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Bolus Insulin Card Calculator Randomised Controlled Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by John Hunter Children's Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Royal North Shore Hospital
Sydney Children's Network
Royal Children's Hospital
Lady Cilento Children's Hospital, Brisbane
NovoNordisk Pharmaceuticals
Information provided by:
John Hunter Children's Hospital
ClinicalTrials.gov Identifier:
NCT00748137
First received: September 5, 2008
Last updated: February 5, 2010
Last verified: August 2009
  Purpose
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.

Condition Intervention
Type 1 Diabetes
Device: ezy-BICC dose calculation card
Other: Fixed dose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bolus Insulin Card Calculator Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by John Hunter Children's Hospital:

Primary Outcome Measures:
  • 24 hours BGL > 8.3mmol/l (CGMS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fixed dose
Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin.
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
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.
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

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 11 - 18 years old
  • Currently using indvidual subcutaneous injections (not CSII)

Exclusion Criteria:

  • HbA1c > 9.5%
  • Serious illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748137

Locations
Australia, New South Wales
Gosford District Hospital
Gosford, New South Wales, Australia, 2915
John Hunter Children's Hospital
Newcastle, New South Wales, Australia, 2305
Sydney Children's Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Mater Children's Hospital
Brisbane, Queensland, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Sponsors and Collaborators
John Hunter Children's Hospital
Royal North Shore Hospital
Sydney Children's Network
Royal Children's Hospital
Lady Cilento Children's Hospital, Brisbane
NovoNordisk Pharmaceuticals
  More Information

Responsible Party: Dr Donald Anderson, Staff Specialist, John HUnter Children's Hospital
ClinicalTrials.gov Identifier: NCT00748137     History of Changes
Other Study ID Numbers: 06/04/26/5.01 
Study First Received: September 5, 2008
Last Updated: February 5, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by John Hunter Children's Hospital:
Type 1 Diabetes
Youth
Insulin dose

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 05, 2016