The aim of this project was the development of a wearable artificial pancreas that automatically regulates insulin delivery, enabling patients with diabetes to live a close to normal life. The EU-funded AP@home project has developed a prototype to reduce treatment burden in daily life in patients with diabetes. The next step is to develop this prototype system into a product. The AP@home project was funded through the 7th Framework Programme. It started in 2010 and has just come to an end. Universities and companies in Germany, UK, the Netherlands, France, Austria, Italy and Switzerland participated in the project (www.apathome.eu).
In order to improve treatment of diabetes patients using insulin, AP@home built and evaluated an artificial pancreas (AP) that works reliably day and night under at-home conditions.
"The AP we developed allows automated glucose control in patients with diabetes; it continuously monitors glucose (sugar) levels in the body and it includes a software algorithm that calculates how much insulin should be delivered at any given time via an insulin infusion pump", says Professor Dr. Lutz Heinemann, coordinator of the project. "Automating the delivery of insulin would greatly improve treatment outcome since blood glucose levels are very much affected by many factors such as diet, physical activity, illness and stress. That makes it difficult for patients to judge how much insulin they need. Taking the burden of diabetes therapy off the patients' shoulders will also greatly improve the quality of life of patients."
One major activity of the AP@home project was to develop an AP platform that establishes the communication between the commercially available continuous glucose monitor (CGM) and the insulin pump. The algorithms needed to calculate the appropriate infusion rates are a proprietary development of partners of the project. The software runs on a smartphone, which is an integral part of the AP platform.
At present two different versions of the AP platform are being evaluated in the home environment of patients in the framework of clinical studies. The patients use the AP system for up to three months at home without constant supervision by a physician, living their normal lives.
The development from the prototype developed in the AP@home project into a product will hopefully take place in the coming years in cooperation with a large manufacturer of medical devices. The product should simplify and optimize diabetes care. At the same time it should greatly improve the quality of life of patients with diabetes. It should also reduce the risk of diabetes related complications and diminish health costs in the long run.
In parallel, an innovative AP device was developed in the AP@home project that combines the insulin pump and the glucose sensor in one device. By using such a combined device the patients not only have to carry one device less with them; also the number of access points through the skin are reduced from two to one. This novel AP system is currently investigated at the patients’ home as well; however, currently only for some days and not for months.
At present an AP@home study is performed where the patients wear the artificial pancreas unsupervised day and night for 3 months in their home environment. The first interim analysis shows that under this free living conditions the artificial pancreas improves glucose control and reduces exposure to hypoglycaemia without increasing total daily insulin requirements in adults with type 1 diabetes. The patients are very pleased and one stated after the first week using the artificial pancreas: 'Great, my blood suger was never so well controlled and that without my own contribution'.