Randomized Controlled Trial

. 2024 Dec 22;12(6):e004428.

doi: 10.1136/bmjdrc-2024-004428.

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

Jennifer A Halliday^{1

2

3}, Sienna Russell-Green^{2

3}, Benjamin Lam^{2

3

4}, Steven Trawley^{2

3

5

6}, Sybil A McAuley^{5

6

7

8

9}, Leon A Bach^{9

10}, Morton G Burt^{11

12}, Neale D Cohen^{8

13

14}, Peter G Colman^{6

15}, Elizabeth A Davis^{16

17

18}, Deborah Jane Holmes-Walker^{19

20}, Alicia J Jenkins^{6

7

21}, Joey Kaye²², Anthony C Keech²¹, Melissa H Lee^{6

7}, Roland W McCallum²³, Barbora Paldus^{6

7}, Stephen N Stranks^{11

12}, Vijaya Sundararajan²⁴, Glenn Ward^{6

7}, Timothy W Jones^{16

17

18}, David O'Neal^{6

7}, Jane Speight^{25

2

3}, Christel Hendrieckx^{2

3}; Australian JDRF Closed-Loop Research Group Members

Collaborators, Affiliations

Collaborators

Australian JDRF Closed-Loop Research Group Members:
David N O'Neal, Sybil A McAuley, Melissa H Lee, Barbora Paldus, Catriona M Sims, Richard J MacIsaac, Glenn M Ward, Peter G Colman, Neale D Cohen, Leon A Bach, Kavita Kumareswaran, Stephen N Stranks, Morton G Burt, D Jane Holmes-Walker, Roland W McCallum, Joey Kaye, Jane Speight, Christel Hendrieckx, Jennifer A Halliday, Sienna Russell-Green, Steven Trawley, Alicia J Jenkins, Andrzej Januszewski, Anthony C Keech, Sara Vogrin, Vijaya Sundararajan, Hanafi Mohammed Husin, Philip M Clarke, Timothy W Jones, Elizabeth A Davis, Martin I de Bock, Mary B Abraham, Geoff R Ambler, Fergus J Cameron, Jan M Fairchild, Bruce R King

Affiliations

¹ Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia j.halliday@deakin.edu.au.
² The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, Australia.
³ School of Psychology, Deakin University, Geelong, Victoria, Australia.
⁴ Education Futures, University of South Australia, Adelaide, South Australia, Australia.
⁵ The Cairnmillar Institute, Melbourne, Victoria, Australia.
⁶ Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
⁷ Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
⁸ School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
⁹ Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia.
¹⁰ School of Translational Medicine, Monash University, Melbourne, Victoria, Australia.
¹¹ Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.
¹² College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
¹³ Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.
¹⁴ School of Pharmacy, University of Queensland, St Lucia, Queensland, Australia.
¹⁵ Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.
¹⁶ Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Western Australia, Australia.
¹⁷ School of Paediatrics and Child Health, The University of Western Australia, Perth, Tasmania, Australia.
¹⁸ Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
¹⁹ Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
²⁰ Department of Diabetes and Endocrinology, Westmead Hospital, Sydney, New South Wales, Australia.
²¹ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
²² Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
²³ Department of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia.
²⁴ Department of Public Health, La Trobe University, Melbourne, Victoria, Australia.
²⁵ Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.

PMID: 39797667
PMCID: PMC11683942
DOI: 10.1136/bmjdrc-2024-004428

Randomized Controlled Trial

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

Jennifer A Halliday et al. BMJ Open Diabetes Res Care. 2024.

. 2024 Dec 22;12(6):e004428.

doi: 10.1136/bmjdrc-2024-004428.

