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Trial registered on ANZCTR


Registration number
ACTRN12610000957099
Ethics application status
Not yet submitted
Date submitted
8/11/2010
Date registered
9/11/2010
Date last updated
9/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to assess the contribution of various blood samples and sampling techniques to the performance of a Self Monitoring Blood Glucose System.
Scientific title
In patients with type 1 or 2 diabetes, how do glucose results from a Self Monitoring Blood Glucose System correlate with that of a standard laboratory reference using different sampling techniques.
Secondary ID [1] 253045 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
A glucose test used to monitor blood glucose results in patients diagnosed with diabetes 258608 0
Condition category
Condition code
Metabolic and Endocrine 258753 258753 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to measure glucose levels in persons currently being treated for type 1 or 2 diabetes.
Each participant will be required to donate 1 venous whole blood sample additional to their routine treatment and two capillary finger stick samples which are not performed as a part of their normal treatment.
Venous and capillary blood samples will be tested directly on a self monitoring blood glucose system as well as a reference method.
Results from the self monitoring blood glucose system will be analysed in comparison to the reference method.
No clinical decision will be made from data generated using the investigational device.
Participants will be recruited over 10 days.
Intervention code [1] 257570 0
Other interventions
Comparator / control treatment
No treatments are administered as part of this study. This study does not include a control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259612 0
Glucose values from the device will correlate with results obtained from a laboratory test method
Timepoint [1] 259612 0
Glucose results from the laboratory method and device will be recorded immediately.
Secondary outcome [1] 266258 0
That various blood samples and sampling techniques will contribute to the performance of the device.
Timepoint [1] 266258 0
Glucose results from the laboratory method and device will be recorded immediately.

Eligibility
Key inclusion criteria
Patients are required to be currently treated for type 1 or 2 diabetes and require a venous blood sample as part of their routine treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant females, completed a D-Xylose Gut Absorption test within the last 2 days. Haematocrit and glucose to be within the acceptable range of the device

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258025 0
Commercial sector/Industry
Name [1] 258025 0
Universal Biosensors Pty Ltd
Address [1] 258025 0
1 Corporate Ave.
Rowville, VIC 3178
Country [1] 258025 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Universal Biosensors Pty Ltd
Address
1 Corporate Ave.
Rowville, VIC 3178
Country
Australia
Secondary sponsor category [1] 257217 0
None
Name [1] 257217 0
Address [1] 257217 0
Country [1] 257217 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260018 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 260018 0
55 Commercial Road
Melbourne, VIC, 3004
Ethics committee country [1] 260018 0
Australia
Date submitted for ethics approval [1] 260018 0
24/11/2010
Approval date [1] 260018 0
Ethics approval number [1] 260018 0

Summary
Brief summary
This study will involve taking a venous sample from the same venepuncture uses as a part of their normal routine treatment and an additional two capillary finger stick samples from all participants. Samples collected are tested on both the medical device and the laboratory reference.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31886 0
Address 31886 0
Country 31886 0
Phone 31886 0
Fax 31886 0
Email 31886 0
Contact person for public queries
Name 15133 0
Ms Kristyn Forsayeth
Address 15133 0
1 Corporate Ave.
Rowville, VIC, 3178
Country 15133 0
Australia
Phone 15133 0
+61 3 9213 9000
Fax 15133 0
Email 15133 0
kforsayeth@universalbiosensors.com
Contact person for scientific queries
Name 6061 0
Dr Ilona Pillai
Address 6061 0
1 Corporate Ave.
Rowville, VIC, 3178
Country 6061 0
Australia
Phone 6061 0
+61 3 9213 9000
Fax 6061 0
Email 6061 0
ipillai@universalbiosensors.com

No information has been provided regarding IPD availability
Summary results
No Results