Type 1 diabetes develops in childhood, requiring constant - often painful - management from the start. EU-funded researchers are testing an artificial pancreas that could transform the quality of life of youngsters suffering from the disease.
The wearable device combines a glucose sensor, an insulin pump and a mobile phone with an Android app that automatically matches the insulin supply to a child’s glucose levels.
A pilot study in Austria, Germany, Luxembourg and the UK has shown that the device can regulate children’s blood glucose more like a natural pancreas than can current diabetes treatments. Participating children had very few glucose highs or lows and needed no corrective insulin injections or additional distressing finger-prick blood tests.
The study is the first stage of the EU-funded KIDSAP project to demonstrate to health providers and insurers that the device is safe, effective and possible to use with young children, says the project coordinator, Prof Roman Hovorka, of the University of Cambridge in the United Kingdom.
‘This type of system has not been tried before in such a young population. It could really change the landscape of treatment of young children with type 1 diabetes,’ he adds.
Relief for families
‘Type 1 diabetes is a huge burden on families,’ Hovorka explains. It is an autoimmune condition that stops the pancreas from producing insulin to process glucose from food for energy. Untreated, the disease can lead to serious health problems or even death.
Although existing wearable insulin pumps supply the hormone at a fixed rate, young children’s blood glucose levels vary significantly according to what they eat, their activity levels and their health. Parents have to predict and correct extremes, including at night.
The artificial pancreas could help to relieve the burden. In the KIDSAP pilot study, 24 children with type 1 diabetes aged 18 months to 7 years tested the device at home for two periods of three weeks. ‘We had good feedback from the parents on the impacts on their children’s lives,’ says Hovorka.
The pilot study also helped researchers discover more about how doctors could use the device. It showed that there was no need to use diluted insulin for small children using the artificial pancreas. ‘This surprised us,’ Hovorka says, adding that standard strength insulin is safer and easier to monitor.
Patients were included in the study through eight universities and teaching hospitals from across the four study countries. Hovorka explains that this enabled researchers to eliminate impacts from differences in national diets and lifestyles and to assess how different healthcare systems will work with the device.
One issue was regulatory approval, especially as the device was being trialled in such young children. ‘It was a logistical challenge. We had to ask each country’s regulatory body and the different universities’ ethics committees for permission to use the device,’ says Hovorka.
Project members are sharing information about the project through the mass media and parents’ groups, as well as publishing KIDSAP results in scientific journals. In the UK, the national health system has publicised this project as one of the most important health research projects in the last 70 years.
The next step in the project is a larger study. This will involve up to 80 children aged 1 to 7 years with type 1 diabetes. Every child will use the artificial pancreas and a state-of-the-art standard insulin pump for four months each to compare their impacts on health, quality of life and cost effectiveness.
Along with the eight study partners, a non-profit research organisation and two SMEs are taking part in KIDSAP. ‘We have established a real consensus to take the research forward. Without the H2020 funding and collaboration network we could not do studies like this,’ Hovorka concludes.