Bolus Insulin Card Calculator Randomised Controlled Study
1 other identifier
interventional
150
1 country
5
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 8, 2010
August 1, 2009
2.6 years
September 5, 2008
February 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24 hours BGL > 8.3mmol/l (CGMS)
3 months
Secondary Outcomes (1)
HbA1c
3 months
Study Arms (2)
Fixed dose
ACTIVE COMPARATORFixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin.
ezy-BICC dose calculation card
EXPERIMENTALvariable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin.
Interventions
small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject
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
Eligibility Criteria
You may qualify if:
- Age 11 - 18 years old
- Currently using indvidual subcutaneous injections (not CSII)
You may not qualify if:
- HbA1c \> 9.5%
- Serious illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- John Hunter Children's Hospitallead
- Royal North Shore Hospitalcollaborator
- Sydney Children's Hospitals Networkcollaborator
- Royal Children's Hospitalcollaborator
- Lady Cilento Children's Hospital, Brisbanecollaborator
- NovoNordisk Pharmaceuticalscollaborator
Study Sites (5)
Gosford District Hospital
Gosford, New South Wales, 2915, Australia
John Hunter Children's Hospital
Newcastle, New South Wales, 2305, Australia
Sydney Children's Hospital
Sydney, New South Wales, Australia
Mater Children's Hospital
Brisbane, Queensland, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 8, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2010
Study Completion
January 1, 2011
Last Updated
February 8, 2010
Record last verified: 2009-08