Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000555358
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
20/04/2017
Date last updated
27/03/2019
Date data sharing statement initially provided
27/03/2019
Date results information initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Relationship between glycated haemoglobin (HbA1c) point-of-care and laboratory testing in intensive care unit (ICU) patients with diabetes
Scientific title
Relationship between glycated haemoglobin (HbA1c) point-of-care and laboratory testing in ICU patients with diabetes
Secondary ID [1] 291674 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 302831 0
Type 1 Diabetes 302832 0
Type 2 Diabetes 302833 0
Hypoglycemia 302834 0
Critically Ill 302836 0
Condition category
Condition code
Metabolic and Endocrine 302325 302325 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a study evaluating the agreement between point-of-care HbA1c analysis when compared to laboratory analysis. ICU patients with known diabetes will have a capillary and arterial blood sample tested on a point -of-care HbA1c analyzer (Siemens DCA Vantage Analyzer). The same arterial sample will be sent to a central labratory for HbA1c analysis. In the case where an arterial sample is not available, a venous sample will be used.
Intervention code [1] 297761 0
Not applicable
Comparator / control treatment
Two tests of HbA1c analysis will be compared to determine agreement. Therefore, the control is the standard of care, which is the use of an arterial sample for laboratory analysis of HbA1c in ICU.
Control group
Active

Outcomes
Primary outcome [1] 301737 0
To determine the agreement between point-of-care and laboratory HbA1c testing in critically ill patients with diabetes. Agreement between measures will be analysed by Lin’s concordance correlation coefficient with Bland-Altman plots including 95% confidence limits of agreement. References 1 and 2.

1. Lin, L. I-K. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45: 255-268.
2. Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet I: 307-310.
Timepoint [1] 301737 0
The timepoint of the primary outcome is the time at which a capillary and arterial sample is taken for HbA1c analysis.
Secondary outcome [1] 333702 0
To record the errors that occur when measuring samples on the HbA1c analyzer.
Timepoint [1] 333702 0
At time of HbA1c analysis following patient admission to ICU.
Secondary outcome [2] 333703 0
Subgroup analysis of statistical agreement between the point-of-care analyzer and patients with HbA1c less than 7%.
Timepoint [2] 333703 0
Agreement between measures will be analysed by Lin’s concordance correlation coefficient with Bland-Altman plots including 95% confidence limits of agreement. References 1 and 2. This is in order to determine if the tests agree better at lower HbA1c levels.

1. Lin, L. I-K. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45: 255-268.
2. Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet I: 307-310.
Secondary outcome [3] 333951 0
Subgroup analysis of statistical agreement between the point-of-care analyzer and patients with HbA1c greater than or equal to 7%.
Timepoint [3] 333951 0
Agreement between measures will be analysed by Lin’s concordance correlation coefficient with Bland-Altman plots including 95% confidence limits of agreement. References 1 and 2. This is in order to determine if the tests agree better at lower HbA1c levels.

1. Lin, L. I-K. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45: 255-268.
2. Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet I: 307-310.

Eligibility
Key inclusion criteria
Participants will include all patients with known diabetes admitted to the Intensive Care Unit (ICU).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria aside from opposite of inclusion criteria.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/04/2017
Actual
16/06/2017
Date of last participant enrolment
Anticipated
1/06/2017
Actual
31/07/2017
Date of last data collection
Anticipated
1/06/2017
Actual
31/07/2017
Sample size
Target
50
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296173 0
Hospital
Name [1] 296173 0
Royal Adelaide Hospital ICU Research Department
Country [1] 296173 0
Australia
Primary sponsor type
Individual
Name
Dr Palash Kar
Address
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country
Australia
Secondary sponsor category [1] 295079 0
None
Name [1] 295079 0
Address [1] 295079 0
Country [1] 295079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297417 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 297417 0
Level 4, Women's Health Centre,
Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 297417 0
Australia
Date submitted for ethics approval [1] 297417 0
06/04/2017
Approval date [1] 297417 0
07/04/2017
Ethics approval number [1] 297417 0

Summary
Brief summary
Point-of-care HbA1c testing in the intensive care setting may be advantageous for patients with diabetes who are admitted to ICU because including rapid availability of the result may guide insulin therapy. This may be of particular benefit for patients with poor glycemic control that are at a greater risk of hypoglycemic complications. However the accuracy of the HbA1c point of care testing has not been validated in the critically ill.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73978 0
Dr Palash Kar
Address 73978 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country 73978 0
Australia
Phone 73978 0
+61 8 8222 4624
Fax 73978 0
Email 73978 0
p_kar@hotmail.com
Contact person for public queries
Name 73979 0
Dr Yasmine Ali Abdelhamid
Address 73979 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country 73979 0
Australia
Phone 73979 0
+61 8 8222 4624
Fax 73979 0
Email 73979 0
yasmine.aliabdelhamid@sa.gov.au
Contact person for scientific queries
Name 73980 0
Dr Yasmine Ali Abdelhamid
Address 73980 0
ICU Research Department,
Level 4 North Wing, Royal Adelaide Hospital,
North Terrace, Adelaide, SA 5000
Australia
Country 73980 0
Australia
Phone 73980 0
+61 8 8222 4624
Fax 73980 0
Email 73980 0
yasmine.aliabdelhamid@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in original HREC submission


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Aust Crit Care. 2018 Dec 24. pii: S1036-7314(18)30... [More Details]

Documents added automatically
No additional documents have been identified.