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Trial registered on ANZCTR


Registration number
ACTRN12612001274864
Ethics application status
Approved
Date submitted
3/12/2012
Date registered
10/12/2012
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Date results provided
1/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Defining optimal glucose targets in critically ill patients with pre-existing type 2 diabetes and chronic hyperglycaemia.
Scientific title
Evaluation of acute glycaemia on biomarkers and clinical outcomes in critically ill patients with pre-existing type 2 diabetes and chronic hyperglycaemia.
Secondary ID [1] 281575 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients type 2 diabetes and chronic hyperglycaemia 287857 0
Condition category
Condition code
Metabolic and Endocrine 288216 288216 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a change in insulin protocol in the Intensive Care Unit (ICU) patients with chronic hyperglycaemia or poorly controlled pre-existing type 2 diabetes. Patients will be identified by a Hba1c test (glycated haemoglobin) on admission to ICU. Patients with a HbA1c >6.9% (or 51 mmol/mol) will be treated with a new Insulin protocol.
This study will be performed sequentially; initially (6 months) the study will observe the current Insulin regimen, followed by a 2nd 6 month period in which the intervention (an altered Insulin regimen) will be implemented. The 2 study periods will be separated by 1 month to prevent patients from the control period being included in the intervention period.
The new protocol targets blood glucose levels of 10-14 mmol/L in chronic hyperglycaemic patients and poorly controlled type 2 diabetic patients. The current insulin protocol targets blood glucose levels of 6-10 mmol/L. This will involve a change in practice for the bedside nurse who will administer insulin as required to reach the target blood glucose level. The new protocol will result in the administration of less insulin than the current protocol.
All patients (including diabetic patients) with a HbA1c of 6.9% or below will continue with the control Insulin regimen if required.
Intervention code [1] 286099 0
Treatment: Drugs
Comparator / control treatment
Standard Care; the current Insulin regimen, targeting blood glucose levels 6-10mmol/l, will be performed when required in all patients.
6 month period of chronic hyperglycaemic and poorly controlled diabetic patients treated with the current Insulin regimen, targeting blood glucose level of 6-10 mmol/L. These patients will only receive standard care.
This 6 month period will be followed by a 1 month 'washout' period to ensure that these patients do not receive both the control and intervention Insulin regimens.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288410 0
All-cause mortality (ICU, hospital and 90 day) will be assessed from medical records.
Timepoint [1] 288410 0
Within 90 days of current ICU admission.
Secondary outcome [1] 300080 0
Markers of cardiovascular stress (endogenous catecholamine secretion, electrocardiogram (ECG) changes (QT interval), number of cardiac deaths) will be assessed from blood samples and medical records.
Timepoint [1] 300080 0
During ICU stay or 7 days from admission.
Secondary outcome [2] 300081 0
Markers of oxidative stress (plasma IL-6, F2-isoprostane, myeloperoxidase (MPO), low molecular weight (LMW)-fluorophores and N-Carboxymethyl-lysine (CML) concentrations). These biomarkers will be measured from blood and urine samples taken from each patient.
Timepoint [2] 300081 0
During ICU stay or 7 days from admission.
3 month post ICU follow up blood sample.
Secondary outcome [3] 300082 0
Morbidity (days of ventilation, renal failure requiring renal support, delirium, critical illness weakness) will be assessed from medical records
Timepoint [3] 300082 0
During ICU admission.
Secondary outcome [4] 300083 0
Mean blood glucose concentrations will be recorded from the ICU nursing charts in each patients medical records.
Timepoint [4] 300083 0
During ICU stay or 7 days from admission.
Secondary outcome [5] 300084 0
Number of hypoglycaemic events (defined as 'mild' > 4.0 blood glucose < 6 mmol/l, 'moderate' > 2.3 blood glucose < 4 mmol/l and 'severe' < 2.2 mmol/l) will be recorded from the ICU nursing charts in each patients medical records.
Timepoint [5] 300084 0
During ICU stay or 7 days from admission.
Secondary outcome [6] 300085 0
Plasma 1,5 anhydroglucitol concentrations will be assessed from blood samples.
Timepoint [6] 300085 0
During ICU stay or 7 days from admission.
3 month post ICU follow up blood sample.
Secondary outcome [7] 300086 0
Glycaemic variability will be assessed from the ICU nursing charts in each patients medical records.
Timepoint [7] 300086 0
During ICU stay or 7 days from admission.
Secondary outcome [8] 300087 0
Time period that blood glucose concentrations are outside target range will be recorded from the ICU nursing charts in each patients medical records.
Timepoint [8] 300087 0
During ICU stay or 7 days from admission.
Secondary outcome [9] 300088 0
Amount of insulin administered to patients will be recorded from the ICU nursing charts in each patients medical records.
Timepoint [9] 300088 0
During ICU stay or 7 days from admission.
Secondary outcome [10] 300089 0
Amount of calories delivered to patients (and episodes of feed intolerance defined as a single gastric residual volume > 250ml) will be recorded from the ICU nursing charts in each patients medical records.
Timepoint [10] 300089 0
During ICU stay or 7 days from admission.

Eligibility
Key inclusion criteria
New admission to ICU
HbA1c greater than 6.9% or 51 mmol/mol
Anticipated to remain in ICU for 48 hours or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HbA1c less than 6.9%
Type-1 diabetes.
Expected to die within 48 hours
Not expected to stay for at least 48 hours
Readmission to ICU

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with a HbA1c greater than 6.9% will be enrolled in the study.
For 6 months all patients will be treated with standard care.
There will be a 1 month 'washout' period to ensure patients from the control 6 month period are not included in the 6 month intervention period.
For the 2nd 6 month period all patients will be treated with the altered Insulin regimen.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential.
The control and intervention arms of the study will occur in different patients over 2 separate 6 month periods.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2012
Actual
19/08/2012
Date of last participant enrolment
Anticipated
22/08/2013
Actual
5/10/2013
Date of last data collection
Anticipated
Actual
30/11/2013
Sample size
Target
400
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment postcode(s) [1] 6054 0
5000
Recruitment postcode(s) [2] 6055 0
3084

Funding & Sponsors
Funding source category [1] 286371 0
Charities/Societies/Foundations
Name [1] 286371 0
Diabetes Australia Research Trust
Country [1] 286371 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Deane
Address
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285212 0
Individual
Name [1] 285212 0
Dr Mark Plummer
Address [1] 285212 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [1] 285212 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288445 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 288445 0
Ethics committee country [1] 288445 0
Australia
Date submitted for ethics approval [1] 288445 0
Approval date [1] 288445 0
08/08/2012
Ethics approval number [1] 288445 0
120712

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34974 0
Dr Adam Deane
Address 34974 0
Intensive Care Unit
Level 4, Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 34974 0
Australia
Phone 34974 0
+610882222818
Fax 34974 0
Email 34974 0
adam.deane@adelaide.edu.au
Contact person for public queries
Name 18221 0
Adam Deane
Address 18221 0
Intensive Care Unit
Level 4, Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 18221 0
Australia
Phone 18221 0
+610882222818
Fax 18221 0
Email 18221 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 9149 0
Adam Deane
Address 9149 0
Intensive Care Unit
Level 4, Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 9149 0
Australia
Phone 9149 0
+610882222818
Fax 9149 0
Email 9149 0
adam.deane@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.