The broad long term goal of this project is to empower diabetic patients (type I and type II) with a low-cost easy-to-use technology that helps them manage their disease. Diabetes affects more than 400 million people worldwide with an estimated increase of about 205 million by the year 2035. Due to the dramatic increase in the growth of diabetes, the development of a low-cost and effective device that allows close monitoring of glucose level and managing the disease is of high relevance to the NIH as well as other world health organizations. We have prototyped a novel, miniaturized (size of a poppy seed), completely wireless and extremely low-cost glucose sensing system. It consists of an electronic microchip which can sense glucose owing to an integrated electrochemical solid-state sensor. This device is injected sub-dermally using a proprietary needle-based applicator and wirelessly communicates the glucose data to an external transmitter device which enables cloud-based data storage and processing. The next step in transforming this technology into a commercial product is the development of reliable and scalable processes to allow for high-yield manufacturing of the sensor with long-term in-vivo operation. In this Phase I project, we propose to formulate, optimize and test the performance of the device in-vitro and then test its efficacy i an established animal model (rats).
Diabetes is a chronic disease affecting around 400 million people worldwide and is growing at epidemic proportions. Diabetes management requires a good control on patient's glucose level throughout their daily life. Current glucose measuring systems involve home glucose meters requiring blood drops from finger pricks to measure patient's glucose level, 5-6 times a day. A more continuous mode of measurement is use of transcutaneous devices which have a fine needle and wire assembly going through skin and are connected to an external electronics system which measures glucose levels continuously. Other than the short lifetime of about 7 days, such transcutaneous devices pose infection and skin irritation risks as well as risks of issues with lifestyle and device movement. Completely wireless implants can be a solution to this problem and have been the focus of many research efforts. In this proposal, we present a first of its kind, extremely small, low-cost and modern sensor technology that can perform continuous measurements for few months and is read using an external wireless device. We have demonstrated the functionality of our wireless devices through extensive in-vitro and preliminary in- vivo testings. We have built a fully-functioning prototype system consisting of the wireless sensors, an external wireless 'transmitter', a smartphone reader and a web-based data interface. However, we note sensor to sensor variations due to the current status of sensor processing techniques in academic settings. This makes it difficult to quantify the sensor performance and compare it with other sensors, both in-vitro and in-vivo. Hence, in this SBIR Phase I application, we are proposing to optimize the sensor processing methods (sensor fabrication and membrane chemistry deposition) to reduce sensor to sensor variability and achieve information on accuracy of our devices. The ultimate goal of this phase is to formulate a sensor fabrication process to achieve accuracy and safety required for initiating first in man studies. We have been discussing the clinical aspects of our technology with reputable medical professionals, including Dr. Anne Peters at USC and Dr. Fouad Kandeel at the City of Hope. We would continue these engagements to formulate a collaboration to test and validate the device functionality in clinical settings during the phase I of this SBIR proposal.