Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000004561
Ethics application status
Approved
Date submitted
14/12/2014
Date registered
7/01/2015
Date last updated
8/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring glucose and lactate in healthy volunteers and patients with diabetes: Do new blood collection tubes produce more accurate laboratory values?
Scientific title
When measuring laboratory plasma glucose in healthy and diabetic participants, are citrate/fluoride blood collection tubes superior to fluoride tubes with regards to minimising pre-analytical loss of glucose?
Secondary ID [1] 285847 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 293761 0
Condition category
Condition code
Metabolic and Endocrine 294060 294060 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Collection of 40ml venous blood from the antecubital fossa of participants, on two separate occasions up to one week apart. Pre-analytical loss of glucose will be determined on both occasions, using three different blood collection tube systems. (One is the 'new' citrate/fluoride collection tube, the other two collection tubes are in common everyday use, that is they are used in routine clinical care).
Intervention code [1] 290823 0
Diagnosis / Prognosis
Intervention code [2] 290824 0
Early detection / Screening
Comparator / control treatment
Laboratory plasma glucose measured using the 'new' citrate/fluoride tubes will be compared at times 0 hours, 2 hours and 24 hours with a) fluoride 'grey top' tubes and b) lithium heparin PST tubes
Control group
Active

Outcomes
Primary outcome [1] 293840 0
Glucose loss using the citrate/fluoride collection system, compared to glucose loss using the fluoride system.
Timepoint [1] 293840 0
Separation of plasma from red cells 2 hours after each of the two venesections
Secondary outcome [1] 311969 0
Comparison of intra-individual pre-analytical glucose loss using fluoride blood collection tubes.
Timepoint [1] 311969 0
2 hours after each of the two venesections.
Secondary outcome [2] 311970 0
Comparison of intra-individual pre-analytical glucose loss using fluoride blood collection tubes.
Timepoint [2] 311970 0
24 hours after each of the two venesections
Secondary outcome [3] 311971 0
Comparison of intra-individual pre-analytical glucose loss using lithium heparin blood collection tubes.
Timepoint [3] 311971 0
2 hours after each of the two venesections.
Secondary outcome [4] 311972 0
Comparison of intra-individual pre-analytical glucose loss using lithium heparin blood collection tubes.
Timepoint [4] 311972 0
24 hours after each of the two venesections

Eligibility
Key inclusion criteria
Participants are either healthy volunteers (N=20) or subjects with diabetes attending the local diabetes clinic (N=20)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous history of 'difficult' venesection

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled from local staff (healthy volunteers) and from patients attending the local diabetes clinic (diabetic participants). Once they have donated a blood sample, participants will have no control of blood processing and analysis. Laboratory staff undertaking plasma glucose analysis will analyse de-identified samples.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Method comparison statistics, including Bland Altman comparison of plasma glucose values obtained from blood samples undergoing delayed separation of red cells from plasma, with those samples undergoing immediate separation and are therefore deemed to give accurate glucose values.

A sample size of 40 is considered a minimum number for validation of a new laboratory assay procedure. Also, a previous study published by ourselves (Chan H et al. Plasma glucose measurement in diabetes: impact and implications of variations in sample collection procedures with a focus on the first hour after sample collection, CCLM 2014) was powered to show a clinically significant effect with 62 participants who had their plasma separated <1 hour after collection. We anticipate we will need smaller numbers in a study focusing on a longer time delay when separating plasma from red cells.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/01/2015
Actual
22/01/2015
Date of last participant enrolment
Anticipated
24/08/2015
Actual
24/08/2015
Date of last data collection
Anticipated
Actual
24/08/2015
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 6548 0
New Zealand
State/province [1] 6548 0
Canterbury

Funding & Sponsors
Funding source category [1] 290417 0
Charities/Societies/Foundations
Name [1] 290417 0
Diabetes Christchurch
Country [1] 290417 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Lunt
Address
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 289133 0
Other
Name [1] 289133 0
Canterbury Health Laboratories
Address [1] 289133 0
Hagley Ave
Addington 8011
Christchurch
Country [1] 289133 0
New Zealand
Secondary sponsor category [2] 289134 0
University
Name [2] 289134 0
University of Otago, Christchurch
Address [2] 289134 0
2 Riccarton Avenue, Christchurch Central, Christchurch 8011
Country [2] 289134 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292105 0
HDEC
Ethics committee address [1] 292105 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 292105 0
New Zealand
Date submitted for ethics approval [1] 292105 0
18/12/2014
Approval date [1] 292105 0
23/12/2014
Ethics approval number [1] 292105 0
14/STH/220
Ethics committee name [2] 292158 0
HDEC
Ethics committee address [2] 292158 0
Ethics committee country [2] 292158 0
New Zealand
Date submitted for ethics approval [2] 292158 0
Approval date [2] 292158 0
Ethics approval number [2] 292158 0

Summary
Brief summary
Accurate estimation of laboratory plasma glucose is important for the screening, diagnosis and management of several conditions, including diabetes. One of the reasons why laboratory plasma glucose results may not be accurate relates to in vitro glycolysis i.e. glucose is lost due to red cell uptake of glucose, if red cells are not separated immediately from plasma, following venesection. Routinely available blood collection tubes are not good glycolysis inhibitors. A 'new' citrate/fluoride blood collecting system, manufactured by Terumo, is thought to be much better at inhibiting glycolysis. Published information is however limited and there is virtually no information available from study participants with hyperglycaemia. The current study aims to compare pre-analytical glucose loss using the 'new' collection system with the systems already in routine use. The study also aims to compare intra-individual rates of glycolysis. If rates of glycolysis are similar both between and also within participants, then it may be possible to apply a correction factor when undertaking comparisons of serial glucose values across 'old' and 'new' collection systems.
Trial website
Trial related presentations / publications
Carey, R., Lunt, H., Heenan, H. F., Frampton, C. M. A., & Florkowski, C. M. (2016). Collection tubes containing citrate stabiliser over-estimate plasma glucose, when compared to other samples undergoing immediate plasma separation. Clinical Biochemistry. Advance online publication. doi: 10.1016/j.clinbiochem.2016.05.017
Public notes

Contacts
Principal investigator
Name 53526 0
A/Prof Helen Lunt
Address 53526 0
Diabetes Centre
550 Hagley Ave
Riccarton 8011
Christchurch
Country 53526 0
New Zealand
Phone 53526 0
+64 3 3640860
Fax 53526 0
+64 3 3640171
Email 53526 0
[email protected]
Contact person for public queries
Name 53527 0
A/Prof Helen Lunt
Address 53527 0
Diabetes Centre
550 Hagley Ave
Riccarton 8011
Christchurch
Country 53527 0
New Zealand
Phone 53527 0
+64 3 3640860
Fax 53527 0
Email 53527 0
[email protected]
Contact person for scientific queries
Name 53528 0
A/Prof Helen Lunt
Address 53528 0
Diabetes Centre
550 Hagley Ave
Riccarton 8011
Christchurch
Country 53528 0
New Zealand
Phone 53528 0
+64 3 3640860
Fax 53528 0
Email 53528 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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