ANZCTR - Registration

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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prednisolone-induced hyperglycaemia

Condition category

Condition code

Metabolic and Endocrine

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]

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]

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]

First 24 hours of insulin treatment

Secondary outcome [1]

Mean glucose concentration. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).

Timepoint [1]

First 24 hours of insulin treatment

Secondary outcome [2]

Glucose < 4 mmol/L. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).

Timepoint [2]

First 24 hours of insulin treatment

Secondary outcome [3]

Glucose < 2.8 mmol/L. Glucose concentration will be assessed using a continuous glucose monitoring system (iPro2, Medtronics).

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Road
Bedford Park SA 5042

Country [1]

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]

University

Name [1]

Flinders University

Address [1]

Sturt Road
Bedford Park SA 5042

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/04/2012

Ethics approval number [1]

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

A/Prof Morton Burt

Address

Southern Adelaide Diabetes and Endocrine Services
Repatriation general Hospital
Daws Rd
Daw Park SA 5041

Country

Australia

Phone

08 82751094

Fax

morton.burt@sa.gov.au

Contact person for public queries

Name

Dr Morton Burt

Address

Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041

Country

Australia

Phone

+61 8 82751094

Fax

morton.burt@health.sa.gov.au

Contact person for scientific queries

Name

Dr Morton Burt

Address

Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041

Country

Australia

Phone

+61 8 82751094

Fax

morton.burt@health.sa.gov.au

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Treatment of prednisolone-induced hyperglycaemia in hospitalized patients: Insights from a randomized, controlled study.	2017	https://dx.doi.org/10.1111/dom.12859

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically