{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T17:28:28Z","timestamp":1789752508683,"version":"4.0.1"},"reference-count":51,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2024,12,21]],"date-time":"2024-12-21T00:00:00Z","timestamp":1734739200000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National Health and Medical Research Council of Australia","award":["APP1099379"],"award-info":[{"award-number":["APP1099379"]}]},{"DOI":"10.13039\/501100001067","name":"Juvenile Diabetes Research Foundation Australia","doi-asserted-by":"publisher","award":["5-ECR-2017-371-A-N"],"award-info":[{"award-number":["5-ECR-2017-371-A-N"]}],"id":[{"id":"10.13039\/501100001067","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100020647","name":"Diabetes Victoria","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100020647","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000971","name":"Diabetes Australia","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100000971","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001782","name":"University of Melbourne","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100001782","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004365","name":"Sydney Medical School","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100004365","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100017012","name":"Roche Diabetes Care","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100017012","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000901","name":"Juvenile Diabetes Research Foundation International","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/100000901","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001778","name":"Deakin University","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100001778","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Medtronic","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}]},{"name":"JDRF Australian Type 1 Diabetes Clinical Research Network","award":["3-SRA-2016-351-M-B"],"award-info":[{"award-number":["3-SRA-2016-351-M-B"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Diab Res Care"],"accepted":{"date-parts":[[2024,10,13]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Research design and methods<\/jats:title>\n                    <jats:p>In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed\u2122 670G) or standard therapy (insulin pump or multiple daily injections without real-time continuous glucose monitoring). Psychological outcomes (awareness and fear of hypoglycemia; and diabetes-specific positive well-being, diabetes distress, diabetes treatment satisfaction, and diabetes-specific quality of life (QoL)) were measured at enrollment, mid-trial and end-trial. Linear mixed models were conducted, using restricted maximum likelihood estimation, unadjusted and adjusted (for covariates: age, sex, diabetes duration, glycated hemoglobin, recent severe hypoglycemia, pre-trial insulin delivery modality, enrollment and mid-study scores).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>120 participants (mean age 44\u00b112 years) were randomized to intervention (n=61) or standard therapy (n=59). At 13 weeks, the HCL group had better diabetes-specific positive well-being than the standard therapy group (unadjusted: \u0394=1.0, p=0.025; adjusted: \u0394=1.1, p=0.01), which was maintained at 26 weeks (unadjusted: \u0394=0.9, p=0.042; adjusted: \u0394=1.0, p=0.023). At 26 weeks, the HCL group also had less diabetes distress (adjusted: \u0394=\u22126.4, p=0.039), fear of hypoglycemia (\u201cmaintain high\u201d: adjusted: \u0394=\u22120.8, p=0.034; and \u201cworry\u201d: adjusted: \u0394=\u22121.8, p=0.048), and perceived \u201cunacceptably high glucose levels\u201d (unadjusted: \u0394=\u22121.1, p&lt;0.001; adjusted: \u0394=\u22121.1, p&lt;0.001). HCL did not improve diabetes treatment satisfaction, diabetes-specific QoL, hypoglycemia awareness, or perceived frequency of unacceptably low glucose levels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings imply that HCL offers important psychological benefits. In particular, improvement in diabetes-specific positive well-being was observed 13 weeks after HCL initiation and maintained at 26 weeks. Reduction in the perceived frequency of hyperglycemia was also apparent by 26 weeks. Adjusted analyses showed significant reductions in diabetes distress and fear of hypoglycemia at 26 weeks, suggesting these benefits were apparent for people with particular characteristics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>Australian New Zealand Clinical Trials Registry: ACTRN12617000520336.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjdrc-2024-004428","type":"journal-article","created":{"date-parts":[[2024,12,26]],"date-time":"2024-12-26T11:13:34Z","timestamp":1735211614000},"page":"e004428","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Six months of hybrid closed-loop therapy improves diabetes-specific positive well-being, and reduces diabetes distress and fear of hypoglycemia: secondary analysis of a randomized controlled trial"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1156-279X","authenticated-orcid":false,"given":"Jennifer A","family":"Halliday","sequence":"first","affiliation":[{"name":"Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia"},{"name":"The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, Australia"},{"name":"School of Psychology, Deakin University, Geelong, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sienna","family":"Russell-Green","sequence":"additional","affiliation":[{"name":"The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, Australia"},{"name":"School of Psychology, Deakin University, Geelong, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Lam","sequence":"additional","affiliation":[{"name":"The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, Australia"},{"name":"School of Psychology, Deakin University, Geelong, Victoria, Australia"},{"name":"Education Futures, University of South Australia, Adelaide, South Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Trawley","sequence":"additional","affiliation":[{"name":"The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, Australia"},{"name":"School of Psychology, Deakin University, Geelong, Victoria, Australia"},{"name":"The Cairnmillar Institute, Melbourne, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7035-489X","authenticated-orcid":false,"given":"Sybil A","family":"McAuley","sequence":"additional","affiliation":[{"name":"The Cairnmillar Institute, Melbourne, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Endocrinology and Diabetes, St Vincent\u2019s Hospital Melbourne, Fitzroy, Victoria, Australia"},{"name":"School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia"},{"name":"Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leon A","family":"Bach","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia"},{"name":"School of Translational Medicine, Monash University, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morton G","family":"Burt","sequence":"additional","affiliation":[{"name":"Southern Adelaide Diabetes and Endocrine 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Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A","family":"Davis","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Western Australia, Australia"},{"name":"School of Paediatrics and Child Health, The University of Western Australia, Perth, Tasmania, Australia"},{"name":"Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3640-1370","authenticated-orcid":false,"given":"Deborah Jane","family":"Holmes-Walker","sequence":"additional","affiliation":[{"name":"Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia"},{"name":"Department of Diabetes and Endocrinology, Westmead Hospital, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia J","family":"Jenkins","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Endocrinology and Diabetes, St Vincent\u2019s Hospital Melbourne, Fitzroy, Victoria, Australia"},{"name":"NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joey","family":"Kaye","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony C","family":"Keech","sequence":"additional","affiliation":[{"name":"NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa H","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Endocrinology and Diabetes, St Vincent\u2019s Hospital Melbourne, Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland W","family":"McCallum","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbora","family":"Paldus","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Endocrinology and Diabetes, St Vincent\u2019s Hospital Melbourne, Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen 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