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
Introduction This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.Research design and methods In this multicenter, open-label, randomized, controlled, parallel-group clinical trial,...
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open Diabetes Research & Care |
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| author | Anthony C Keech Vijaya Sundararajan Bruce R King Sara Vogrin Richard J MacIsaac Leon A Bach Jane Speight Alicia J Jenkins Christel Hendrieckx David O’Neal Sybil A McAuley Geoff R Ambler Fergus J Cameron Jan M Fairchild Elizabeth A Davis Timothy W Jones Morton G Burt Philip M Clarke Neale D Cohen Peter G Colman Joey Kaye Kavita Kumareswaran Melissa H Lee Roland W Mccallum Barbora Paldus Stephen N Stranks Steven Trawley Glenn M Ward David N O’Neal Sienna Russell-Green Deborah Jane Holmes-Walker Benjamin Lam Jennifer A Halliday Glenn Ward Catriona M Sims D Jane Holmes-Walker Andrzej Januszewski Hanafi Mohammed Husin Martin I de Bock Mary B Abraham |
| author_facet | Anthony C Keech Vijaya Sundararajan Bruce R King Sara Vogrin Richard J MacIsaac Leon A Bach Jane Speight Alicia J Jenkins Christel Hendrieckx David O’Neal Sybil A McAuley Geoff R Ambler Fergus J Cameron Jan M Fairchild Elizabeth A Davis Timothy W Jones Morton G Burt Philip M Clarke Neale D Cohen Peter G Colman Joey Kaye Kavita Kumareswaran Melissa H Lee Roland W Mccallum Barbora Paldus Stephen N Stranks Steven Trawley Glenn M Ward David N O’Neal Sienna Russell-Green Deborah Jane Holmes-Walker Benjamin Lam Jennifer A Halliday Glenn Ward Catriona M Sims D Jane Holmes-Walker Andrzej Januszewski Hanafi Mohammed Husin Martin I de Bock Mary B Abraham |
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| description | Introduction This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.Research design and methods In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed™ 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).Results 120 participants (mean age 44±12 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: Δ=1.0, p=0.025; adjusted: Δ=1.1, p=0.01), which was maintained at 26 weeks (unadjusted: Δ=0.9, p=0.042; adjusted: Δ=1.0, p=0.023). At 26 weeks, the HCL group also had less diabetes distress (adjusted: Δ=−6.4, p=0.039), fear of hypoglycemia (“maintain high”: adjusted: Δ=−0.8, p=0.034; and “worry”: adjusted: Δ=−1.8, p=0.048), and perceived “unacceptably high glucose levels” (unadjusted: Δ=−1.1, p<0.001; adjusted: Δ=−1.1, p<0.001). HCL did not improve diabetes treatment satisfaction, diabetes-specific QoL, hypoglycemia awareness, or perceived frequency of unacceptably low glucose levels.Conclusions 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.Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12617000520336. |
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| institution | OA Journals |
| issn | 2052-4897 |
| language | English |
| publishDate | 2024-12-01 |
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| spelling | doaj-art-97f4a0df78df43928cf0aabb70025c102025-08-20T02:35:57ZengBMJ Publishing GroupBMJ Open Diabetes Research & Care2052-48972024-12-0112610.1136/bmjdrc-2024-004428Six 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 Anthony C Keech0Vijaya Sundararajan1Bruce R KingSara VogrinRichard J MacIsaacLeon A Bach2Jane Speight3Alicia J Jenkins4Christel Hendrieckx5David O’Neal6Sybil A McAuley7Geoff R AmblerFergus J CameronJan M FairchildElizabeth A Davis8Timothy W Jones9Morton G Burt10Philip M ClarkeNeale D Cohen11Peter G Colman12Joey Kaye13Kavita KumareswaranMelissa H Lee14Roland W Mccallum15Barbora Paldus16Stephen N Stranks17Steven Trawley18Glenn M WardDavid N O’NealSienna Russell-Green19Deborah Jane Holmes-Walker20Benjamin Lam21Jennifer A Halliday22Glenn Ward23Catriona M SimsD Jane Holmes-WalkerAndrzej JanuszewskiHanafi Mohammed HusinMartin I de BockMary B AbrahamNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, AustraliaDepartment of Public Health, La Trobe University, Melbourne, Victoria, AustraliaDepartment of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, AustraliaInstitute for Health Transformation, Deakin University, Geelong, Victoria, AustraliaDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, AustraliaThe Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, AustraliaDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, AustraliaDepartment of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, AustraliaDepartment of Endocrinology and Diabetes, Perth Children`s Hospital, Perth, Western Australia, AustraliaDepartment of Endocrinology and Diabetes, Perth Children`s Hospital, Perth, Western Australia, AustraliaSouthern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, AustraliaSchool of Pharmacy, University of Queensland, St Lucia, Queensland, AustraliaDepartment of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, AustraliaDepartment of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Perth, Western Australia, AustraliaDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, AustraliaDepartment of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, AustraliaDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, AustraliaSouthern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, AustraliaThe Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, AustraliaThe Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, AustraliaSydney Medical School, The University of Sydney, Sydney, New South Wales, AustraliaThe Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, AustraliaIntroduction This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.Research design and methods In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed™ 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).Results 120 participants (mean age 44±12 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: Δ=1.0, p=0.025; adjusted: Δ=1.1, p=0.01), which was maintained at 26 weeks (unadjusted: Δ=0.9, p=0.042; adjusted: Δ=1.0, p=0.023). At 26 weeks, the HCL group also had less diabetes distress (adjusted: Δ=−6.4, p=0.039), fear of hypoglycemia (“maintain high”: adjusted: Δ=−0.8, p=0.034; and “worry”: adjusted: Δ=−1.8, p=0.048), and perceived “unacceptably high glucose levels” (unadjusted: Δ=−1.1, p<0.001; adjusted: Δ=−1.1, p<0.001). HCL did not improve diabetes treatment satisfaction, diabetes-specific QoL, hypoglycemia awareness, or perceived frequency of unacceptably low glucose levels.Conclusions 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.Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12617000520336.https://drc.bmj.com/content/12/6/e004428.full |
| spellingShingle | Anthony C Keech Vijaya Sundararajan Bruce R King Sara Vogrin Richard J MacIsaac Leon A Bach Jane Speight Alicia J Jenkins Christel Hendrieckx David O’Neal Sybil A McAuley Geoff R Ambler Fergus J Cameron Jan M Fairchild Elizabeth A Davis Timothy W Jones Morton G Burt Philip M Clarke Neale D Cohen Peter G Colman Joey Kaye Kavita Kumareswaran Melissa H Lee Roland W Mccallum Barbora Paldus Stephen N Stranks Steven Trawley Glenn M Ward David N O’Neal Sienna Russell-Green Deborah Jane Holmes-Walker Benjamin Lam Jennifer A Halliday Glenn Ward Catriona M Sims D Jane Holmes-Walker Andrzej Januszewski Hanafi Mohammed Husin Martin I de Bock Mary B Abraham 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 BMJ Open Diabetes Research & Care |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://drc.bmj.com/content/12/6/e004428.full |
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