Individualisation in diabetes therapy
The number of Type 1 diabetics using old insulin pumps without secure communication interfaces to build their own “Closed Loop” system is growing steadily. The so-called “loopers” are thus sending a clear signal to manufacturers and showing what is in demand for insulin pump therapy.
But what does “closed loop” actually mean? “Closed Loop” systems consist of an insulin pump, a sensor for continuous glucose measurement and an algorithm that automatically controls the insulin pump. All devices communicate via Bluetooth®. This means that the user can automatically control his insulin pump therapy to a certain extent without any intervention on his part.
Modularity creates added value for users
Meanwhile, the loopers are picking up momentum from international organisations. With its “Open-Protocol Automated Insulin Delivery (AID) Systems Initiative”, the globally active and renowned Juvenile Diabetes Research Foundation (JDRF) has created a framework to support manufacturers in the development of open systems. The aim is to create a legal and regulatory framework in which open and individualised systems can be approved officially. Until now, the loopers with their selfmade systems have acted on their own responsibility.
Our attention is clearly focused on the different needs of the users of our products. True to our vision of “a free choice in pump therapy”, we therefore design and develop our products on a modular basis, i.e. not as a closed system, but also for people who feel responsible for their own therapy. For this reason we have also decided join the initiative of the JDRF.
Over two years, JDRF will provide funding to accelerate the development of the next generation of the mylife™ YpsoPump®, which will enable even better automated insulin delivery by exchanging data over open communication protocols with smartphone apps and devices. This development enables a seamless connection with the mylife™ YpsoPump® via secure, well documented and verified communication protocols. Together with partners such as JDRF and other international research institutions, we are convinced that we can create an open platform that will enable even more individualised insulin pump therapy. Our objective is to support this interoperability so that users can choose the most appropriate solution for their therapy needs. From simple handling without combination with a continuous glucose sensor to individually optimised and highly automated solutions.
Clinical trials and new approval processes
For the further development of our mylife™ YpsoPump® and the establishment of our open pump concept, we will now place our insulin pump in clinical trials in various countries. Our aim is to further demonstrate the added value of individualised therapy with open insulin pumps and to drive the development of open systems forward. In addition to a pilot study in collaboration with Professor Cohen of the renowned Baker Institute in Australia, studies are planned in Germany, France, Italy and Switzerland.
We are not the only ones to respond to the requirements of the loopers. The regulatory authorities have also recognised that new approval processes are required for open and individualised systems. The U.S. health authority FDA is now offering the ACE approval process. ACE stands for “Alternate Controller Enabled” and means that not only closed insulin pump systems, but also individual open system components can be approved for insulin pump therapy in the future. This not only offers manufacturers such as ourselves more flexibility in the development of insulin pump systems in the medium and long term, but above all, it gives users more freedom in their choice of therapy.
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