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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12608000189325 |
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Date of registration:
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11/04/2008 |
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Primary sponsor: |
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Public title:
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Does starting children on an insulin pump improve how blood vessels work due to less variable blood glucose levels?
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Scientific title:
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Does commencing a continuous subcutaneous insulin infusion reduce glucose variability and improve vascular function in children with type 1 diabetes. |
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Date of first enrolment:
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18/04/2008 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12608000189325.aspx |
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Study type:
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Interventional |
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Study design:
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Nonrandomised trial
Crossover |
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Jennifer Harrington |
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Address:
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72 King William Road
North Adelaide SA 5006, Australia
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Telephone:
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08 8161402 |
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Email:
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jennifer.harrington@cywhs.sa.gov.au |
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Affiliation:
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Name:
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Dr Jennifer Harrington |
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Address:
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72 King William Road
North Adelaide SA 5006, Australia
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Telephone:
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08 81616402 |
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Email:
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jennifer.harrington@cywhs.sa.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: smoking, history of allergic reaction to nitrates or nitrites, pregnancy
Age minimum:
8 Years
Age maximum:
18 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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cardiovascular disease
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type I diabetes
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Intervention(s)
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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
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Primary Outcome(s)
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Glucose variability. Glucose variability will be assessed by using a Medtronic Minimed Paradigm Real-Time continuous glucose monitoring system (CGMS).
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Vascular function. Vascular endothelial function will be assessed using flow-mediated dilatation (FMD).
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Secondary Outcome(s)
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vascular risk factors - venous blood test for : HbA1c, fasting lipids and glucose, hsCRP, adiponectin
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Source(s) of Monetary Support
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Pfizer Australia Paediatric Endocrine Care Grant
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Adelaide Children, Youth and Women's Health Service
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