A randomized controlled trial comparing the impact of continuous subcutaneous insulin infusion (CSII) therapy and multiple daily injection (MDI) regimens upon indices of behaviour, cognition and glycaemia in children and adolescents with type 1 diabetes.

The Royal Children's Hospital Melbourne0 个研究点目标入组 110 人开始时间: 2010年7月26日最近更新: 2021年11月15日

适应症

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•Youth aged 9-15.5 years with type 1 diabetes mellitus. Most children younger than 9 are unable or unwilling to use an MDI regimen, as this involves a lunchtime injection of insulin at school, which can be practically difficult for young children. Sixteen is the older end of the validated age range for the selected cognitive tests employed; therefore adolescents recruited at 15.5y will still be <16y at the end of study.
•Naïve to CSII therapy
•Currently using MDI regimen for at least 1 month duration
•Previously assessed as suitable for CSII (by their own diabetes physician and care team) and already on the waiting list to commence CSII at their institution. This inclusion criterion is necessary as not all youth will be willing or deemed suitable to commence CSII (e.g. if not performing self monitoring of blood glucose levels at least 4 times / day).
•Have access to an insulin pump device through private health insurance, self-pay or local loan scheme

•Non-English speaking (as behavioural questionnaires and cognitive tests are conducted in English)
•Co-existent developmental delay or pervasive neurological disorders such as autism that would interfere with a participant’s ability to perform psychometric testing

发起方

The Royal Children's Hospital Melbourne