(Vienna, 20 February 2020) An international research project (KidsAP) in which Birgit Rami-Merhar and her team from MedUni Vienna's Department of Pediatrics and Adolescent Medicine are participating, is testing a new artificial pancreas system for young children up to primary school age. The children, who have (type 1) diabetes, will be given a "Closed-Loop System" consisting of a glucose sensor and an insulin pump, which is controlled via a smartphone app. The system has already been successfully tried and tested in adults and adolescents and the intention is now to simplify life for even younger patients.
In the recently launched multinational EU project “KidsAP" (€4.9 million project funding over three years), scientists are studying the use of a so-called "Closed-Loop System" (artificial pancreas). The system that is being studied was developed at the University of Cambridge to control blood glucose levels in young children (aged between 1 and 7 years). The main study for the international research project has now started at the Medical University of Vienna (Department of Pediatrics and Adolescent Medicine) together with the medical universities of Innsbruck and Graz, the universities of Leipzig, Luxembourg, Cambridge, Leeds Teaching Hospital and the University of Edinburgh.
Closed-Loop System: mobile glycaemic control for better quality-of-life
Over the course of the past few years, there have been significant advances in the treatment of patients with type 1 diabetes. New glucose sensors and insulin pumps greatly simplify the management of diabetes. An artificial pancreas or "Closed-Loop System" combines a body-worn insulin pump with a glucose sensor. The quantity of insulin that is delivered is regulated by a control algorithm. Based on continuous glucose measurement, the quantity of insulin required at any particular time is automatically calculated and automatically delivered by the pump, thereby taking over the function of the human pancreas.
The system being tested in the KidsAP project comprises a glucose sensor, an insulin pump and a smartphone. The key element is the app, which was developed at the University of Cambridge and is installed on the smartphone. Based on the glucose levels measured and transmitted by the glucose sensor, this app calculates the optimum amount of insulin required to maintain glucose levels within an optimum range.
It is particularly very young and preschool children who would derive the most benefit from this artificial pancreas, since they have significant variations in blood glucose levels, coupled with a very small insulin requirement.
A first commercial system, the Medtronic 670G system, has recently become available in Austria following approval by the Food and Drug Administration (FDA) in the USA and approval by the European authorities. However, it is initially envisaged that this system will only be used for adults and adolescents and children over the age of seven. Approval studies by other research groups and manufacturers are currently underway or in the planning stage. In contrast to the commercially available system, the study system allows individual blood glucose target ranges to be defined and necessitates far fewer blood glucose measurements on a finger.
System simplifies everyday insulin management in young children
The pilot study for the KidsAP project started in the summer of 2017 and has now been successfully completed. The children wore the trial system for a total of six weeks within the domestic setting. "In addition to the advantages of good glucose control, the parents reported beneficial everyday effects, especially more stable and therefore more restful nights, both for the young children and their parents, because they no longer needed to get up regularly during the night to monitor their child’s blood sugar," said the scientists, describing the advantages of the system (published in "Diabetes Care").
The second study in the EU project has now just started. The children will wear the "Closed-Loop System" for four months at home under normal routine conditions. The aim is to check for safety, reduced blood glucose variations, improvement in long-term glucose values (HbA1c), and usability (user acceptance and equipment operating life) during this period and record data relating to quality-of-life. The study coordinator at MedUni Vienna is Birgit Rami-Merhar from the Department of Pediatrics and Adolescent Medicine of MedUni Vienna/Vienna General Hospital.
Around 650,000 people in Austria suffer from diabetes, 26,000 of these from type 1 diabetes. There are even approximately 1,500 children (under the age of 14) with diabetes, primarily type 1 diabetes, in which there is an insulin deficiency. The Diabetes Out-Patient Clinic at the Department of Pediatrics and Adolescent Medicine of MedUni Vienna/Vienna General Hospital looks after around 400 children and adolescents with diabetes.