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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
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Scientific title
Hospitalized diabetic patients undergoing basal-bolus insulin versus sliding scale management for control of blood glucose levels
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inpatient blood glucose management
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Condition category
Condition code
Metabolic and Endocrine
4893
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Not applicable
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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
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Control group
Historical
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Capillary blood glucose performed four times daily. Patients maintained on either basal-bolus or sliding scale at doctors discretion, usually 3-14 days.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Capillary blood glucose performed four times daily. Patients maintained on either basal-bolus or sliding scale at doctors discretion, usually 3-14 days.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
158
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Sanofi-Aventis
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Address [1]
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12-24 Talavera Road
Macquarie Park
NSW 2113
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Repatriation General Hospital
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Address
Daws Road
Daw Park, SA 5041
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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South Australian Department of Health
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Address [1]
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Grenfell St
Adelaide SA 5000
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Country [1]
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Australia
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Secondary sponsor category [2]
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None
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Name [2]
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Repatriation General Hospital Research and Ethics Committee
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Ethics committee address [1]
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Repatriation General Hospital
Daws Road
Daw Park, SA 5041
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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10/12/2007
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Ethics approval number [1]
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AUD020/07GR
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Greg Roberts
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Address
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Pharmacy Dept
Repatriation General Hospital
Daws Rd, Daw Park SA 5041
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Country
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Australia
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Phone
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+61 8 82751632
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Greg Roberts
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Address
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Pharmacy Dept
Repatriation General Hospital
Daws Rd, Daw Park SA 5041
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Country
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Australia
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Phone
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+61 8 82751632
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Fax
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Email
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[email protected]
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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.
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