Late stage development and preparation of a long-term non-enzymatic continuous glucose sensor for clinical trials

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Abstract Diabetes is a complex multi-factorial disease that diminishes the length and quality of life of affected individuals. The use of continuous glucose monitors (CGM) can be an invaluable management tool for patients afflicted by this chronic and costly disease. However, despite years of development, currently available continuous glucose monitors (CGMs) still lack good accuracy and reliability for short-term and particularly, long-term use in diabetes management. The main obstacles to achieving a long-term, accurate CGM are instabilities in the sensing chemistry and the body’s immune response against the sensor – specifically the foreign body response (FBR) – leading to biofouling, inflammation, avascular fibrosis and sensing chemistry degradation. Additionally, current CGM systems in the market and under development are either bulky percutaneous probes or implantable devices encased in hard metals or plastics that become surrounded by an avascular tissue capsule over time or are taken up by immune cells (if nano-sized). Profusa has developed fluorescent, non-enzymatic boronic acid (BA)-based glucose sensors that are produced in a tissue-integrating hydrogel format that has been shown to minimize the FBR, enabling long-term monitoring. In this CRP SBIR, we aim to guide our successfully demonstrated injectable glucose sensors through late stage development and technical activities that are vital for commercialization. Clinical translation of this technology will motivate and enable diabetic and pre-diabetic patients to more tightly control their glucose levels without fear of hypoglycemia and will reduce the diabetes disease burden on the healthcare system. In this project, we propose to prepare the path for first-in-human clinical testing, as a first step towards commercialization. To this end, we will demonstrate production of sterile, biocompatible, packaged sensors ready for clinical trial use in order to ensure compliance with regulatory standards. We will perform market research analysis to determine target population, assess reimbursement potential, and develop regulatory strategies to align clinical development with business objectives. In addition, we will complete documentation regarding investigational device exemption. Finally, we will design and plan for a first-in-human (FIH) clinical trial by preparing all necessary documents for IRB submission. This proposal will aid Profusa in moving its glucose sensor towards commercialization, to significantly improve the health and quality of life of pre-diabetic and diabetic patients.