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Trial registered on ANZCTR


Registration number
ACTRN12608000125325
Ethics application status
Not yet submitted
Date submitted
28/02/2008
Date registered
10/03/2008
Date last updated
10/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Comparison of Peri-Operative and Post Acute Coronary Syndrome Glycaemic Control in Insulin Requiring Patients with Type 2 Diabetes at St Vincent’s Hospital With and Without Real-Time Continuous Glucose Monitoring.
Scientific title
In patients with type 2 diabetes treated with insulin, who are post-operative or post acute coronary syndrome, does real-time continuous glucose monitoring vs intermittant finger pricks improve glucose control.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes requiring insulin 2780 0
Acute coronary syndromes 2781 0
Post - operative patients 2782 0
Condition category
Condition code
Metabolic and Endocrine 2914 2914 0 0
Diabetes
Cardiovascular 2915 2915 0 0
Coronary heart disease
Surgery 2916 2916 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real-Time Continuous glucose monitoring with Guardian Real-Time where glucose levels are displayed on the monitor every 5 minutes. If the levels are falling at >2mmol/20minutes or similarly rising at that rate, the monitor will alarm and thus appropriate interventions can be carried. Before any intervention is taken, the levels displayed are confirmed with a finger prick test. Subjects will be fitted with this monitor after surgery or the coronary event and will wear it up to 3 days post-event.
Intervention code [1] 2520 0
Treatment: Other
Comparator / control treatment
Intermittant glucose testing with finger pricks that will be carried out 4-6 times a day. The results obtained will require appropriate action as specified by the hospital's existing protocol for post-operative glucose control. Subjects here will also be fitted with the continuous glucose monitor but it will be blinded so as not to reveal the levels but rather to store it for retrospective comparison. Subjects will be monitored for a period up to 3 days from the event.
Control group
Active

Outcomes
Primary outcome [1] 3795 0
Time spent in the target glycaemic range, time spent in hypoglycaemic range and time spent in the hyperglycaemic range. These outcomes are measured from the data stored in the continuous glucose monitors and will be accessed via a corresponding computer programme.
Timepoint [1] 3795 0
1 to 3 days post event.
Secondary outcome [1] 6406 0
Glucose variablility as will be determined using Continuous Overlapping Net Glycaemia Action (CONGA).
Timepoint [1] 6406 0
1 to 3 days post event

Eligibility
Key inclusion criteria
Type 2 diabetes requiring insulin, patients who are post operative or post acute coronary syndromes.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on corticosteraids, patients requiring renal dialysis and patients admitted to Intensive Care Unit.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple radomisation using coin tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 747 0
3065

Funding & Sponsors
Funding source category [1] 3041 0
Hospital
Name [1] 3041 0
St VIncent's Hospital Research Endowment Fund
Country [1] 3041 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
41 Victoria Parade
Fitzroy Melbourne VIC 3065
Country
Australia
Secondary sponsor category [1] 2741 0
None
Name [1] 2741 0
Address [1] 2741 0
Country [1] 2741 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4994 0
Ethics committee address [1] 4994 0
Ethics committee country [1] 4994 0
Date submitted for ethics approval [1] 4994 0
31/01/2008
Approval date [1] 4994 0
Ethics approval number [1] 4994 0

Summary
Brief summary
In patients with type 2 diabetes, it is proven that good glucose control during stressful events like after surgery and after a heart attack helps improve the outcome. Therefore in patients with type 2 diabetes requiring insulin and undergoing stressful events, real-time continuous glucose monitoring which provides detailed information on the glucose trends may improve glucose control compared with intermittant glucose monitoring with finger pricks shich are "snap shots" of the ever fluctuating glucose level.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28343 0
Address 28343 0
Country 28343 0
Phone 28343 0
Fax 28343 0
Email 28343 0
Contact person for public queries
Name 11500 0
Dr Veena Roberts
Address 11500 0
St Vincent's Hospital
41 Victoria Parade
Fitzroy Melbourne VIC 3065
Country 11500 0
Australia
Phone 11500 0
+61 3 92882211
Fax 11500 0
Email 11500 0
[email protected]
Contact person for scientific queries
Name 2428 0
Dr. David O'Neal
Address 2428 0
Clinical Sciences Building
St Vincent's Hospital
41 Victoria Parade
Fitzroy Melbourne VIC 3065
Country 2428 0
Australia
Phone 2428 0
+61 3 92882574
Fax 2428 0
+61 3 92882581
Email 2428 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

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

Documents added automatically
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