Members of the Hovorka Group teamed with an international team of researchers have compared the performance, in children, of the artificial pancreas against ‘sensor-augmented pump therapy’. The artificial pancreas uses an algorithm run by a mobile phone app (CamAPS FX) to automate delivery of insulin according to need. They found that it is both safe to use and more effective at managing their blood sugar levels than current technology. The research is published today in the New England Journal of Medicine.

CamAPS FX has been shown to work in older children and adolescents with type 1 diabetes. Today’s study is the first time that it has been shown to be effective over several months in very young children. Management of type 1 diabetes is challenging in very young children for several reasons including high variability in levels of insulin required and unpredictable eating and activity patterns. Children are particularly at risk of dangerously low and high blood sugar levels, which can lead to adverse outcomes.

Current technology – sensor-augmented pump therapy – requires parents to review their child’s glucose levels using a monitor and then manually adjust the amount of insulin administered by the pump. These devices have proved successful to an extent in older children, but not in very young children.

Professor Roman Hovorka explained

CamAPS FX makes predictions about what it thinks is likely to happen next based on past experience. It learns how much insulin the child needs per day and how this changes at different times of the day. It then uses this to adjust insulin levels to help achieve ideal blood sugar levels. Other than at mealtimes, it is fully automated, so parents do not need to continually monitor their child’s blood sugar levels.

On average, children spent around three-quarters of their day (71.6%) in the target range for their glucose levels when using CamAPS FX – an additional 125 minutes per day in the target range compared to those using the currently available approach.

Dr Julia Ware, the study’s first author, said

Very young children are extremely vulnerable to changes in their blood sugar levels. High levels in particular can have potentially lasting consequences to their brain development. On top of that, diabetes is very challenging to manage in this age group, creating a huge burden for families.

CamAPS FX led to improvements in several measures, including hyperglycaemia and average blood sugar levels, without increasing the risk of hypos. This is likely to have important benefits for those children who use it.

Parents involved in the study have described using the artificial pancreas as ‘life-changing’ as it meant they were able to relax and spend less time worrying about their child’s blood sugar levels, particularly at night time. Dr Ware said

They tell us it gives them more time to do what any ‘normal’ family can do, to play and do fun things with their children.

Professor Hovorka reflected on the development of the artificial pancreas

From the first clinical trials of our algorithms to today’s findings has taken well over a decade, but the dedication of my team and the support of all the children and families who have taken part in our studies, has paid off. We believe our artificial pancreas will transform the lives of families with very young children affected by type 1 diabetes.

A more detailed description of the research and its implications is available on the main Cambridge University website.

The research was funded by the European Union’s Horizon 2020 Framework Programme, with additional support from the NIHR Cambridge Biomedical Research Centre, and JDRF.