Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000934943
Ethics application status
Approved
Date submitted
22/08/2011
Date registered
31/08/2011
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of fingerprick blood glucose levels and continuous glucose monitoring to assess high and low blood sugar levels in hospitalized patients treated with basal bolus insulin.
Scientific title
Comparison of fingerprick blood glucose levels and continuous glucose monitoring to assess hyper- and hypoglycaemia in hospitalized patients treated with basal bolus insulin.
Secondary ID [1] 262892 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of glycaemic control in hospitalised diabetic patients 252030 0
diabetes 270620 0
Condition category
Condition code
Metabolic and Endocrine 252222 252222 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Determine whether 4 fingerprick capillary blood glucose levels taken at routine sampling times of 0700, 1200, 1700 and 2100 hours over a 24 hour period during a hospital admission, as measured by standard hospital ward glucometers, accurately reflects glucose concentrations determined by continuous glucose monitoring. The duration of sampling will be up to 2 full consecutive days with a minimum of one full day (midnight to midnight). This will be in a population of known diabetic patients receiving the standard basal bolus insulin regimen, which is used for patients requiring temporary intensified blood glucose management during admission. Patient recruitment is planned until August 2012.
Intervention code [1] 269306 0
Not applicable
Comparator / control treatment
Comparator/Control = continuous glucose monitoring (CGMS).
CGMS involves a small subcutaneous sensor inserted generally in the abdominal region, which detects interstitual glucose concentration, which in turn closely mimicks blood glucose concentration. Readings are automatically performed and stored every 5 minutes, allowing a thorough insight into blood glucose patterns throughout the day. Patients will undergo CGMS monitoring for a minimum of one full 24 hour period (midnight to midnight) to a maximum of two full consecutive 24 hour periods.
Control group
Active

Outcomes
Primary outcome [1] 253092 0
Mean daily glucose concentration
Timepoint [1] 253092 0
Continous glucose monitoring will be performed to include up to two consecutive blocks of 24 hours from midnight to midnight. The device takes a reading every 5 minutes for this period. The continuous glucose monitor will be inserted as soon as practically possible after the patient admission. Routine fingerprick blood glucose will be performed four times daily (at 0700, 1200, 1700 and 2100 hours) while patient is undergoing the continuous glucose monitoring.
Primary outcome [2] 279481 0
mean blood glucose concentration
Timepoint [2] 279481 0
0700, 1200, 1700 and 2100 hours in a 24 hour period
Secondary outcome [1] 257954 0
Prevalence of hypoglycaemia (BGL<4mmol/L) detected by either approach
Timepoint [1] 257954 0
As above. The extent of hypoglycaemia detected by the continuous glucose monitor will be compared to the extent of hypoglycaemia dectected by the routing four times daily fingerprick blood glucose levels.

Eligibility
Key inclusion criteria
Any hospitalised diabetic inpatient requiring basal-bolus managent for glycaemic control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide wrtiien informed consent.
Precluded from CGMS use eg requires MRI or abdo surgery during study period

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
1/12/2008
Date of last participant enrolment
Anticipated
30/10/2010
Actual
30/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243900 0
Charities/Societies/Foundations
Name [1] 243900 0
Foundation Daw Park
Country [1] 243900 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park, SA 5041
Country
Australia
Secondary sponsor category [1] 251243 0
None
Name [1] 251243 0
Address [1] 251243 0
Country [1] 251243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244015 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 244015 0
Repatriation General Hospital
Daws Road,
Daw Park SA 5041
Ethics committee country [1] 244015 0
Australia
Date submitted for ethics approval [1] 244015 0
15/06/2008
Approval date [1] 244015 0
12/08/2008
Ethics approval number [1] 244015 0
43/07

Summary
Brief summary
The aim is to determine whether 4 fingerprick BGLs routinely performed at nominal times of 0700, 1200, 1700 (these three timeslots are just before meals) and 2100 hours accurately assess the efficacy and safety of basal bolus insulin in hospitalized patients.
Trial website
Trial related presentations / publications
Comparison of continuous glucose monitoring and finger-prick blood glucose levels in hospitalised patients administered basal bolus insulin Diabetes Technology and Therapeutics 2013; 15: 241-245.
Public notes

Contacts
Principal investigator
Name 30397 0
Mr Morton Burt
Address 30397 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 30397 0
Australia
Phone 30397 0
61 8 82042374
Fax 30397 0
Email 30397 0
morton.burt@health.sa.gov.au
Contact person for public queries
Name 13644 0
Mr Greg Roberts
Address 13644 0
Pharmacy Department
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 13644 0
Australia
Phone 13644 0
61 8 8275 1632
Fax 13644 0
61 8 8374 0225
Email 13644 0
greg.roberts2@health.sa.gov.au
Contact person for scientific queries
Name 4572 0
Mr Greg Roberts
Address 4572 0
Pharmacy Department
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 4572 0
Australia
Phone 4572 0
61 8 8275 1632
Fax 4572 0
61 8 8374 0225
Email 4572 0
greg.roberts2@health.sa.gov.au

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

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