Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Youth, Insulin dose
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.
Interventions
DEVICEezy-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
OTHERFixed 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
Sponsors
Royal North Shore Hospital
Sydney Children's Hospitals Network
Royal Children's Hospital
Lady Cilento Children's Hospital, Brisbane
NovoNordisk Pharmaceuticals
John Hunter Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 11 - 18 years old * Currently using indvidual subcutaneous injections (not CSII)
Exclusion criteria
* HbA1c \> 9.5% * Serious illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hours BGL > 8.3mmol/l (CGMS) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | 3 months |
Countries
Australia
Contacts
Primary ContactDonald Anderson, FRACP
Backup ContactElizabeth Nunn, BSc
Outcome results
None listed