The project will begin with a feasibility study to pilot the study set up and to address the specific needs of the studies population by comparing closed loop insulin delivery using standard strength insulin and diluted insulin. The results will feed into the design of the main study.
We hypothesise that diluted insulin will lead to more stable glucose levels by reducing inaccuracies accentuated by delivery of minute amounts of insulin (frequently less that 0.1U/h [1μl/h with standard strength insulin] in small children compared to 1U/h in adults). These inaccuracies may result from pump plunger micro-jumps, tissue pressure build-up, and infusion set kinking.
|Design||Open-label crossover multicenter randomised control trial (n=24 children from 7 sites)|
|Target Population||Children aged 1-7yrs with diagnosis of type 1 diabetes for at least 6 months, on insulin pump therapy for 3 or more months, willing to use continuous glucose monitoring and closed loop|
|Chief Investigator||Dr Roman Hovorka, University of Cambridge|
|Principal Investigators||Dr Carlo Acerini, Addenbrooke’s Hospital
Dr Carine de Beaufort, University of Luxembourg
Dr Fiona Campbell, St James’s University Hospital
Dr Elke Fröhlich-Reiterer, Medical University of Graz
Dr Sabine Hofer, Medical University of Innsbruck
Dr Thomas Kapellen, University of Leipzig
Dr Birgit Rami-Merhar, Medical University of Vienna
|We have now reached our recruitment target of 24 young children. Thank you to the families who agreed to take part.|