Bolus Insulin Card Calculator Randomised Controlled Study

NCT ID: NCT00748137

Last Updated: 2010-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fixed dose

Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin.

Group Type ACTIVE_COMPARATOR

Fixed dose

Intervention Type OTHER

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

ezy-BICC dose calculation card

variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin.

Group Type EXPERIMENTAL

ezy-BICC dose calculation card

Intervention Type DEVICE

small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject

Interventions

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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

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* HbA1c \> 9.5%
* Serious illness
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal North Shore Hospital

OTHER

Sponsor Role collaborator

Sydney Children's Hospitals Network

OTHER

Sponsor Role collaborator

Royal Children's Hospital

OTHER

Sponsor Role collaborator

Lady Cilento Children's Hospital, Brisbane

OTHER

Sponsor Role collaborator

NovoNordisk Pharmaceuticals

UNKNOWN

Sponsor Role collaborator

John Hunter Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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John HUnter Children's Hospital

Locations

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Gosford District Hospital

Gosford, New South Wales, Australia

Site Status RECRUITING

John Hunter Children's Hospital

Newcastle, New South Wales, Australia

Site Status RECRUITING

Sydney Children's Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Mater Children's Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING

Royal Children's Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Donald Anderson, FRACP

Role: CONTACT

61-2-49855634

Elizabeth Nunn, BSc

Role: CONTACT

61-2-49855634

Facility Contacts

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Donald Anderson, MBBS FRACP

Role: primary

+61 2 49855634

Liz Nunn, BHSc

Role: backup

61 2 49213753

Other Identifiers

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06/04/26/5.01

Identifier Type: -

Identifier Source: org_study_id

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