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dc.contributor.authorBoughton, Charlotte
dc.contributor.authorHartnell, Sara
dc.contributor.authorThabit, Hood
dc.contributor.authorMubita, Womba M
dc.contributor.authorDraxlbauer, Katharine
dc.contributor.authorPoettler, Tina
dc.contributor.authorWilinska, Malgorzata E
dc.contributor.authorHood, Korey K
dc.contributor.authorMader, Julia K
dc.contributor.authorNarendran, Parth
dc.contributor.authorLeelarathna, Lalantha
dc.contributor.authorEvans, Mark
dc.contributor.authorHovorka, Roman
dc.description.abstractBackground: Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes. Methods: In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at NCT04025762. Findings: 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA1c]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period. Interpretation: Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.
dc.description.sponsorshipThis work was funded by the National Institute of Diabetes and Digestive and Kidney Diseases under the grant number 1DP3DK112176-01. Additional support for the artificial pancreas work from National Institute for Health Research Cambridge Biomedical Research Centre, and JDRF. Dexcom supplied discounted continuous glucose monitoring devices. The views expressed are those of the author(s) and not necessarily those of the funders.
dc.publisherElsevier BV
dc.rightsAttribution 4.0 International
dc.titleHybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.
dc.publisher.departmentDepartment of Clinical Biochemistry
dc.publisher.departmentDepartment of Paediatrics
prism.publicationNameLancet Healthy Longev
dc.contributor.orcidBoughton, Charlotte [0000-0003-3272-9544]
dc.contributor.orcidEvans, Mark [0000-0001-8122-8987]
dc.contributor.orcidHovorka, Roman [0000-0003-2901-461X]
rioxxterms.typeJournal Article/Review
pubs.funder-project-idNational Institute of Diabetes and Digestive and Kidney Diseases (DP3DK112176)
pubs.funder-project-idCambridge University Hospitals NHS Foundation Trust (CUH) (146281)
cam.orpheus.successWed Mar 23 10:26:29 GMT 2022 - Embargo updated
pubs.licence-display-nameApollo Repository Deposit Licence Agreement

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