Sybil A McAuley1,2, Melissa H Lee1,2, Barbora Paldus1,2, Sara Vogrin1, Martin I de Bock3,4,5,6, Mary B Abraham3,4,5, Leon A Bach7,8, Morton G Burt9,10, Neale D Cohen11, Peter G Colman12, Elizabeth A Davis3,4,5, Christel Hendrieckx13,14, D Jane Holmes-Walker15,16, Joey Kaye17, Anthony C Keech18, Kavita Kumareswaran7,11, Richard J MacIsaac1,2, Roland W McCallum19, Catriona M Sims1, Jane Speight13,14, Stephen N Stranks9,10, Vijaya Sundararajan20, Steven Trawley1,14,21, Glenn M Ward1,2, Alicia J Jenkins1,2,17, Timothy W Jones3,4,5, David N O'Neal. 1. Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia. 2. Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia. 3. Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia. 4. Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia. 5. School of Paediatrics and Child Health, University of Western Australia, Nedlands, Western Australia, Australia. 6. Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand. 7. Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia. 8. Department of Medicine (Alfred Medical Research and Education Precinct), Monash University, Melbourne, Victoria, Australia. 9. Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia. 10. College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia. 11. Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia. 12. Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia. 13. School of Psychology, Deakin University, Geelong, Victoria, Australia. 14. Australian Centre for Behavioural Research in Diabetes, North Melbourne, Victoria, Australia. 15. Department of Diabetes and Endocrinology, Westmead Hospital, Westmead, New South Wales, Australia. 16. Sydney Medical School, University of Sydney, Camperdown, New South Wales, Australia. 17. Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia. 18. NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia. 19. Department of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia. 20. Department of Public Health, La Trobe University, Melbourne, Victoria, Australia. 21. The Cairnmillar Institute, Hawthorn East, Victoria, Australia.
Abstract
OBJECTIVE: To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes). RESEARCH DESIGN AND METHODS: Adults with type 1 diabetes usingMDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks. RESULTS: Participants were randomized to HCL (n = 61) or control (n = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA1c was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19]; P < 0.0001). For HCL, HbA1c was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2]; P < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9]; P < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively. CONCLUSIONS: In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.
RCT Entities:
OBJECTIVE: To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes). RESEARCH DESIGN AND METHODS: Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks. RESULTS:Participants were randomized to HCL (n = 61) or control (n = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA1c was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19]; P < 0.0001). For HCL, HbA1c was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2]; P < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9]; P < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively. CONCLUSIONS: In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.
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