An essential aspect of MELISSA is the clinical study that validates the newly developed platform directly with patients under medical supervision and guidance.
The study will take place at five clinical sites in four European countries, namely The Netherlands, Denmark, Germany and Greece. The randomised controlled clinical trial will include 450 people with diabetes on multiple dose insulin, both with diabetes type 1 and type 2, to be performed in a parallel group design with a total duration of 18 weeks.
Today, there is no AI-powered application that was able to get the authorisation for clinical validation. MELISSA aims to set a precedent to get the green light for clinical validation and subsequently seek approval by the national regulatory authorities of the European countries for widespread clinical use.
The process of the multi-centre clinical validation study: