Integrated Medical Sensors — Department of Health and Human Services SBIR Phase I: 200

Description

DESCRIPTION provided by applicant 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 million people worldwide with an estimated increase of about million by the year 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 PUBLIC HEALTH RELEVANCE Diabetes is a chronic disease affecting around million people worldwide and is growing at epidemic proportions Diabetes management requires a good control on patientandapos s glucose level throughout their daily life Current glucose measuring systems involve home glucose meters requiring blood drops from finger pricks to measure patientandapos s glucose level 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 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 andapos transmitterandapos 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