Bolus Insulin Card Calculator Randomised Controlled Study

February 5, 2010 updated by: John Hunter Children's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2915
        • Recruiting
        • Gosford District Hospital
        • Principal Investigator:
          • Monique Stone, MD
      • Newcastle, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Donald G Anderson, MBBS FRACP Grad Dip Biostat
        • Sub-Investigator:
          • Elizabeth Nunn, BHSc Grad Dip Epid
        • Sub-Investigator:
          • Dierdre Burgess, BSc
      • Sydney, New South Wales, Australia
        • Recruiting
        • Sydney Children's Hospital
        • Principal Investigator:
          • Charles Verge, MD
    • Queensland
      • Brisbane, Queensland, Australia
        • Recruiting
        • Mater Children's Hospital
        • Sub-Investigator:
          • Bridgid Knight
      • Brisbane, Queensland, Australia
        • Recruiting
        • Royal Children's Hospital
        • Principal Investigator:
          • Sarah MacMahon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • HbA1c > 9.5%
  • Serious illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hours BGL > 8.3mmol/l (CGMS)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Hunter Children's Hospital

Collaborators

Sydney Children's Hospitals Network
Royal Children's Hospital
Royal North Shore Hospital
Lady Cilento Children's Hospital, Brisbane
NovoNordisk Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

October 1, 2010

Study Completion (ANTICIPATED)

January 1, 2011

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (ESTIMATE)

September 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 5, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/04/26/5.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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