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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00748137




Registration number
NCT00748137
Ethics application status
Date submitted
5/09/2008
Date registered
8/09/2008
Date last updated
8/02/2010

Titles & IDs
Public title
Bolus Insulin Card Calculator Randomised Controlled Study
Scientific title
Bolus Insulin Card Calculator Randomised Controlled Study
Secondary ID [1] 0 0
06/04/26/5.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ezy-BICC dose calculation card
Other interventions - Fixed dose

Active Comparator: Fixed dose - Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin.

Experimental: ezy-BICC dose calculation card - variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin.


Treatment: Devices: ezy-BICC dose calculation card
small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject

Other interventions: Fixed dose
Approach where study subject is prescribed a set amount of carbohydrate to eat each meal and set dose of rapid acting insulin. Minor modifications may be made if the measured BGL is out of target

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24 hours BGL > 8.3mmol/l (CGMS)
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
- Age 11 - 18 years old

- Currently using indvidual subcutaneous injections (not CSII)
Minimum age
11 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- HbA1c > 9.5%

- Serious illness

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Gosford District Hospital - Gosford
Recruitment hospital [2] 0 0
John Hunter Children's Hospital - Newcastle
Recruitment hospital [3] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [4] 0 0
Mater Children's Hospital - Brisbane
Recruitment hospital [5] 0 0
Royal Children's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2915 - Gosford
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
John Hunter Children's Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal North Shore Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sydney Children's Hospitals Network
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Children's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Lady Cilento Children's Hospital, Brisbane
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
NovoNordisk Pharmaceuticals
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised
controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to
the use of variable size meals and insulin doses determined with a bolus insulin calculation
card.
Trial website
https://clinicaltrials.gov/show/NCT00748137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Donald Anderson, FRACP
Address 0 0
Country 0 0
Phone 0 0
61-2-49855634
Fax 0 0
Email 0 0
donald.anderson@hnehealth.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00748137