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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2011
Actual
Sample size
Target
150
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/ct2/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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00748137