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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Natural history
Convenience sample
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4017 0
Self funded/Unfunded
Name [1] 4017 0
Greg Roberts
Address [1] 4017 0
Pharmacy Dept
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country [1] 4017 0
Primary sponsor type
Repatriation General Hospital
Daws Road, Daw Park SA 5041
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

Ethics approval
Ethics application status
Ethics committee name [1] 6098 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 6098 0
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Ethics committee country [1] 6098 0
Date submitted for ethics approval [1] 6098 0
Approval date [1] 6098 0
Ethics approval number [1] 6098 0

Brief summary
When people with airways disease have flare-ups in their disease they are often admitted to hospital and receive high doses of an anti-inflammatory drug (prednisolone) as treatment. This drug can increase the patient's blood sugar levels, even in those who are not diabetics. This temporary increase in sugar evels may slow the patient from recovery. We are measuring the effect of prednisolone on blood sugar levels in the hope that we can identify a way to manage the sugar levels and keep them in the normal range when a patient receives high doses of prednisolone. If we managed to achieve this, then we may be able to speed up the recovery of the patient.
Trial website
Trial related presentations / publications
Burt MG, Roberts GW, Aguilar-Loza NR, Frith P, Stranks SN. Continuous monitoring of circadian glycemic patterns in patients receiving prednisolone for COPD. J Clin Endocrinol Metab 2011; 96:1789-1796.
Public notes

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
Phone 29044 0
61 8 82046936
Fax 29044 0
Email 29044 0
Contact person for public queries
Name 12201 0
Mr Greg Roberts
Address 12201 0
Pharmacy Dept
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 12201 0
Phone 12201 0
+61 8 82751632
Fax 12201 0
Email 12201 0
Contact person for scientific queries
Name 3129 0
Mr Greg Roberts
Address 3129 0
Pharmacy Dept
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 3129 0
Phone 3129 0
+61 8 82751632
Fax 3129 0
Email 3129 0

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