What would it cost to license or integrate this technology?+
The project was coordinated by TNO, a major Dutch applied research organization, with 3 SMEs in the consortium. Licensing terms would need to be negotiated directly with the consortium. Based on available project data, no specific pricing model is published, but the mix of research and industry partners suggests technology transfer pathways exist.
Can this scale to handle large patient populations?+
The system uses a cloud-based Data Integration Service designed to collect and process data from personal devices and EHR/PHR systems in real time. It was validated across 3 country trials (NL, DE, ES), demonstrating cross-border scalability. The architecture with 55 deliverables covering data processing, recommender engines, and GUI components suggests enterprise-grade design.
What is the IP situation and who owns the technology?+
IP is shared among 8 consortium partners across 6 countries (AT, DE, ES, FR, NL, TR). TNO as coordinator likely holds key patents on the predictive models. Specific IP arrangements would follow Horizon 2020 grant agreement rules, where each partner typically owns the IP they generated.
Does this comply with medical device regulations?+
The system completed randomised clinical trials in 3 countries, which is a strong foundation for regulatory approval. However, as a Horizon 2020 research project, full CE marking or FDA clearance would still require additional regulatory steps. The clinical trial evidence significantly de-risks the regulatory pathway.
How long would it take to integrate this into an existing platform?+
The project produced multiple prototype releases and an integrated system with both web-based and mobile GUI components. The modular architecture — separate predictive engine, recommender engine, action plan engine, and data processing layer — allows partial integration. Based on the 55 deliverables produced, substantial technical documentation exists to support integration.
What clinical evidence supports this system?+
The project completed a full randomised trial campaign (D5.4.3) with field trials in the Netherlands, Germany, and Spain. Three successive prototype releases were tested with real T1 and T2 diabetes patients. This level of clinical validation is unusually strong for an EU research project.
What patient data does the system need to work?+
The system processes data from personal monitoring devices (glucose meters, wearables) and electronic health records (EHR/PHR) in real time through its cloud-based Data Integration Service. It combines this with predictive models for plasma glucose, disease progression, and complication risk scoring. Data privacy compliance would follow GDPR standards given the EU consortium.
