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.

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Studies have also shown that children with Type 1 diabetes mellitus (T1DM) have much higher rates of problems with behaviour and cognition (learning, understanding, attention, memory etc) which can affect their health and quality of life. In particular, youth who have more problems with behaviours such as aggression and conduct (called ‘externalising’ behaviours) have been shown to have much higher rates of poorer mental health outcomes and poor long-term diabetes control. It is known that despite having regular insulin injections, individuals with T1DM can have large swings in blood glucose levels (from very high to very low or vice versa) over the course of a day. These high and low levels of glucose not only give rise to uncomfortable symptoms, but have also been shown to result in an increase in externalising behaviours and impaired mental functioning. ‘Intensive insulin therapy’ regimens involve either multiple daily injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) using an insulin pump. These regimens aim to better mimic the work of the pancreas and therefore to reduce the large swings in glucose found in T1DM. A previous study that followed up 32 youth who commenced use of CSII showed significant improvements in their scores of behaviour & cognition after 6-8 wks. Improvements in behaviour have persisted to 2 years in those using CSII. Of note however, there was no control group in this pilot study and so results can not be generalised. If however, similar results were found when comparing CSII and MDI, then CSII would offer additional health and wellbeing benefits for youth with T1DM. The aim of this randomised controlled trial is to assess whether, in a group of youth already using MDI, commencement and continued use of CSII results in improvements in indices of behaviour and cognition, and if so, whether these changes are as a result of improved glucose profiles. The study will run at both the Royal Children’s Hospital Melbourne (VIC) and the Children’s Hospital Westmead, (NSW). Children and adolescents aged 9-16 years who are on the waiting list to commence CSII (i.e willing to use CSII and assessed by the diabetes team as capable of doing so) will be invited to participate. Assessments performed will include standardised behaviour questionnaires and cognitive tests (supervised and scored by a trained psychologist) as well as 6 days of continuous glucose monitoring (using a probe inserted under the skin which continuously records glucose measurements) and HbA1c (a standard monitoring test of glucose control). Following baseline assessments, 110 youth will be randomly assigned to either continue MDI or to commence and continue CSII. All participants will then have standard diabetes care until assessments are repeated at the end of a 4month period. Differences between outcomes in the 2 study groups at 4 months will be compared. Between group difference in scores of externalising behaviour at 4 months is the primary outcome of interest. Differences in scores of mood, cognition and markers of glucose control at 4 months are secondary outcomes of interest. Since all participants will be recruited from the CSII waiting list, at the end of the 4 month study period, those randomised to continue MDI will be commenced on CSII.

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