Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001211257
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
19/07/2018
Date last updated
17/03/2023
Date data sharing statement initially provided
25/06/2019
Date results information initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors affecting insulin dose requirements for treatment of prednisolone induced hyperglycaemia.
Scientific title
Determination of clinical factors that influence insulin dose requirements during treatment of hyperglycaemia while taking prednisolone
Secondary ID [1] 295458 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prednisolone induced hyperglycaemia 308711 0
Insulin resistance 308712 0
Condition category
Condition code
Metabolic and Endocrine 307651 307651 0 0
Diabetes
Metabolic and Endocrine 307652 307652 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of short-acting neutral insulin (Atrapid) via insulin infusion for total duration of 24 hours in participants who have been prescribed prednisolone and are experiencing hyperglycaemia. Insulin infusion will comprise 50 units of Actrapid insulin pre-mixed with 50ml of normal saline. Starting rate of insulin infusion will be based on participant blood glucose level and based on the Flinders Medical Centre insulin infusion protocol. Insulin infusion will be commenced if hyperglycaemia is identified following prednisolone administration. Hyperglycaemia is classified as one point-of-care capillary glucose level > 15 mmol/L or two point-of-care capillary glucose levels > 10 mmol/L.
Intervention code [1] 301769 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306712 0
The primary outcome is to define, in hospitalised patients with hyperglycaemia taking acute prednisolone, the clinical features associated with daily insulin dosing requirements.
This study is not designed to evaluate the efficacy of intravenous insulin infusions in managing prednisolone induced hyperglycemia, rather insulin infusion is an intervention that will be used to evaluate total participant insulin requirements.
Clinical features of interest include:
1. Prednisolone dose administered on day of insulin infusion administration
2. Age, assessed by taking participant medical history
3. Sex, assessed by taking participant medical history
4. Body mass index assessed by measuring participant height and weight during physical examination
5. Waist circumference assessed as measurement during physical examination
6. Co-morbidities assessed by taking participant medical history
7. Glucose concentration on the day prior to starting intravenous insulin infusion, assessed by reviewing participant medical records.
Timepoint [1] 306712 0
All baseline characteristics will be collected up to 24 hours prior to commencing insulin infusion.
Secondary outcome [1] 349320 0
To define, in hospitalized patients with hyperglycaemia taking acute prednisolone insulin dosing requirements during different time periods of the day. Intravenous insulin will be administered as per standard Flinders Medical Centre insulin infusion protocol. Hourly insulin infusion rates will be recorded on study specific record form.
Timepoint [1] 349320 0
Insulin infusion rates will be recorded on an hourly basis for a total of 24 hours (i.e. 0 hours, 1 hour post infusion commencement, 2 hours post infusion commencement, 3 hours post infusion commencement, until 24 hours post infusion commencement is reached).

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Prescribed a morning dose of oral prednisolone greater than or equal to 20 mg/day for an acute inflammatory illness.
3. Hyperglycaemia in the prior 24 hours, defined as:
A) One point-of-care blood glucose greater than or equal to 15 mmol/L.
B) Two point-of-care blood glucose greater than or equal to 10 mmol/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nil by mouth or reduced oral intake.
2. Type 1 diabetes mellitus (T1DM).
3. Prescribed long-term oral prednisolone greater than or equal to 10 mg/day (or equivalent).
4. Psychiatric illness or another condition precluding providing informed consent.
5. Pregnancy.

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The association between variables and daily insulin dose will be assessed in linear regression analyses with mean glucose during the study period as a co-variate. Variables that are significantly associated with daily insulin dose in these analyses will then be incorporated into a multivariable linear regression analysis. Fifty participants will provide 80% power to detect an association with r-value 0.4 at the two-tailed 0.05 significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2018
Actual
17/06/2019
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/07/2021
Date of last data collection
Anticipated
1/07/2021
Actual
30/08/2021
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11333 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 11334 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 23230 0
5042 - Bedford Park
Recruitment postcode(s) [2] 23231 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 300049 0
University
Name [1] 300049 0
Flinders Centre for Clinical Change and Health Care Research
Country [1] 300049 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Bedford Drive
Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 299442 0
University
Name [1] 299442 0
Flinders University
Address [1] 299442 0
Sturt Rd
Bedford Park, SA, 5042
Country [1] 299442 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300895 0
Southern Adelaide Clinical Research Ethics Commttee
Ethics committee address [1] 300895 0
Flinders Medical Centre
Level 6, Ward C, Room 6A219
Bedford Drive
Bedford Park, SA 5042
Ethics committee country [1] 300895 0
Australia
Date submitted for ethics approval [1] 300895 0
30/03/2018
Approval date [1] 300895 0
30/05/2018
Ethics approval number [1] 300895 0
30.18 HREC/18/SAC/34

Summary
Brief summary
Prednisolone is an oral glucocorticoid used in the acute treatment of many inflammatory diseases. Glucocorticoid excess leads to hyperglycaemia. There is wide variability in the degree of hyperglycaemia associated with oral prednisolone use. We aim to define how clinical features and different times of day are associated with insulin requirement in
hyperglycaemic hospitalised patients taking prednisolone. We will recruit 50 consecutive participants who are admitted to general medical or medical sub-specialty inpatient teams at Flinders Medical Centre or Lyell McEwin Hospital who meet eligibility criteria.
This is an open interventional study. Eligible, consenting participants will receive 24 hours of intravenous insulin infusion. Flash glucose monitoring will be used to measure hourly blood glucose concentration. Use of intravenous insulin infusion will follow Flinders Medical Centre infusion protocol. We expect to be able to characterise how clinical features and time periods throughout the day predict for insulin requirements in hyperglycaemic hospitalised patients taking prednisolone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85194 0
A/Prof Morton Burt
Address 85194 0
Southern Adelaide Diabetes and Endocrine Services
10 Milham Street
Oaklands Park, SA 5046
Country 85194 0
Australia
Phone 85194 0
+6187425 8690
Fax 85194 0
Email 85194 0
[email protected]
Contact person for public queries
Name 85195 0
A/Prof Morton Burt
Address 85195 0
Southern Adelaide Diabetes and Endocrine Services
10 Milham Street
Oaklands Park, SA 5046
Country 85195 0
Australia
Phone 85195 0
+61874258690
Fax 85195 0
Email 85195 0
[email protected]
Contact person for scientific queries
Name 85196 0
A/Prof Morton Burt
Address 85196 0
Southern Adelaide Diabetes and Endocrine Services
10 Milham Street
Oaklands Park, SA 5046
Country 85196 0
Australia
Phone 85196 0
+6187425 8690
Fax 85196 0
Email 85196 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage we have not planned to share individual participant data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Chen AX, Radhakutty A, Zimmermann A, Stranks SN, T... [More Details]
Study results articleYes Only 1 publication to day, a second manuscript fro... [More Details]

Documents added automatically
No additional documents have been identified.