Liberal blood glucose control in critically ill patients with pre-existing type 2 diabetes.

• Register: ANZCTR
• Last refreshed on: 27 December 2021
• Main ID: ACTRN12616001135404
• Date of registration: 19/08/2016
• Prospective Registration: Yes
• Primary sponsor: Royal Adelaide Hospital
• Public title: Liberal blood glucose control in critically ill patients with pre-existing type 2 diabetes.
• Scientific title: Liberal glUcose Control in critically Ill patients with pre-existing type 2 Diabetes (LUCID): a phase II multicentre randomised controlled trial to evaluate the prevalence and effect of hypoglycaemia.
• Date of first enrolment: 08/05/2017
• Target sample size: 450
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12616001135404.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Mr Alex Poole

• Name: A/Prof Adam Deane

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients (aged 18 years or older).
Expected to remain in the ICU until the day after tomorrow.
Patient has either an arterial or central line in situ, or the placement of an arterial or central line is imminent (within the next hour) as part of routine ICU management.
Patient has type 2 diabetes.
The treating clinician believes that that there is a reasonable likelihood that a blood glucose concentration greater than or equal to 10 mmol/L will be recorded at some stage during the ICU admission.

Exclusion criteria: Death during ICU admission is deemed to be inevitable.
Admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
Patients who have juvenile type 1 diabetes.
Requirement for specific blood glucose target as determined by the treating doctor, i.e. the treating clinician believes either intervention or standard care arms of LUCID would not be in the best interests of the patient
Patients expected to be eating before the end of the next calendar day.
Patients who have previously suffered hypoglycemia without documented full neurological recovery.
Patient cannot provide prior informed consent and there is documented evidence that the patient has no legal surrogate decision maker, and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
Patient has been in the study ICU or another ICU for greater than or equal to 24 h during the index admission.
Patient has previously been enrolled in LUCID.
Females who are pregnant or suspected to be pregnant determined by a positive serum or urine human chorionic gonadotropin (hCG) test.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Type 2 Diabetes;Critical illness;
Type 2 Diabetes
Critical illness

Intervention(s)

The intervention will be delivered by an ICU nurse, the insulin will be commenced when blood glucose > 14.0 mmol/L and infusion adjusted to target blood glucose 10-14 mmo/L. Concentrations < 10 mmol/L would not be actively treated with glucose. As per the NICE-SUGAR trial each ICU will be able to use the relevant institutional protocol rather than a standardised protocol.
Treatment will be for the duration of ICU admission until day 28.
Study data will be collected by the sites research nurse and each site will have a monitoring visit to ensure accurate data collection.

Primary Outcome(s)

Incident hypoglycaemia (defined as a blood glucose reading < 4.0 mmol/L) during ICU admission.[During ICU admission up to and including day 28.]

Secondary Outcome(s)

Results ofEQ-5DL quality of life survey [performed at day 90]

We will report patients measurement of HbA1c (2ml). HbA1c will be measured using high performance liquid chromatography at each site. [On recruitment in to the study.]

We will report severity of hypoglycaemia from clinically recorded point of care testing.
[During ICU admission up to and including day 28.]

We will report drop from peak glucose > 30%. Premorbid estimated average glucose will be calculated by the formula estimated average glucose (mmol/L) = 1.59 X HbA1c (%) - 2.59) [During ICU admission up to and including day 28]

We will report time-weighted mean glucose.
The precise frequency of blood glucose measurement will be determined by local practice but be no less than every four hours and we will record whether measurement is via blood gas analyser or point of care glucometry.[During ICU admission up to and including day 28.]

90 day all-cause mortality[at 90 days]

We will report frequency of hypoglycaemia (defined as a new blood glucose < 4.0 mmol/L recorded without a blood glucose < 4.0 mmol/L recorded in the previous 4 hours) from clinically recorded point of care testing.[During ICU admission up to and including day 28]

We will report glycaemic variability (both coefficient of variability and standard deviation for each patient). The precise frequency of blood glucose measurement will be determined by local practice but be no less than every four hours and we will record whether measurement is via blood gas analyser or point of care glucometry.[During ICU admission up to and including day 28.]

We will report relative hypoglycaemia (defined as > 30% drop from premorbid estimated average glucose, which will be calculated by the formula estimated average glucose (mmol/L) = 1.59 X HbA1c (%) - 2.59) [During ICU admission up to and including day 28.]

ICU and hospital discharge status[at day 90]

Number of days alive and not in hospital censored at 90 days[at 90 days]

Percentage of patients with positive blood cultures to day 28 [at day 28]

Source(s) of Monetary Support

Diabetes Australia

Royal Adelaide Hospital

Intensive Care Foundation

Ethics review

Status: Approved
Approval date: 07/03/2016
Contact:

Central Australian Human Research Ethics Committee

Status: Approved
Approval date: 27/03/2017
Contact:

Royal Adelaide Hospital

Status: Approved
Approval date: 08/11/2017
Contact:

the Alfred Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 21/12/2021
• Date Completed: 31/12/2020