Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000336280
Ethics application status
Approved
Date submitted
15/04/2009
Date registered
22/05/2009
Date last updated
22/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Basal-bolus insulin versus sliding scale insulin for managing blood sugar levels in hospitalized diabetic patients
Scientific title
Hospitalized diabetic patients undergoing basal-bolus insulin versus sliding scale management for control of blood glucose levels
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inpatient blood glucose management 4597 0
Condition category
Condition code
Metabolic and Endocrine 4893 4893 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Basal-bolus insulin management via subcuteous injection is now recommended for inpatient glycaemic control. This replaces the old subcutaneous injection sliding scale insulin management approach. This study will prospectively collect performance data around a basal-bolus insulin approach developed at this hospital and compare it to retrospective data around the use of sliding scale insulin management at the hospital. Four times daily capillary blood glucose will be recorded in each group.
Subcutaneous sliding scale insulin is initiated at the doctors discretion and the quantitative adjustment within the sliding scale is empirical, depending on what insulin doses the doctor feels are appropriate for that particular patient. Frequency of insuin administration is generally four times daily but may vary. This is continued until either discharge or the treating doctor feels the patient will maintain satisfactory glycaemic control without sliding scale insulin intervention, with a maximum data collection of 1 week. This data will be collected retrospectively as the hospital has now switched over to a basal-bolus insulin management approach.
The basal-bolus insulin management (via subcutaneous injection) is intiated at the discretion of the treating doctor. An initial daily insulin dose is calculated according to set criteria, and 50% of this is then divided into a basal (glargine) dose administered once daily and 50% to rapid-acting insulin split into bolus doses three times daily prior to each meal +/- a small dose of correctional insulin depending on the blood glucose level at the time. This is continued until either discharge or the treating doctor feels the patient will maintain satisfactory glycaemic control without basal-bolus insulin intervention, with a maximum data collection of 1 week.
Intervention code [1] 236621 0
Not applicable
Comparator / control treatment
Patients previously admitted to the hospital who had glycaemic control managed using sliding scale insulin. Data will be collected from the period January 06 to August 07
Control group
Historical

Outcomes
Primary outcome [1] 5744 0
Mean daily blood glucose. This is taken by using the mean of the routine four times daily capillary blood glucose readings taken by nursing staff for each patient, using a standardized point-of-care glucometer. The study is powered to detect a mean daily difference of 2mmol/L.Comparison will be via Student t-test
Timepoint [1] 5744 0
Capillary blood glucose performed four times daily. Patients maintained on either basal-bolus or sliding scale at doctors discretion, usually 3-14 days.
Secondary outcome [1] 241693 0
Daily proportion of blood glucose readings in desirable range (4-10mmol/L).This is calculated by utilising the routine four times daily capillary blood glucose readings taken by nursing staff for each patient, using a standardized point-of-care glucometer. Comparison will be via Chi-square.
Timepoint [1] 241693 0
Capillary blood glucose performed four times daily. Patients maintained on either basal-bolus or sliding scale at doctors discretion, usually 3-14 days.

Eligibility
Key inclusion criteria
Any diabetic patient admitted to the hospital requiring either basal-bolus insulin or sliding scale insulin for intensification of glycaemic control.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4998 0
Commercial sector/Industry
Name [1] 4998 0
Sanofi-Aventis
Country [1] 4998 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park, SA 5041
Country
Australia
Secondary sponsor category [1] 4317 0
Government body
Name [1] 4317 0
South Australian Department of Health
Address [1] 4317 0
Grenfell St
Adelaide SA 5000
Country [1] 4317 0
Australia
Secondary sponsor category [2] 4519 0
None
Name [2] 4519 0
Address [2] 4519 0
Country [2] 4519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7100 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 7100 0
Repatriation General Hospital
Daws Road
Daw Park, SA 5041
Ethics committee country [1] 7100 0
Australia
Date submitted for ethics approval [1] 7100 0
Approval date [1] 7100 0
10/12/2007
Ethics approval number [1] 7100 0
AUD020/07GR

Summary
Brief summary
While basal-bolus insulin management is preferred over sliding scale for glycaemic control of hospitalised diabetics requiring intensified glycaemic control, there are no recommended basal-bolus approaches, and little data comparing the 2 approaches. The development of our basal-bolus approach requires testing to ensure its clinical efficacy, and that it is actually a better practice than sliding scale insulin. The main comparator will be the mean daily glucose readings taken from the routine four times daily capillary blood glucose measurements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29488 0
Address 29488 0
Country 29488 0
Phone 29488 0
Fax 29488 0
Email 29488 0
Contact person for public queries
Name 12735 0
Greg Roberts
Address 12735 0
Pharmacy Dept
Repatriation General Hospital
Daws Rd, Daw Park SA 5041
Country 12735 0
Australia
Phone 12735 0
+61 8 82751632
Fax 12735 0
Email 12735 0
[email protected]
Contact person for scientific queries
Name 3663 0
Greg Roberts
Address 3663 0
Pharmacy Dept
Repatriation General Hospital
Daws Rd, Daw Park SA 5041
Country 3663 0
Australia
Phone 3663 0
+61 8 82751632
Fax 3663 0
Email 3663 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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