OBU is the project coordinator and is also responsible for the human factors and ergonomics. This includes designing a usability engineering process that adheres to international standards such as IEC 62366. The process involves users at every stage to ensure that it meets their needs. The evaluation uses multiple techniques to maximise usability, minimise errors and increase acceptance.
Imperial College London (ICL) embodies and delivers world-class scholarship, education and research in science, engineering, medicine and business, with particular regard to their application in industry, commerce and healthcare. It fosters interdisciplinary working internally and collaborates widely externally. Imperial has a reputation for excellence in teaching and research, consistently rated amongst the world's best universities. ICL is responsible for developing a safety system (Work Package 4) which guarantees patient�s safety while using the PEPPER system. To accomplish such task, the safety system includes: a dynamic insulin constraint, predictive glucose alarms, a predictive low-glucose insulin suspension module, a fault detection module and a carbohydrate recommender. ICL is also heavily involved in the execution of the clinical trials (Work Package 7) as clinical partner.
UdG lead the definition, design and development of the insulin recommender system based on case-based reasoning. This includes the instantiation of the different steps of the case-based reasoning methodology and their implementation both in the server and the client side of the platform, as well as with integration with the safety system.
IDIBGI lead the clinical validation of the PEPPER system. This includes the writing of the clinical protocols for obtaining regulatory and ethical approval for the 2 clinical trials proposed in the project from regulatory agencies and ethics committees of the two involved countries (UK, Spain); the recruitment and enrolment of the subjects to take part in the clinical trials; the execution of the trials and the evaluation of the clinical results. Two clinical trials will be performed: a feasibility study to test safety, technical proof of concept and feasibility of the PEPPER system (the decision support system and the safety algorithms) and to evaluate usability of the PEPPER handsets over a sustained time period; and a randomised crossover ambulatory clinical study to evaluate safety, feasibility and usability of the PEPPER system compared to a standard bolus calculator.
RomSoft builds the web application for the Pepper system. The application reads patient data from central database, implements the user interface for clinicians and patients and integrates the validation phase of the case-based reasoning system.
