January 2020: update
Nearly at the end of 2019, the Sytske Foundation looks back on an eventful but successful year and looks forward to 2020 with excitement.
The Sytske Foundation attends a quarterly meeting organized by the developer of the pump, IPaDIC. At this meeting IPaDIC informs its participants about the latest state of affairs.
IPaDIC reports that the money the Sytske Foundation was able to transfer to IPaDIC, thanks to your donations, to finance the development of the updated prototype version of the internal implantable insulin pump DiaLin has been well spent. They report also that the prototype of the pump is now available. The tests that have been done so far have yielded lessons, but they do not stand in the way of further development. The materials and functionalities used have been extensively tested. These meet the strictest requirements under national and international legislation. We work according to the new MDR (Medical Device Regulation) rules and there is already co-operation with a certified notified body (an inspection or testing institute designated by the government that must test whether products comply with the applicable (European) regulations).
In addition, IPaDIC reports that preclinical tests were started in the autumn of 2019, in which bench tests will check the effectiveness and safety of the product. After these tests, the prototype will be developed further. Taking into account any setbacks during this process, it is expected, according to IPaDIC, that the first clinical tests and treatments for current pump users will take place at the end of 2020. They will be the first ones allowed to use the new insulin pump and will receive intensive supervision during this phase.
Medtronic has made a single part of the current pump available to IPaDIC. With the development of the new insulin pump, the initiators will use a small part of Medtronic's technology. This is a process that must be done accurately and therefore takes longer. In addition, the safety checks and studies into effectiveness (such as filling and flushing the pump) also require a lot of time before a new pump can actually be made available.
Financing the next phases
IPaDIC is currently busy looking for sufficient financing for the development and production of the DiaLin pump.
As soon as there are any new developments, we will of course keep you informed via the website. For now we wish you a healthy 2020 on behalf of Sytske and the Sytske Foundation!
Board of Sytske Foundation
Advisory Board of Sytske Foundation