Bolus Insulin Card Calculator Randomised Controlled Study
Not Applicable
- Conditions
- Type 1 Diabetes
- Interventions
- Other: Fixed doseDevice: ezy-BICC dose calculation card
- Registration Number
- NCT00748137
- Lead Sponsor
- John Hunter Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Age 11 - 18 years old
- Currently using indvidual subcutaneous injections (not CSII)
Exclusion Criteria
- HbA1c > 9.5%
- Serious illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fixed dose Fixed dose Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin. ezy-BICC dose calculation card ezy-BICC dose calculation card variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin.
- Primary Outcome Measures
Name Time Method 24 hours BGL > 8.3mmol/l (CGMS) 3 months
- Secondary Outcome Measures
Name Time Method HbA1c 3 months
Trial Locations
- Locations (5)
Sydney Children's Hospital
🇦🇺Sydney, New South Wales, Australia
John Hunter Children's Hospital
🇦🇺Newcastle, New South Wales, Australia
Mater Children's Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Children's Hospital
🇦🇺Brisbane, Queensland, Australia
Gosford District Hospital
🇦🇺Gosford, New South Wales, Australia