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Trial registered on ANZCTR


Registration number
ACTRN12612000817842
Ethics application status
Approved
Date submitted
1/08/2012
Date registered
3/08/2012
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Date results information initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of steroid-induced diabetes in hospitalized patients
Scientific title
Randomized-controlled study of isophane and aspart insulin versus glargine and aspart insulin to treat prednisolone-induced hyperglycaemia in hospitalized patients
Secondary ID [1] 280948 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prednisolone-induced hyperglycaemia 287043 0
Condition category
Condition code
Metabolic and Endocrine 287370 287370 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Update
Isophane insulin once daily and aspart insulin 3 times a day administered subcutaneously for up to 7 days. Subjects not treated with insulin prior to enrolment will initially receive a total daily insulin dose of 0.5 U/kg. Subjects receiving insulin prior to enrolment in the study will receive 130% of their current daily dose of insulin or 0.5 U/kg/day (whichever is greater). Insulin isophane will comprise 50% of the total daily dose and insulin aspart 50% of total daily dose with 20% of this dose administered before breakfast, 40% at lunch and 40% at dinner.

Insulin dose adjustment will be carried out once daily by the study team using a designated protocol based on finger prick BGLs. Appropriate insulin doses will be increased by 2 units if BGL 10-15 mmol/L, 4 units if BGL 15-20 mmol/L and 6 units if >20 mmol/L. Insulin dose will be reduced by 2 units if the BGL is 2.8-4 mmol/L and 4 units if the BGL is <2.8 mmol/L or there is symptomatic hypoglycaemia. If there is severe hypoglycaemia the study team may either reduce the insulin dose by 50% or cease insulin.

Isophane doses will be adjusted if fasting glucose is not within the target range (4-10 mmol/L). If individual blood glucose concentrations before lunch, dinner or at 21.00 are outside target, then the insulin aspart dose before the previous meal will be adjusted.
Intervention code [1] 285381 0
Treatment: Drugs
Comparator / control treatment
Glargine insulin once daily and aspart insulin 3 times a day administered subcutaneously for up to 7 days. Subjects not treated with insulin prior to enrolment will initially receive a total daily insulin dose of 0.5 U/kg. Subjects receiving insulin prior to enrolment in the study will receive 130% of their current daily dose of insulin or 0.5 U/kg/day (whichever is greater). Insulin glargine will comprise 50% of the total daily dose and insulin aspart 50% of total daily dose with one third of this dose administered before each meal.

Insulin dose adjustment will be carried out once daily by the study team using a designated protocol based on finger prick BGLs. Appropriate insulin doses will be increased by 2 units if BGL 10-15 mmol/L, 4 units if BGL 15-20 mmol/L and 6 units if >20 mmol/L. Insulin dose will be reduced by 2 units if the BGL is 2.8-4 mmol/L and 4 units if the BGL is <2.8 mmol/L or there is symptomatic hypoglycaemia. If there is severe hypoglycaemia the study team may either reduce the insulin dose by 50% or cease insulin.

Insulin glargine dose will be adjusted based on fasting glucose concentration and insulin aspart doses based on the glucose concentration before the previous meal.
Control group
Active

Outcomes
Primary outcome [1] 287645 0
Time outside glucose concentration target range of 4-10 mmol/L. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).
Timepoint [1] 287645 0
First 24 hours of insulin treatment
Secondary outcome [1] 298573 0
Mean glucose concentration. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).
Timepoint [1] 298573 0
First 24 hours of insulin treatment
Secondary outcome [2] 298574 0
Glucose < 4 mmol/L. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).
Timepoint [2] 298574 0
First 24 hours of insulin treatment
Secondary outcome [3] 298575 0
Glucose < 2.8 mmol/L. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).
Timepoint [3] 298575 0
First 24 hours of insulin treatment

Eligibility
Key inclusion criteria
1. Prednisolone >20 mg/day for acute treatment of an inflammatory or autoimmune disease
2. Hyperglycaemia requiring institution of insulin therapy or higher insulin doses
- one finger prick BGL >15 mmol/L
- two finger prick BGLs >10 mmol/L within 24 hours
3. Expected to stay in hospital > 48 hours
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes mellitus
2. Patients with an acute psychiatric illness
3. Patients unable to consent
4. Patients on existing oral corticosteroids > 5mg prednisolone/day or equivalent
5. Prolonged fasting
6. Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A member of the study team will screen the diagnoses of new hospital admissions for patients likely to be treated with prednisolone and then check if these subjects have hyperglycaemia. Patients that meet inclusion criteria will be approached by a member of the study team who is not involved in the potential participants usual care and given a patient information sheet. Subjects will be randomized using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients previously treated with insulin before admission and non-insulin-treated patients will be block randomized separately using numbered containers to one of two insulin regimens.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2012
Actual
9/08/2012
Date of last participant enrolment
Anticipated
Actual
15/07/2016
Date of last data collection
Anticipated
Actual
19/07/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285736 0
University
Name [1] 285736 0
Flinders University
Country [1] 285736 0
Australia
Primary sponsor type
Individual
Name
Dr Morton Burt
Address
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 284561 0
University
Name [1] 284561 0
Flinders University
Address [1] 284561 0
Sturt Road
Bedford Park SA 5042
Country [1] 284561 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287740 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287740 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 287740 0
Australia
Date submitted for ethics approval [1] 287740 0
Approval date [1] 287740 0
23/04/2012
Ethics approval number [1] 287740 0
18/12/2012

Summary
Brief summary
The aim is to determine whether an insulin regimen specific for prednisolone-induced hyperglycaemia is safer and more efficacious than basal bolus insulin, the current regimen commonly used in many hospitals. As we have previously showm that prednisolone predominantly increases blood glucose between midday and midnight, we hypothesize that delivering the majority of insulin during this time period and less insulin between midnight and breakfast will reduce nocturnal hypoglycaemia and better treat postprandial hyperglycaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34514 0
A/Prof Morton Burt
Address 34514 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation general Hospital
Daws Rd
Daw Park SA 5041
Country 34514 0
Australia
Phone 34514 0
08 82751094
Fax 34514 0
Email 34514 0
[email protected]
Contact person for public queries
Name 17761 0
Dr Morton Burt
Address 17761 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 17761 0
Australia
Phone 17761 0
+61 8 82751094
Fax 17761 0
Email 17761 0
[email protected]
Contact person for scientific queries
Name 8689 0
Dr Morton Burt
Address 8689 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 8689 0
Australia
Phone 8689 0
+61 8 82751094
Fax 8689 0
Email 8689 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Requires ethics approval.


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 Radhakutty A, Stranks JL, Mangelsdorf BL, Drake SM... [More Details] 362836-(Uploaded-04-12-2018-09-14-42)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTreatment of prednisolone-induced hyperglycaemia in hospitalized patients: Insights from a randomized, controlled study.2017https://dx.doi.org/10.1111/dom.12859
N.B. These documents automatically identified may not have been verified by the study sponsor.