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Bolus Insulin Card Calculator Randomised Controlled Study

NCT00748137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-02-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Royal North Shore Hospital

    collaborator OTHER

  • Sydney Children's Hospitals Network

    collaborator OTHER

  • Royal Children's Hospital

    collaborator OTHER

  • Lady Cilento Children's Hospital, Brisbane

    collaborator OTHER

  • NovoNordisk Pharmaceuticals

    collaborator UNKNOWN

  • John Hunter Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-10-31
Completion
2011-01-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748137 on ClinicalTrials.gov