Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial
Wilinska, Malgorzata E.
Nature Publishing Group US
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Boughton, C. K., Tripyla, A., Hartnell, S., Daly, A., Herzig, D., Wilinska, M. E., Czerlau, C., et al. (2021). Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nature Medicine, 27 (8), 1471-1476. https://doi.org/10.1038/s41591-021-01453-z
Funder: CB was supported by a grant from The Novo Nordisk UK Research Foundation
Funder: LB was supported by a grant of the Swiss Society for Endocrinology and a grant of the Diabetes and Swiss Kidney Foundation.
Funder: Supported by National Institute for Health Research Cambridge Biomedical Research Centre.
Abstract: We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart (‘closed-loop’) with standard insulin therapy and a masked continuous glucose monitor (‘control’) in random order. The primary endpoint was time in target glucose range (5.6–10.0 mmol l−1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0 mmol l−1; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0–22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l−1; P = 0.003). Time in hypoglycemia (<3.9 mmol l−1) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0–0.4%) versus 0.2 (0.0–0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775.
Article, /692/163/2743/137/773, /692/699/1585/104/1586, article
External DOI: https://doi.org/10.1038/s41591-021-01453-z
This record's URL: https://www.repository.cam.ac.uk/handle/1810/329514