MedicalResearch.com Interview with:
Dr Julia Ware
(née Fuchs)
Clinical Research Associate
Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories
and Medical Research Council Metabolic Diseases Unit, University of Cambridge
Addenbrooke’s Hospital, Cambridge
MedicalResearch.com: What is the background for this study?
Response: Management of type 1 diabetes is challenging in very young children, due to their high variability of insulin requirements and unpredictable eating and activity patterns. As a result, many young children do not meet the recommended glycemic targets, or only maintain recommended glycemic control with extensive caregiver input. This in turn leads to high management burden and reduced quality of life for the whole family.
While the increasing use of continuous glucose-monitoring devices and insulin-pump therapy has led to reductions in the incidence of severe hypoglycaemia and diabetic ketoacidosis, and has been accompanied by modest improvements in glycemic control, the burden of management has remained high. Hybrid closed-loop systems (also called an artificial pancreas), in which an algorithm automatically adjusts insulin delivery on the basis of real-time sensor glucose levels, may address ongoing challenges in this age group. However, to date hybrid closed-loop studies involving very young children have been small and of short duration and the efficacy and safety of longer term use of a closed-loop system, as compared with standard therapy, was unclear.
To address this knowledge gap, we compared 16-week use of the Cambridge closed-loop algorithm with sensor-augmented pump therapy in children aged 1 to 7 years with type 1 diabetes in a multi-national randomised crossover study.
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