Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000189325
Ethics application status
Approved
Date submitted
9/04/2008
Date registered
11/04/2008
Date last updated
11/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Does starting children on an insulin pump improve how blood vessels work due to less variable blood glucose levels?
Scientific title
Does commencing a continuous subcutaneous insulin infusion reduce glucose variability and improve vascular function in children with type 1 diabetes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type I diabetes 3019 0
cardiovascular disease 3020 0
Condition category
Condition code
Metabolic and Endocrine 3168 3168 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
continuous subcutaneous insulin infusion (insulin pump), dose at calculated based on normal insulin requirements, study to continue for 3 weeks but patients to continue on insulin pump after study is complete
Intervention code [1] 2760 0
Treatment: Devices
Comparator / control treatment
Comparator will be the patient's normal subcutaneous insulin regimen prior to commencing on the insulin pump. Insulin dose and number of injections will be dependent on the need of the individual.
Control group
Active

Outcomes
Primary outcome [1] 4051 0
Glucose variability. Glucose variability will be assessed by using a Medtronic Minimed Paradigm Real-Time continuous glucose monitoring system (CGMS).
Timepoint [1] 4051 0
just prior and then 3 weeks after commencing an insulin pump
Primary outcome [2] 4052 0
Vascular function. Vascular endothelial function will be assessed using flow-mediated dilatation (FMD).
Timepoint [2] 4052 0
Just prior and then 3 weeks after commencing an insulin pump
Secondary outcome [1] 6825 0
vascular risk factors - venous blood test for : HbA1c, fasting lipids and glucose, hsCRP, adiponectin
Timepoint [1] 6825 0
just prior and then 3 weeks after commencing an insulin pump

Eligibility
Key inclusion criteria
Children with type I diabetes from the diabetes clinic at the Adelaide Chidren, Youth and Women's Health Service on the waiting list to commence an insulin pump
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
smoking, history of allergic reaction to nitrates or nitrites, pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Subjects will have glucose variability and vascular function assessed prior and then 3 weeks after commencing an insulin pump
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3275 0
Hospital
Name [1] 3275 0
Adelaide Children, Youth and Women's Health Service
Country [1] 3275 0
Australia
Funding source category [2] 3277 0
Other Collaborative groups
Name [2] 3277 0
Pfizer Australia Paediatric Endocrine Care Grant
Country [2] 3277 0
Australia
Primary sponsor type
Hospital
Name
Adelaide Children, Youth abd Women's Health Service
Address
72 King William Road
North Adelaide
Country
Australia
Secondary sponsor category [1] 2929 0
Other Collaborative groups
Name [1] 2929 0
Pfizer Australia Paediatric Endocrine Care Grant
Address [1] 2929 0
APEC Research Grants
PO BOX 57
Country [1] 2929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5264 0
Adelaide Children, Youth and Women's Health Service Research Ethics Committee
Ethics committee address [1] 5264 0
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 5264 0
Australia
Date submitted for ethics approval [1] 5264 0
Approval date [1] 5264 0
02/04/2008
Ethics approval number [1] 5264 0
REC2032/2/11

Summary
Brief summary
We already know that blood glucose levels relate to the long term vascular complications in type I diabetes. There have been other studies that suggest that blood glucose variability (i.e. how much the blood glucose levels vary through the day) may also be an important factor. The purpose of this study is to look at blood vessel function and glucose variability in children whilst they are on insulin injections compared with shortly after starting an insulin pump.
The hypotheses to be tested are:
•Commencing children with type I diabetes on a insulin pump improves how blood vessels work
•Commencing children with type I diabetes on a insulin pump reduces glucose variability
•The improvement in how the blood vessels is due to reduced glucose variability independent of other changes in vascular risk factors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28507 0
Address 28507 0
Country 28507 0
Phone 28507 0
Fax 28507 0
Email 28507 0
Contact person for public queries
Name 11664 0
Dr Jennifer Harrington
Address 11664 0
72 King William Road
North Adelaide SA 5006
Country 11664 0
Australia
Phone 11664 0
08 81616402
Fax 11664 0
08 81617759
Email 11664 0
[email protected]
Contact person for scientific queries
Name 2592 0
Dr Jennifer Harrington
Address 2592 0
72 King William Road
North Adelaide SA 5006
Country 2592 0
Australia
Phone 2592 0
08 8161402
Fax 2592 0
08 81617759
Email 2592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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