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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是将一种新型且经济实惠的血糖监测系统商业化，该系统可间歇或连续测量血糖，无需电线、电子器件或物理附件。该项目系统针对2500万非胰岛素依赖型2型糖尿病患者（NIDT 2D），由于手指针刺的不便，尴尬和疼痛，他们不每天测量血糖水平或不按照医疗保健提供者的建议。医院、长期护理机构和生活在医疗服务不足地区的NIDT 2D患者也可以从该系统中受益。该系统结合了每两周注射一次的可生物降解传感器和外部读取器/发射器，当放置在传感器上时，读取并将葡萄糖水平传输到智能设备。数据被存储和/或传输给护理人员和提供者。该系统使NIDT 2D能够经常甚至连续地测量他们的葡萄糖，以更好地了解饮食和运动如何影响他们的葡萄糖水平。这个小型企业创新研究（SBIR）第一阶段项目是开发一种可生物降解，生物相容的水凝胶传感器，可以在皮肤表面下自我注射。该传感器将被设计为在生物降解成通过人体自然过程去除的无害成分之前具有14天的使用寿命。水凝胶将被调整以响应不同的超声频率，因此新注入的水凝胶不会干扰尚未完全完成其衰变周期的旧水凝胶。制造将使用在体内有长期成功使用记录的化学成分。具体地，采用创新方法将苯基硼酸基团嵌入改性的透明质酸主链中。水凝胶还必须适合通过细孔针而不损害其功能。将研究至少两种方法：小直径水凝胶线和一旦在皮肤下形成水凝胶的液体凝胶。水凝胶的测试将在体外进行，包括生物降解性、注射性和初步毒理学测试。超声波检测和读出将使用修改过的现成设备。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.