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Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial
Open accessAbstract
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, HbA 1c 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 1c was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2]; P P Conclusions In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA 1c , 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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“Both generation 1 low-glucose-suspend33 and generation 2 hybrid closed-loop systems improve glycated haemoglobin concentrations, the time in target range and the time below target range in children, adolescents34 and adults.35-37”
From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [35]
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Metadata
- Authors
- McAuley, S. A., Lee, M. H., Paldus, B., Vogrin, S., de Bock, M. I., Abraham, M. B., Bach, L. A., Burt, M. G., Cohen, N. D., Colman, P. G., Davis, E. A., Hendrieckx, C., Holmes-Walker, D. J., Kaye, J., Keech, A. C., Kumareswaran, K., MacIsaac, R. J., McCallum, R. W., Sims, C. M., Speight, J., Stranks, S. N., Sundararajan, V., Trawley, S., Ward, G. M., Jenkins, A. J., Jones, T. W., O’Neal, D. N., Australian JDRF Closed-Loop Research Group, O’Neal, D. N., McAuley, S. A., Lee, M. H., Paldus, B., Sims, C. M., MacIsaac, R. J., Ward, G. M., Colman, P. G., Cohen, N. D., Bach, L. A., Kumareswaran, K., Stranks, S. N., Burt, M. G., Holmes-Walker, D. J., McCallum, R. W., Kaye, J., Speight, J., Hendrieckx, C., Halliday, J., Russell-Green, S., Trawley, S., Jenkins, A. J., Januszewski, A., Keech, A. C., Vogrin, S., Sundararajan, V., Mohammed Husin, H., Clarke, P. M., Jones, T. W., Davis, E. A., de Bock, M. I., Abraham, M. B., Ambler, G. R., Cameron, F. J., Fairchild, J. M., & King, B. R.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2020-10-14
- Volume
- 43
- Issue
- 12
- Pages
- 3024-3033
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W3092965120
- Cited by
- 158
- References
- 38
- Citations by year
- 2026: 17 · 2025: 24 · 2024: 33 · 2023: 37 · 2022: 30 · 2021: 16 · 2020: 1
- FWCI
- 15.84
- Type
- journal article
- Language
- en
- Open access
- green
- figshare.com
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Deakin Research Online (Deakin University) (submittedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Funders
- JDRF Australian Type 1 Diabetes Clinical Research Network (3-SRA-2016-351-M-B)
- National Health and Medical Research Council of Australia (APP1099379)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- type 1 diabetes, hybrid closed-loop insulin delivery, insulin pump therapy, multiple daily insulin injections, continuous glucose monitoring, time in range, glycemic control, HbA1c, diabetes distress, sleep quality, cognitive function, device-related adverse events, adults with type 1 diabetes, diabetes self-management
- MeSH terms
- Adult, Aged, Blood Glucose, Blood Specimen Collection, Diabetes Mellitus, Type 1, Female, Fingers, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Injections, Insulin, Insulin Infusion Systems, Male, Middle Aged, Personal Satisfaction, Blood Glucose Self-Monitoring, Needlestick Injuries
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