Authors

Collaborators

Australian JDRF Closed-Loop Research Group Members:
David N O'Neal, Sybil A McAuley, Melissa H Lee, Barbora Paldus, Catriona M Sims, Richard J MacIsaac, Glenn M Ward, Peter G Colman, Neale D Cohen, Leon A Bach, Kavita Kumareswaran, Stephen N Stranks, Morton G Burt, D Jane Holmes-Walker, Roland W McCallum, Joey Kaye, Jane Speight, Christel Hendrieckx, Jennifer A Halliday, Sienna Russell-Green, Steven Trawley, Alicia J Jenkins, Andrzej Januszewski, Anthony C Keech, Sara Vogrin, Vijaya Sundararajan, Hanafi Mohammed Husin, Philip M Clarke, Timothy W Jones, Elizabeth A Davis, Martin I de Bock, Mary B Abraham, Geoff R Ambler, Fergus J Cameron, Jan M Fairchild, Bruce R King

Affiliations

¹ Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia j.halliday@deakin.edu.au.
² The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, Victoria, Australia.
³ School of Psychology, Deakin University, Geelong, Victoria, Australia.
⁴ Education Futures, University of South Australia, Adelaide, South Australia, Australia.
⁵ The Cairnmillar Institute, Melbourne, Victoria, Australia.
⁶ Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
⁷ Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
⁸ School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
⁹ Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia.
¹⁰ School of Translational Medicine, Monash University, Melbourne, Victoria, Australia.
¹¹ Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.
¹² College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
¹³ Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.
¹⁴ School of Pharmacy, University of Queensland, St Lucia, Queensland, Australia.
¹⁵ Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.
¹⁶ Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Western Australia, Australia.
¹⁷ School of Paediatrics and Child Health, The University of Western Australia, Perth, Tasmania, Australia.
¹⁸ Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
¹⁹ Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
²⁰ Department of Diabetes and Endocrinology, Westmead Hospital, Sydney, New South Wales, Australia.
²¹ NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
²² Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
²³ Department of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia.
²⁴ Department of Public Health, La Trobe University, Melbourne, Victoria, Australia.
²⁵ Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.

PMID: 39797667
PMCID: PMC11683942
DOI: 10.1136/bmjdrc-2024-004428

Abstract

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.

Keywords: Artificial Pancreas; Diabetes Mellitus, Type 1; Patient Reported Outcome Measures.

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Conflict of interest statement

Competing interests: JAH reports speaker honoraria from Roche Diabetes Care. SAM reports support for research from Medtronic, speaker honoraria from Eli Lilly, Roche and Sanofi, and serving on advisory boards for Medtronic and Ypsomed. ST reports non-financial support from Abbott Diabetes Care. BP reports speaker honoraria fees from Medtronic. LAB reports grant funding from AstraZeneca. NDC reports personal fees from Medtronic and Abbott Laboratories and grant funds from Ypsomed Group. 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. JK reports speaker fees from Novo Nordisk and AstraZeneca and advisory board fees from Abbott Diabetes Care. MHL reports speaker honoraria from Medtronic. BP reports speaker honoraria fees from Medtronic. DO has served on advisory boards for Abbott Laboratories, Medtronic, Merck Sharp & Dohme, Novo Nordisk, Roche, and Sanofi; received research support from Medtronic, Novo Nordisk, Roche, Eli Lilly and Company, and Sanofi; and received travel support from Novo Nordisk and Merck Sharp & Dohme. JS has served on advisory boards for Insulet, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; her research group (The Australian Centre for Behavioural Research in Diabetes) has received honoraria for this advisory board participation and has also received unrestricted educational grants and/or in-kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; has received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care, and Sanofi Diabetes; and has received consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi Diabetes. The remaining authors do not report any potential conflicts of interest.

Figures

Figure 1. Study overview. CGM, continuous glucose monitor; CSII, continuous subcutaneous insulin infusion; HbA1c, glycated hemoglobin; HCL, hybrid closed-loop; MDI, multiple daily insulin injections; SMS, short messaging service.

**Figure 2. Study flow diagram. CGM, continuous glucose monitor; HCL, hybrid closed-loop.**

See this image and copyright information in PMC

References

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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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

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Full Text Sources

Medical