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
Authors
Tripyla, Afroditi
Hartnell, Sara
Daly, Aideen
Herzig, David
Wilinska, Malgorzata E.
Fry, Andrew
Publication Date
2021-08-04Journal Title
Nature Medicine
ISSN
1078-8956
Publisher
Nature Publishing Group US
Volume
27
Issue
8
Pages
1471-1476
Language
en
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
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
Description
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
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.
Keywords
Article, /692/163/2743/137/773, /692/699/1585/104/1586, article
Identifiers
s41591-021-01453-z, 1453
External DOI: https://doi.org/10.1038/s41591-021-01453-z
This record's URL: https://www.repository.cam.ac.uk/handle/1810/329514
Rights
Licence:
http://creativecommons.org/licenses/by/4.0/
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