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Bolus Insulin Card Calculator Randomised Controlled Study

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
ezy-BICC dose calculation card
Fixed dose
Sponsored by
John Hunter Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Youth, Insulin dose

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • HbA1c > 9.5%
  • Serious illness

Sites / Locations

  • Gosford District HospitalRecruiting
  • John Hunter Children's HospitalRecruiting
  • Sydney Children's HospitalRecruiting
  • Mater Children's HospitalRecruiting
  • Royal Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fixed dose

ezy-BICC dose calculation card

Arm Description

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

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

Outcomes

Primary Outcome Measures

24 hours BGL > 8.3mmol/l (CGMS)

Secondary Outcome Measures

HbA1c

Full Information

First Posted
September 5, 2008
Last Updated
February 5, 2010
Sponsor
John Hunter Children's Hospital
Collaborators
Royal North Shore Hospital, Sydney Children's Hospitals Network, Royal Children's Hospital, Lady Cilento Children's Hospital, Brisbane, NovoNordisk Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00748137
Brief Title
Bolus Insulin Card Calculator Randomised Controlled Study
Official Title
Bolus Insulin Card Calculator Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
John Hunter Children's Hospital
Collaborators
Royal North Shore Hospital, Sydney Children's Hospitals Network, Royal Children's Hospital, Lady Cilento Children's Hospital, Brisbane, NovoNordisk Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Youth, Insulin dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fixed dose
Arm Type
Active Comparator
Arm Description
Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin.
Arm Title
ezy-BICC dose calculation card
Arm Type
Experimental
Arm Description
variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin.
Intervention Type
Device
Intervention Name(s)
ezy-BICC dose calculation card
Intervention Description
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
Other
Intervention Name(s)
Fixed dose
Intervention Description
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
Primary Outcome Measure Information:
Title
24 hours BGL > 8.3mmol/l (CGMS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 11 - 18 years old Currently using indvidual subcutaneous injections (not CSII) Exclusion Criteria: HbA1c > 9.5% Serious illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donald Anderson, FRACP
Phone
61-2-49855634
Email
donald.anderson@hnehealth.nsw.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Nunn, BSc
Phone
61-2-49855634
Email
liz.nunn@hnehealth.nsw.gov.au
Facility Information:
Facility Name
Gosford District Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2915
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Stone, MD
Facility Name
John Hunter Children's Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Anderson, MBBS FRACP
Phone
+61 2 49855634
Email
donald.anderson@hnehealth.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Liz Nunn, BHSc
Phone
61 2 49213753
Email
liz.nunn@hnehealth.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Donald G Anderson, MBBS FRACP Grad Dip Biostat
First Name & Middle Initial & Last Name & Degree
Elizabeth Nunn, BHSc Grad Dip Epid
First Name & Middle Initial & Last Name & Degree
Dierdre Burgess, BSc
Facility Name
Sydney Children's Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Verge, MD
Facility Name
Mater Children's Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Harris, MD
First Name & Middle Initial & Last Name & Degree
Bridgid Knight
Facility Name
Royal Children's Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah MacMahon, MD

12. IPD Sharing Statement

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Bolus Insulin Card Calculator Randomised Controlled Study

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