The effect of a liberal approach to glucose control in critically ill patients with type 2 diabetes: a multicenter, parallel-group, open-label randomized clinical trial

Abstract

Rationale: Blood glucose concentrations affect outcomes in critically ill patients, but the optimal target blood glucose range in those with type 2 diabetes is unknown.

Objectives: To evaluate the effects of a “liberal” approach to targeted blood glucose range during ICU admission.

Methods: This mutlicenter, parallel-group, open-label randomized clinical trial included 419 adult patients with type 2 diabetes expected to be in the ICU on at least three consecutive days. In the intervention group intravenous insulin was commenced at a blood glucose >252 mg/dl and titrated to a target range of 180–252 mg/dl. In the comparator group insulin was commenced at a blood glucose >180 mg/dl and titrated to a target range of 108–180 mg/dl. The primary outcome was incident hypoglycemia (<72 mg/dl). Secondary outcomes included glucose metrics and clinical outcomes.

Measurements and Main Results: By Day 28, at least one episode of hypoglycemia occurred in 10 of 210 (5%) patients assigned the intervention and 38 of 209 (18%) patients assigned the comparator (incident rate ratio, 0.21 [95% confidence interval (CI), 0.09 to 0.49]; P < 0.001). Those assigned the intervention had greater blood glucose concentrations (daily mean, minimum, maximum), less glucose variability, and less relative hypoglycemia (P < 0.001 for all comparisons). By Day 90, 62 of 210 (29.5%) in the intervention and 52 of 209 (24.9%) in the comparator group had died (absolute difference, 4.6 percentage points [95% CI, −3.9% to 13.2%]; P = 0.29).

Conclusions: A liberal approach to blood glucose targets reduced incident hypoglycemia but did not improve patient-centered outcomes.

Clinical trial registered with Australian New Zealand Clinical Trials Registry (ACTRN 12616001135404).

Metadata

Item Type:	Article
Authors/Creators:	Poole, A.P. Finnis, M.E. Anstey, J. Bellomo, R. Bihari, S. https://orcid.org/0000-0001-7553-8620 Biradar, V. Doherty, S. Eastwood, G. Finfer, S. French, C.J. Heller, S. https://orcid.org/0000-0002-2425-9565 Horowitz, M. Kar, P. Kruger, P.S. Maiden, M.J. https://orcid.org/0000-0003-4345-3213 Mårtensson, J. McArthur, C.J. McGuinness, S.P. Secombe, P.J. Tobin, A.E. Udy, A.A. Young, P.J. https://orcid.org/0000-0002-3428-3083 Deane, A.M. https://orcid.org/0000-0002-7620-5577 Schultz, R. Secombe, P. Butler, M. Cowdrey, K.-A. Gilder, E. McGuinness, S. O’Connor, K. Parke, R. Ryan, S. Woolett, M. Chen, Y. McArthur, C. McConnochie, R. Newby, L. Simmonds, C. Bellomo, R. Eastwood, G. Peck, L. Young, H. Bihari, S. Comerford, S. Jin, X. Bates, S. French, C. Marshall, F. McEldrew, R. Morgan, R. Tippett, A. Towns, M. Morrison, L. Sutton, J. White, H. Biradar, V. Soar, N. Harward, M. Kruger, P. Mackay, J. Meyer, J. Saylor, E. Wetzig, K. Brown, N. Finnis, M. Glasby, K. O’Connor, S. Poole, A. Rivett, J. Anstey, J. Barge, D. Byrne, K. Clancy, A. Deane, A. Driscoll, A. Barbazza, L. Holmes, J. Smith, R. Tobin, A. Bates, S. French, C. Marshall, F. McEldrew, R. Morgan, R. Tippett, A. Towns, M. Board, J. Martin, E. McCracken, P. Udy, A. Vallance, S. Young, M. Bone, A. Horton, M. Maiden, M. Salerno, T. Trickey, J. Latimer-Bell, C. Delaney, K. Hendry, D. Lawrence, C. Lesona, E. Milington, A. Navarra, L. Olatunji, S. Cruz, R.S. Cruz, R.S. Young, C. Young, P.
Copyright, Publisher and Additional Information:	Originally Published in: Alexis P. Poole, Mark E. Finnis, James Anstey, Rinaldo Bellomo, Shailesh Bihari, Vishwanath Biradar, Sarah Doherty, Glenn Eastwood, Simon Finfer, Craig J. French, Simon Heller, Michael Horowitz, Palash Kar, Peter S. Kruger, Matthew J. Maiden, Johan Mårtensson, Colin J. McArthur, Shay P. McGuinness, Paul J. Secombe, Antony E. Tobin, Andrew A. Udy, Paul J. Young, and Adam M. Deane. The Effect of a Liberal Approach to Glucose Control in Critically Ill Patients with Type 2 Diabetes: A Multicenter, Parallel-Group, Open-Label Randomized Clinical Trial. American Journal of Respiratory and Critical Care Medicine 2022;206:p 874-882. DOI: 10.1164/rccm.202202-0329OC Copyright © 2022 by the American Thoracic Society The final publication is available at https://www.atsjournals.org/doi/10.1164/rccm.202202-0329OC.
Keywords:	blood glucose; critical illness; diabetes; hypoglycemia; intensive care
Dates:	Published: 1 October 2022 Published (online): 24 May 2022 Accepted: 20 May 2022
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Division of Genomic Medicine (Sheffield) > Department of Oncology and Metabolism (Sheffield)
Depositing User:	Symplectic Sheffield
Date Deposited:	24 Jan 2023 11:02
Last Modified:	24 May 2023 00:13
Published Version:	http://dx.doi.org/10.1164/rccm.202202-0329oc
Status:	Published
Publisher:	American Thoracic Society
Refereed:	Yes
Identification Number:	10.1164/rccm.202202-0329oc
Related URLs:	PubMed URL
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:195517

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The effect of a liberal approach to glucose control in critically ill patients with type 2 diabetes: a multicenter, parallel-group, open-label randomized clinical trial

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