Trials Registry ACTRN12622000889752; ClinicalTrials.gov NCT06330194<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>This trial was funded by the Australian Centre for Advancing Diabetes Innovations (ACADI), St Vincent\u2019s Hospital Melbourne and Diabetes Australia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06732-3","type":"journal-article","created":{"date-parts":[[2026,5,10]],"date-time":"2026-05-10T23:13:11Z","timestamp":1778454791000},"page":"2168-2181","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease"],"prefix":"10.1007","volume":"69","author":[{"given":"Jean C.","family":"Lu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine L.","family":"Meyer-Olesen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bella","family":"Halim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Vogrin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merete B.","family":"Christensen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Apostolopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Bomholt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard J.","family":"MacIsaac","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petrova","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Trawley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neale","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Spiros","family":"Fourlanos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Stranks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia J.","family":"Jenkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elif","family":"Ekinci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mads","family":"Hornum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirsten","family":"N\u00f8rgaard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David N.","family":"O\u2019Neal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,11]]},"reference":[{"key":"6732_CR1","unstructured":"European Renal Association Registry (2023) ERA Registry Annual Report 2023. 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The authors also thank the trial nurses, diabetes educators and dietitians at the clinical sites for their support; lead site diabetes educator S. Double (St Vincent\u2019s Hospital Melbourne, Fitzroy, Victoria, Australia); lead site dietitian S. Flint (St Vincent\u2019s Hospital Melbourne, Fitzroy, Victoria, Australia); diabetes nurse specialist K. Rytter (Steno Diabetes Center Copenhagen, Herlev, Denmark); and dietitian C. Frydenberg (Steno Diabetes Center Copenhagen, Herlev, Denmark). We would also like to acknowledge the valuable discussions and insights provided by L. Leelarathna (Imperial College London, UK). Some of the data were presented as an abstract at the European Association for the Study of Diabetes (EASD) annual meeting in September 2025.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Acknowledgements"}},{"value":"Data are available from the corresponding author on reasonable request, subject to institutional data-sharing policies and ethical approval.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Open Access funding enabled and organized by CAUL and its Member Institutions. This trial was funded by the Australian Centre for Advancing Diabetes Innovations (ACADI), St Vincent\u2019s Hospital Melbourne and Diabetes Australia. Support was provided by Medtronic (AID systems, CGM devices and technical expertise with device issues). ACADI provided input into the trial design. The funders of the trial had no role in data collection, data analysis, data interpretation, or writing of the report. Steno Diabetes Center Copenhagen received an unrestricted grant from Medtronic.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"JCL, CLM-O, BH, SV, MBC, JA, PL, ST and SS declare that there are no relationships or activities that might bias, or be perceived to bias, their work. TB has served as an advisory board member for Medtronic and AstraZeneca and has also been a speaker and lecturer for AstraZeneca and Boehringer Ingelheim. He has also received research grant support from Novo Nordisk. RJM has received research grants from Novo Nordisk, Servier, Medtronic, The Rebecca Cooper Medical Research Foundation, St Vincent\u2019s Research Foundation, Breakthrough T1D, Grey Innovations, The Diabetes Australia Research Trust\/Program and The National Health and Medical Research Council of Australia. He has also received honoraria for lectures from Eli Lilly, Novo Nordisk, Sanofi Aventis, AstraZeneca, Merck Sharp & Dohme, Novartis and Boehringer Ingelheim, and has been or is on the advisory boards for Novo Nordisk, Boehringer Ingelheim-Eli Lilly Diabetes Alliance, AstraZeneca and Merck Sharp & Dohme. Travel support has been supplied by Novo Nordisk, Sanofi, Boehringer Ingelheim and AstraZeneca. He has been a principal investigator for industry-sponsored clinical trials run by Novo Nordisk, Sanofi, Bayer, Johnson-Cilag and AbbVie. He has been an investigator on industry-sponsored trials involving liraglutide, semaglutide, canagliflozin, sotagliflozin and finerenone. NC has received research and\/or advisory board support from Ypsomed, Novo Nordisk, Medtronic, Endogenex, Telematics Trust, Roche and Abbott. SF reports no direct conflicts of interest to the work reported. He has received a research grant from Dexcom and has speaker fee honoraria for AstraZeneca, Boehringer Ingelheim, Lilly and Novo Nordisk, and adviser fee honoraria for Medtronic, Mylan, Pfizer and Sanofi. He has been a principal investigator for industry-sponsored clinical trials run by Novo Nordisk and Boehringer Ingelheim. EE\u2019s institution has received research funding from Novo Nordisk, Eli Lilly, AstraZeneca, Versanis, Endogenex, Novartis and Abbott for unrelated research. AJJ has received research support from Medtronic, Sanofi, Abbott Laboratories and Mylan, and has served on advisory boards for Medtronic, Sanofi and Abbott Diabetes Care. MH has served on scientific advisory boards for these companies outside the scope of this study: AstraZeneca, Novo Nordisk, Boehringer Ingelheim, GSK and CSL Vifor Pharma. He has served as a moderator at symposia and educational meetings for AstraZeneca and Novo Nordisk. Furthermore, he has received research grants from the A.P. M\u00f8ller Foundation, Per Henriksen Foundation, Augustinus Foundation, Helen Bj\u00f8rnow Foundation and Lundbeck Foundation. He has also received a Twinning Horizon 2020 Europe Grant and a HALRIC EU grant. KN serves as an adviser to Abbott Diabetes Care, Convatec, Medtronic, Novo Nordisk and Tandem; owns stocks in Novo Nordisk; has received research grants to her institution from Dexcom, Medtronic, Novo Nordisk and Zealand Pharma; and has received fees for speaking from Medtronic and Novo Nordisk. DNO has received honoraria from Medtronic, Insulet, Abbott Diabetes Care, Novo Nordisk and Sanofi, and research support from Medtronic, Insulet, Dexcom, Roche, GlySens, BioCapillary and Endogenex, and is on advisory boards for Medtronic, Insulet, Abbott Diabetes Care, Ypsomed, Novo Nordisk and Sanofi.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' relationships and activities"}},{"value":"JCL performed part of the primary data collection, researched the data and wrote the manuscript. CLM-O performed part of the primary data collection, researched the data, and reviewed and edited the manuscript. MBC and KN researched the data, contributed to the interpretation of the results and reviewed the manuscript. SV performed the statistical analyses and contributed to interpretation of the data and discussion. All other authors contributed to the conception and design of the study and\/or acquisition and interpretation of the data, critically reviewed the manuscript for important intellectual content and approved the final version of the manuscript. DNO is the guarantor of this work and, as such, had full access to all 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","group":{"name":"EthicsHeading","label":"Contribution statement"}}]}}