SBIR Phase I:Sentiomed Injectable 14-day Biodegradable Glucose Sensor System

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to commercialize a novel and affordable glucose monitoring system that measures glucose intermittently or continuously without wires, electronics, or physical attachments. The project system targets the 25million non-insulin dependent Type 2 Diabetics (NIDT2D), who do not measure their glucose levels daily or as recommended by their healthcare provider due to the inconvenience, embarrassment, and pain of fingersticks. NIDT2D in hospitals, long-term care facilities and those living in medically underserved areas could also benefit from this system. The system combines a biodegradable sensor that is injected once every two weeks and an external reader/transmitter, that when placed over the sensor, reads, and transmits the glucose level to a smart device. The data is stored and/or transmitted to caregivers and providers. The system enables the NIDT2D to measure their glucose often, even continuously, to better understand how diet and exercise affects their glucose levels.This Small Business Innovation Research (SBIR) Phase I project is the development of a biodegradable, biocompatible hydrogel sensor that can be self-injected beneath the skin surface. This sensor will be engineered to have a 14-day useful life before biodegrading into harmless components that are removed by the body’s natural processes. The hydrogels will be tuned to respond to different ultrasound frequencies so a newly injected hydrogel does not interfere with an old one that has not fully finished its decay cycle. Fabrication will be done with chemical components that have a long track record of successful use in the body. Specifically, an innovative process is employed to imbed phenyl boronic acid groups into a modified hyaluronic acid backbone. The hydrogel must also fit through a fine-bore needle without impairing its functionality. At least two approaches will be studied: a small diameter hydrogel string and a liquid gel that forms into a hydrogel once beneath the skin. Testing of the hydrogel will be done in vitro and will include biodegradability, injectability, and preliminary toxicology tests. Ultrasound detection and readout will use modified off-the-shelf devices.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.