The EU-funded project "KidsAP" is working on an artificial pancreas to fundamentally change the treatment of type 1 diabetes in children between one and seven years of age.
According to Dr. Thomas Kapellen, from the Leipzig University Hospital (in German: Universitätsklinikum Leipzig or UKL), the results now published in the specialist journals Pediatric Diabetes and Diabetes Care could help to facilitate and improve the lives of very young people with diabetes and those who care for them. A major follow-up study will start in the autumn of 2019.
Dr. Kapellen monitors the health of some 400 children and adolescents with diabetes at the UKL. Most of them use an insulin pump, and a smaller number the "pen". "Diabetes technology has evolved," he says, "modern insulin pumps today communicate wirelessly with sensors located in subcutaneous fatty tissue, where they continuously measure glucose." Using these sensor data, the latest generation of devices can make decisions to prevent hypoglycemia and, for example, reduce the insulin dose.
The artificial pancreas goes one step further in diabetes care. It can be described as a portable medical system that uses digital technology to automatically administer insulin. The third component to be added to the pump and sensor is a smartphone with a special app. It contains an algorithm that uses the sensor data to calculate the insulin dose, controls the pump and can, therefore, reduce or increase the basal rate, i.e. the basic insulin requirement.
This three-component setting is defined as a "hybrid closed-loop" system, from which diabetologists like Dr. Kapellen expect huge benefits. "During rest periods, during the night and between meals, the system works completely autonomously", explains the UKL expert. He adds: "only at mealtimes must the user himself become active, hence the 'hybrid' part".
"For the first time, this type of system has now been tested within such a young age group," Dr. Kapellen emphasizes. Children at this age have a very low insulin requirement, and there are also enormously high safety requirements due to the low age of the study participants. The pilot study, led by Prof. Roman Hovorka from the University of Cambridge, was focused on finding out whether insulin had to be diluted for the use of the artificial pancreas in very young children.
For this purpose, 24 girls and boys aged between 18 months and 7 years were recruited in Great Britain, Luxembourg, Austria and at the UKL, Germany. Using the "closed-loop" system, they received diluted insulin for three weeks and standard insulin for three weeks. The result: There are no differences. Children who used the artificial pancreas do not need diluted insulin. And this is a big advantage because insulin can be monitored more safely and easily with standard strength. This finding was an important preliminary result for the follow-up study.
Parents and carers of sick children would also benefit greatly from such a system, as under current treatments they have to check their sugar levels several times during the night, for example. "The parents of the 24 test participants in our pilot study trusted the system," reports Dr. Kapellen, adding that "they slept better and did not have to get up all the time”. According to the diabetologist, the insulin requirement of children in the age group studied also changes from hour to hour. The system is also ideal for this fluctuation, as it can adapt to it no matter where the children are at any given time.
The second, larger and also EU-funded KidsAP follow-up study with 84 children and a duration of one year has already started in Cambridge, UK. The UKL will also host a study in the autumn of 2019. "We have many interested patients," says Dr. Kapellen, "and all the parents from the pilot study want to participate again.”