Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000099527
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
4/02/2015
Date last updated
8/01/2020
Date data sharing statement initially provided
22/01/2019
Date results information initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Glycaemia and cardiac rhythm disturbances in survivors of critical illness with pre-existing diabetes
Scientific title
Glycaemia and cardiac rhythm disturbances in survivors of critical illness with pre-existing diabetes
Secondary ID [1] 285832 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 293750 0
Critical Illness 293751 0
Condition category
Condition code
Metabolic and Endocrine 294049 294049 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Thirty patients with diabetes diagnosed previously or on this admission (HbA1c > 6.5%) who were admitted to ICU with at least 24 h of organ failure and require either insulin or sulponylureas following discharge from ICU and who are anticipated to remain an inpatient for at least 48 h after ICU discharge will be eligible. All patients enrolled into the study must be able to provide informed consent.

All patients will have simultaneous 12-lead Holter and continuous interstitial glucose (IG) monitoring (CGM) from enrolment until discharge or for a maximum of 5 days. There will be no change in treatment instituted, e.g. patients will carry on with their usual activities and diabetes treatments. Twelve-lead ambulatory ECGs (Lifecard 12; Spacelabs Healthcare, Hertford, U.K.) will be recorded at a sampling rate of 128 Hz with electrodes in a Mason-Likar configuration. Patients will also have a time-synchronized CGM attached (FreeStyle Navigator Continuous Glucose Monitoring System; Abbott Diabetes Care, Maidenhead, U.K.). Calibrations will ideally be performed daily (but no less frequent than 48 hourly) according to the manufacturer’s instructions. Studies will occur in ‘blinded mode’ which means that alarms do not sound and patients and health care practitioners cannot view CGM glucose values. Patients/health care practitioners will be also asked to keep a record of any symptomatic hypoglycaemia. An episode of IG < 3.5 mmol/L on CGM without simultaneous self-report of symptoms is regarded as asymptomatic.
Intervention code [1] 290811 0
Not applicable
Comparator / control treatment
Control group no longer being studied at this point.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293826 0
To determine the prevalence of asymptomatic hypoglycaemia in survivors of critical illness who have pre-existing diabetes. This primary outcome will be assessed via blood glucose monitoring.
Timepoint [1] 293826 0
1 week
Primary outcome [2] 293947 0
To determine the prevalence of cardiac arrhythmias in survivors of critical illness who have pre-existing diabetes. This primary outcome will be assessed via ECG recordings.
Timepoint [2] 293947 0
1 week
Secondary outcome [1] 311952 0
To determine whether there is an association between asymptomatic hypoglycaemia and cardiac arrhythmias in survivors of critical illness. This primary outcome will be assessed via blood glucose monitoring and ECG recordings.
Timepoint [1] 311952 0
1 week

Eligibility
Key inclusion criteria
Patients: diabetic patients admitted to the ICU with at least 24 hours of organ failure and require either insulin or sulphonyureas. Included patients must all be anticipated to remain an inpatient for at least 48 hours. All enrolled patients must provide informed consent.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative care
Permanent atrial fibrillation
Pacemaker in situ
Post-cardiac surgery (within previous 6 months)
Acute myocardial infarction (within previous 6 months)
On drugs which prolong QT interval

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Study sample size was determined based on previous similar studies. A difference will be considered statistically significant when the a risk is <5% (P<0.05).

Outcome variables, as outlined in the methods, will be analysed using an appropriate statistical method such as t-tests and mann-whitney calculations

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2015
Actual
15/03/2016
Date of last participant enrolment
Anticipated
29/03/2019
Actual
21/01/2019
Date of last data collection
Anticipated
29/03/2019
Actual
1/03/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 3259 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 12976 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 9053 0
5000 - Adelaide
Recruitment postcode(s) [2] 25455 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 290405 0
Government body
Name [1] 290405 0
NHMRC
Country [1] 290405 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Adam Deane
Address
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 289203 0
Individual
Name [1] 289203 0
Professor Michael Horowitz
Address [1] 289203 0
University of Adelaide, Royal Adelaide Hospital
North Terrace
Adelaide 5000
South Australia
Country [1] 289203 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292098 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 292098 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 292098 0
Australia
Date submitted for ethics approval [1] 292098 0
Approval date [1] 292098 0
04/12/2014
Ethics approval number [1] 292098 0
141208

Summary
Brief summary
To continuously evaluate glucose concentrations and electrocardiogram changes in patients with pre-existing diabetes who are discharged from the Intensive Care Unit (ICU), so as to evaluate whether a relationship exists between asymptomatic hypoglycaemia and cardiac arrhythmias in this cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53478 0
A/Prof Adam Deane
Address 53478 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 53478 0
Australia
Phone 53478 0
+61 8 8222 4624
Fax 53478 0
Email 53478 0
[email protected]
Contact person for public queries
Name 53479 0
A/Prof Adam Deane
Address 53479 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 53479 0
Australia
Phone 53479 0
+61 8 8222 4624
Fax 53479 0
Email 53479 0
[email protected]
Contact person for scientific queries
Name 53480 0
A/Prof Adam Deane
Address 53480 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 53480 0
Australia
Phone 53480 0
+61 8 8222 4624
Fax 53480 0
Email 53480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.