The Inreda bi-hormonal blood glucose control pump: A beacon for high-risk diabetes patients, providing fully automated in disease management

Obiettivo

This proposal aims to finalize, validate, and commercialize a next-generation, fully automated artificial pancreas (AP) system that delivers both insulin and glucagon to people with type 1 diabetes (T1D). By eliminating complex meal announcements and managing both low and high glucose extremes, the AP significantly reduces the daily stress of diabetes management. This approach directly addresses the tens of thousands of T1D patients who struggle to maintain stable glucose levels with existing insulin-only therapies or partial closed-loop solutions.
We will achieve this goal through a structured series of work packages. First, we will refine the AP6 device’s algorithms, hardware, and sensor technology, ensuring that the system is safe, durable, and user-friendly for real-world use. Next, we will obtain broad regulatory approvals in Europe under MDR Class III, supported by large-scale clinical reimbursement trials to confirm both the system’s clinical effectiveness and cost savings for healthcare payers. In parallel, our manufacturing facility will be expanded to meet the demands of international markets, with distribution pathways established in key European regions before moving toward FDA clearance for the United States. Throughout these steps, we will integrate remote monitoring and telehealth functionality, aligning the AP with emerging outpatient and home-based care models.
This proposal strongly aligns with the EIC work programme by delivering a pioneering device that tackles a major chronic disease and bolsters Europe’s MedTech leadership. Its dual-hormone system surpasses current standards, benefiting patients, providers, and insurers. It will likely reduce hospital visits, foster better patient outcomes, and produce major social and economic impact across Europe, fulfilling the EIC’s mission to back high-impact innovations that transform healthcare.