Bolus Insulin Card Calculator Randomised Controlled Study

Type 1 Diabetes Clinical Trial

Official title:

Bolus Insulin Card Calculator Randomised Controlled Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00748137
• Other study ID #: 06/04/26/5.01
• Status: Unknown status
• Phase: N/A
• First received: September 5, 2008
• Last updated: February 5, 2010
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: August 2009
• Source: John Hunter Children's Hospital
• Contact: Donald Anderson, FRACP
• Phone: 61-2-49855634
• Email: donald.anderson[@]hnehealth.nsw.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age 11 - 18 years old

• Currently using indvidual subcutaneous injections (not CSII)

Exclusion Criteria:

• HbA1c > 9.5%

• Serious illness

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• 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:
• 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

Locations

Country	Name	City	State
Australia	Mater Children's Hospital	Brisbane	Queensland
Australia	Royal Children's Hospital	Brisbane	Queensland
Australia	Gosford District Hospital	Gosford	New South Wales
Australia	John Hunter Children's Hospital	Newcastle	New South Wales
Australia	Sydney Children's Hospital	Sydney	New South Wales

Sponsors (6)

Lead Sponsor	Collaborator
John Hunter Children's Hospital	Lady Cilento Children's Hospital, Brisbane, NovoNordisk Pharmaceuticals, Royal Children's Hospital, Royal North Shore Hospital, Sydney Children's Hospitals Network

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours BGL > 8.3mmol/l (CGMS)		3 months
Secondary	HbA1c		3 months