Hybrid 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.

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dc.contributor.authorBoughton, Charlotte K
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 L
dc.contributor.authorHovorka, Roman
dc.contributor.departmentResearch and Developmenten_US
dc.contributor.departmentDiabetesen_US
dc.contributor.roleMedical and Dentalen_US
dc.contributor.trustauthorDraxlbauer, Katharine
dc.contributor.trustauthorNarendran, Parth
dc.date.accessioned2024-06-20T15:19:18Z
dc.date.available2024-06-20T15:19:18Z
dc.date.issued2022-03-07
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 ClinicalTrials.gov 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.en_US
dc.identifier.citationBoughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Wilinska ME, Hood KK, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R. Hybrid 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. Lancet Healthy Longev. 2022 Mar;3(3):e135-e142. doi: 10.1016/S2666-7568(22)00005-8. Epub 2022 Mar 7en_US
dc.identifier.doi10.1016/S2666-7568(22)00005-8
dc.identifier.eissn2666-7568
dc.identifier.pmid35359882
dc.identifier.urihttp://hdl.handle.net/20.500.14200/4922
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.urlhttps://www.thelancet.com/journals/lanhl/homeen_US
dc.source.beginpagee135
dc.source.countryUnited Kingdom
dc.source.countryUnited States
dc.source.countryUnited Kingdom
dc.source.countryEngland
dc.source.endpagee142
dc.source.issue3
dc.source.journaltitleThe Lancet Healthy Longevityen_US
dc.source.volume3
dc.subjectEndocrinologyen_US
dc.subjectDiabetesen_US
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.en_US
dc.typeArticleen_US
dc.typeOtheren_US
dspace.entity.typePublication
oa.grant.openaccessnaen_US
rioxxterms.versionNAen_US
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