The overall strategy of PCDIAB is
- to create a portable bihormonal AP system
- to develop a single-port AP prototype including glucagon delivery.
The division of the work in objectives and work packages follows this PCDIAB strategy.
WP 1 “Project management” will address project coordination and management. It will foster collaboration between the partners, monitor progress and ensure compliance with EC requirements.
WP 2 “Development of a portable artificial pancreas, CGM performance alert and exercise detection” will be developing the portable artificial pancreas. The steps towards a portable device contain embedding software in a small wearable device, wireless connectivity and adapting the current hardware to a small wearable device. Also an online CGM performance alert will be developed and evaluated. This alert will warn the future users if the CGM technically fails and would be a real innovation in the closed loop performance and an important safety tool in daily life. Finally exercise detection by heart rate monitoring will be further developed to improve the algorithm.
WP 3 “Home testing validation and acceptance of the portable artificial pancreas” will validate the portable artificial pancreas at home, in daily life. This will consist of pilot trials to test feasibility and efficacy and of performing a larger randomized clinical trial in different European countries. Also patient acceptance of the artificial pancreas will be measured by the artificial pancreas acceptance questionnaire. This questionnaire has been developed by one of the partners of the consortium.
WP 4 “Interaction between glucagon administration and continuous glucose monitoring” will examine local interaction between subcutaneous glucagon administration and performance of the CGM. In animal models and type 1 diabetes patients, interaction between glucagon administration and GCM readings will be studied to allow the development of a one needle system in the future.
WP 5 “Glucagon Pharmacology” will investigate the dose-response relationship and possible tachyphylaxis of glucagon.
WP 6 encompasses the various activities focused on information, communication, dissemination, stakeholder involvement, use of project results, business development and standardization.