Poole, Alexis P

Finnis, Mark E

Anstey, James

Bellomo, Rinaldo

Bihari, Shailesh

Biradar, Vishwanath

Doherty, Sarah

Eastwood, Glenn

Finfer, Simon

French, Craig J

Ghosh, Angaj

Heller, Simon

Horowitz, Michael

Kar, Palash

Kruger, Peter S

Maiden, Matthew J

Mårtensson, Johan

McArthur, Colin J

McGuinness, Shay P

Secombe, Paul J

Tobin, Antony E

Udy, Andrew A

Young, Paul J

Deane, Adam M

2020-06

BACKGROUND: Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes. OBJECTIVE: To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L). MAIN OUTCOME MEASURES: The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. RESULTS AND CONCLUSION: The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised. TRIAL REGISTRATION: This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.

Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia. Alexis.Poole@adelaide.edu.au.

Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.

Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.

Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.

Department of Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, SA, Australia.

Department of Intensive Care, Lyell McEwin Hospital, Adelaide, SA, Australia.

The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.

Department of Intensive Care, Western Health, Melbourne, VIC, Australia.

Intensive Care Unit, Northern Health, Melbourne, VIC, Australia.

Clinical Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, United Kingdom.

Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.

Department of Intensive Care, Princess Alexandra Hospital, Brisbane, QLD, Australia.

Section of Anaesthesia and Intensive Care Medicine, Department of Physiology and Pharmacology, Karolinska Institutet, Solna, Sweden.

Department of Critical Care Medicine, Auckland District Health Board, Auckland, New Zealand.

Cardiothoracic and Vascular Intensive Care and High Dependency Unit, Auckland District Health Board, Auckland, New Zealand.

Department of Intensive Care, Alice Springs Hospital, Alice Springs, NT, Australia.

Department of Intensive Care, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.

Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia.

Medical Research Institute of New Zealand, Wellington, New Zealand.

Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia. Adam.Deane@mh.org.au.

Crit Care Resusc. 2020 Jun;22(2):133-141.

https://pubmed.ncbi.nlm.nih.gov/32389105/?otool=iaurydwlib

https://hdl.handle.net/10137/8408

22

Australia

Blood Glucose/*metabolism

Chronic Disease

*Clinical Trial Protocols as Topic

*Critical Care

Critical Illness

Diabetes Mellitus, Type 2/blood/*complications

Humans

New Zealand

*Randomized Controlled Trials as Topic

Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.

Journal Article

Randomized Controlled Trial

Publication