Journal article
Hybrid Closed Loop in Adults With Type 1 Diabetes and Severely Impaired Hypoglycemia Awareness
MH Lee, J Gooley, V Obeyesekere, J Lu, B Paldus, C Hendrieckx, RJ MacIsaac, SA McAuley, J Speight, S Vogrin, AJ Jenkins, DJ Holmes-Walker, DN O’Neal, GM Ward
Journal of Diabetes Science and Technology | SAGE PUBLICATIONS INC | Published : 2025
Abstract
Background: Benefits of hybrid closed-loop (HCL) systems in a high-risk group with type 1 diabetes and impaired awareness of hypoglycemia (IAH) have not been well-explored. Methods: Adults with Edmonton HYPO scores ≥1047 were randomized to 26-weeks HCL (MiniMed™ 670G) vs standard therapy (multiple daily injections or insulin pump) without continuous glucose monitoring (CGM) (control). Primary outcome was percentage CGM time-in-range (TIR; 70-180 mg/dL) at 23 to 26 weeks post-randomization. Major secondary endpoints included magnitude of change in counter-regulatory hormones and autonomic symptom responses to hypoglycemia at 26-weeks post-randomization. A post hoc analysis evaluated glycemia ..
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Grants
Awarded by Australian Research Council
Funding Acknowledgements
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This trial was funded by JDRF Australian Type 1 Diabetes Clinical Research Network (3-SRA-2016-351-M-B), a special initiative of the Australian Research Council, and the National Health and Medical Research Council of Australia (APP1099379). In-kind support was provided by Medtronic (HCL systems, masked CGM devices, and technical expertise with device issues) and Roche Diabetes Care (blood glucose meters for participants using MDI). M.H.L. is supported by a National Health and Medical Research Council postgraduate scholarship, co-funded by Diabetes Australia. B.P. is supported by a University of Melbourne scholarship and research support from JDRF. C.H. and J.S. are supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. R.J.M. received research grants from the Rebecca L. Cooper Medical Research Foundation, St Vincent's Foundation, JDRF, Diabetes Australia Research Trust/Program, and the National Health and Medical Research Council of Australia. S.A.M. has been supported by a JDRF Research Award (5-ECR-2017-371-A-N) and University of Melbourne Paul Desmond Clinical Research Fellowship. A.J.J. is supported by a National Health and Medical Research Council Fellowship and is a Sydney Medical School Foundation Fellow. A.J.J. received research support from the National Health and Medical Research Council of Australia, JDRF Australia, and JDRF International. JDRF Australia provided input into the trial design. The funders of the trial had no role in data collection, data analysis, data interpretation, or writing of the report.