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Trial registered on ANZCTR


Registration number
ACTRN12616001692426
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
8/12/2016
Date last updated
8/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Studies of Glucocorticoid Induced Hyperglycaemia - Part 1: effects of commonly prescribed Glucocorticoid (GC) regimens on blood sugar levels
Scientific title
Continuous glucose monitoring to profile the effects of Glucocorticoid regimens on glycaemia.
Secondary ID [1] 290336 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 300606 0
Hyperglycaemia 300607 0
Condition category
Condition code
Metabolic and Endocrine 300456 300456 0 0
Diabetes
Reproductive Health and Childbirth 300996 300996 0 0
Antenatal care
Renal and Urogenital 300997 300997 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To use continuous glucose monitoring (CGM) to profile the glycemic impact of commonly prescribed Glucocorticoid (GC) regimens. CGM will be applied for 3 days prior to the first dose of GC and continued for 3 days following GC administration at per the prescribed dose frequency (total duration 6 days)
Intervention code [1] 296148 0
Not applicable
Comparator / control treatment
Internal control; continuous glucose monitoring before and after administration of glucocorticoid
Control group
Active

Outcomes
Primary outcome [1] 299893 0
Peak interstitial fluid glucose induced by glucocorticoid administration, detected by CGM
Timepoint [1] 299893 0
Within 24 hours of each dose of glucocorticoid administered.
Secondary outcome [1] 328404 0
Nadir glucose detected by CGM
Timepoint [1] 328404 0
Within 24 hours of each dose of glucocorticoid administered, detected by CGM
Secondary outcome [2] 328405 0
glycemic variability as assessed by the J-index calculated from CGM traces
Timepoint [2] 328405 0
24 hours post each dose of glucocorticoid administered
Secondary outcome [3] 328406 0
Incidence of hyperglycaemia defined by the time spent with glucose greater than 7.8mmol/L during each 24 hour period post glucocorticoid administration
Timepoint [3] 328406 0
Within 24 hours of glucocorticoid administration
Secondary outcome [4] 328407 0
Use of diabetes therapy as documented in the medical record
Timepoint [4] 328407 0
24 hours post glucocorticoid administration
Secondary outcome [5] 328408 0
Incidence of hypoglycaemia defined by time spent with glucose <4mmol/L during each 24 hour period post glucocorticoid administration
Timepoint [5] 328408 0
24 hours post glucocorticoid administration

Eligibility
Key inclusion criteria
Patients with and without diabetes who are planned to have glucocorticoids for a medical indication.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects under the age of 18, subjects whose primary language is other than English, subjects with a cognitive impairment, an intellectual disability or a mental illness

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be percentages for categorical data, mean +/- SD for normally distributed continuous data and median (interquartile range (IQR)) for non-normally distributed continuous or ordinal data. Paired and unpaired t-tests will be used to detect the differences in glycaemia and glycaemic variability between GC therapy and no GC therapy. The Wilcoxon rank test will be used to detect differences in ordinal data. Area under the glucose concentration-time curve will be measured using the trapezoidal rule. Results will be calculated using GraphPad Prism version 6.0a for Mac OS X, GraphPad Software (La Jolla California, USA). P values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/12/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6937 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 6938 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 6939 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 14619 0
3050 - Parkville
Recruitment postcode(s) [2] 14620 0
3021 - St Albans
Recruitment postcode(s) [3] 14621 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 294979 0
Hospital
Name [1] 294979 0
Western Health Dept Diabetes and Endocrinology
Country [1] 294979 0
Australia
Funding source category [2] 294980 0
Hospital
Name [2] 294980 0
Royal Melbourne Hospital
Country [2] 294980 0
Australia
Primary sponsor type
Hospital
Name
Western Health Dept Diabetes and Endocrinology
Address
Dept Diabetes and Endocrinology
Furlong Rd
St Albans
VIC 3021
Country
Australia
Secondary sponsor category [1] 293801 0
Hospital
Name [1] 293801 0
Melbourne Health
Address [1] 293801 0
Dept Diabetes and Endocrinology
Grattan St
Parkville
VIC 3050
Country [1] 293801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296336 0
MHHREC
Ethics committee address [1] 296336 0
Ethics committee country [1] 296336 0
Australia
Date submitted for ethics approval [1] 296336 0
27/04/2016
Approval date [1] 296336 0
05/09/2016
Ethics approval number [1] 296336 0
HREC/16/MH/128 - 2016.117

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

Contacts
Principal investigator
Name 69698 0
Dr Christopher Yates
Address 69698 0
Dept Diabetes and Endocrinology
Royal Melbourne Hospital
Grattan St
Parkville
VIC 3050
Country 69698 0
Australia
Phone 69698 0
+61 3 93427000
Fax 69698 0
Email 69698 0
christopher.yates@mh.org.au
Contact person for public queries
Name 69699 0
Christopher Yates
Address 69699 0
Dept Diabetes and Endocrinology
Royal Melbourne Hospital
Grattan St
Parkville
VIC 3050
Country 69699 0
Australia
Phone 69699 0
+61 3 93427000
Fax 69699 0
Email 69699 0
christopher.yates@mh.org.au
Contact person for scientific queries
Name 69700 0
Christopher Yates
Address 69700 0
Dept Diabetes and Endocrinology
Royal Melbourne Hospital
Grattan St
Parkville
VIC 3050
Country 69700 0
Australia
Phone 69700 0
+61 3 93427000
Fax 69700 0
Email 69700 0
christopher.yates@mh.org.au

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.