Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000028202
Ethics application status
Approved
Date submitted
16/10/2008
Date registered
16/01/2009
Date last updated
17/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measurement of blood sugar levels after prednisolone
Scientific title
Assessment of the hyperglycaemic effect of high-dose prednisolone used for exacerbations in Chronic Obstructive Pulmonary Disease.
Secondary ID [1] 288166 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 3838 0
Condition category
Condition code
Respiratory 4026 4026 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
use of continuous glucose monitoring to better define the nature of prednisolone induced hyperglycaemia. Each patient will be monitored for up to 3 days and high dose prednisolone is defined as a single daily oral dose of 20mg or more. Interstitual fluid glucose is measured by the continuous glucose monitor, and this is a well known and accurate proxy for blood glucose. We aim to enrol 50 patients and this is expected to take up to 1 year.
Intervention code [1] 3849 0
Early detection / Screening
Comparator / control treatment
Extrapolation of the Hba1c to estimate the mean interstitual glucose level over the prior 3 months. This is done using the equation developed by Nathan et al(Diab Care 31:1473-8, 2008) that converts a Hba1c value into a mean blood glucose reflecting the prior 3 months. In this manner the patient acts as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4928 0
Mean daily interstitual fluid glucose will be measured by a continuous glucose monitor (CGMS Gold by Medtronic)
Timepoint [1] 4928 0
The CGMS unit takes a reading every 5 minutes for up to 3 days
Secondary outcome [1] 8311 0
Postprandial glucose excursions will be recorded by the continuous glucose monitor
Timepoint [1] 8311 0
This will be for 3 days duration ie up to 9 meals during the hospital admission

Eligibility
Key inclusion criteria
Patients experiencing exacerbations in Chronic Obstructive Pulmonary Disease and commenced on high dose prednisolone (>=20mg/day orallly)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/08/2008
Actual
14/08/2008
Date of last participant enrolment
Anticipated
Actual
11/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 4017 0
Self funded/Unfunded
Name [1] 4017 0
Greg Roberts
Country [1] 4017 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 3609 0
Government body
Name [1] 3609 0
Department of Health
Address [1] 3609 0
Citicentre Building, Grenfell Street
Adelaide SA 5000
Country [1] 3609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6098 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 6098 0
Ethics committee country [1] 6098 0
Australia
Date submitted for ethics approval [1] 6098 0
Approval date [1] 6098 0
08/07/2008
Ethics approval number [1] 6098 0
43/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29044 0
Mr Greg Roberts
Address 29044 0
Pharmacy Dept,
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 29044 0
Australia
Phone 29044 0
61 8 82046936
Fax 29044 0
Email 29044 0
[email protected]
Contact person for public queries
Name 12201 0
Greg Roberts
Address 12201 0
Pharmacy Dept
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 12201 0
Australia
Phone 12201 0
+61 8 82751632
Fax 12201 0
Email 12201 0
[email protected]
Contact person for scientific queries
Name 3129 0
Greg Roberts
Address 3129 0
Pharmacy Dept
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 3129 0
Australia
Phone 3129 0
+61 8 82751632
Fax 3129 0
Email 3129 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
No additional documents have been identified.