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Lab-on-a-patch for neonates to monitor real-time glucose and reduce needle pain

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD088142-01
Agency Tracking Number: R41HD088142
Amount: $224,922.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: HD16-028
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-04-01
Award End Date (Contract End Date): 2018-03-31
Small Business Information
McLean, VA 22102-1602
United States
DUNS: 962122052
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (202) 994-4272
Business Contact
Phone: (703) 375-9267
Research Institution

DESCRIPTION provided by applicant This STTR grant is aimed to reduce pain from repeated needle pricks by improving the monitoring of glucose homeostasis GH in neonates by developing a real time glucose monitoring device The innovation utilizes a micro needle based lab on a patch platform invented by STTR partner George Washington University GWU GH is usually monitored by blood test via a heel stick or blood is sent to the lab for confirmation but variation from actual levels may be as much as mg dL Infants at risk for GH may require glucose testing every three hours or times day necessitating a needle prick on the heel to obtain a blood sample and then using a bedside reagent test strip glucose analyzers The lack of real time glucose monitors in neonates is a major unmet need for reducing sample volume collection and needle pricks A bendable stretchable microfluidic patch for real time monitoring of glucose using interstitial fluids or blood in NICU infants will be th first product for reducing pain and the frequency of needle pricks to once every hours This biosensor will securely communicate with a smartphone app via Zansors mobile health IT cloud system Proof of principle data by GWU was shown in Natureandapos s Scientific Reports Jan reporting a miniaturized lab on a patch technology integrating semiconductor CMOS sensors and electronics with microfluidics on a flexible substrate via liquid metal interconnects Zansorsandapos
possesses an innovative telemedicine system with encryption and HIPAA compliance that can be integrated to this proposed device Phase I Hypothesis A bendable stretchable sensor platform that integrates a hybrid of CMOS electrochemical sensors electronics chip microfluidic channels and stretchable electrical interconnects may use less interstitial fluid sample and less needle pricks and offer a real time sensor that monitors GH and continuously for long terms hours unobtrusively and then send the secure wireless data to a HIPAA compliant telemedicine mobile health cloud system Specific Aim Develop a wearable lab on a patch with micro needle Design electrochemical glucose sensors and CMOS electronics in COTS technology Finish the PDMS microfluidic device design and fabrication with soft lithography Specific Aim Adapt and calibrate the algorithm to compute GH from fluid data in real time and develop a mobile app to collect process analyze and store data from the device and communicate with a telemedicine and digital health cloud system Specific Aim Using glucose solutions demonstrate a proof of principle packaged bendable stretchable CMOS Microfluidic system for glucose monitoring The neonatal glucose monitor market is a subset of the larger continuous glucose monitoring CGM market CGM is set to grow to $ million by

PUBLIC HEALTH RELEVANCE In this Phase I STTR grant Zansors in collaboration with George Washington University will improve the monitoring of blood sugar of infants in the neonatal intensive care unit NICU by developing a real time glucose monitoring device which would be accurate and use a very small sample volume Most importantly the infant experiences reduced pain and less needle pricks because the bendable and stretchable lab on a chip technology can be placed on the infantandapos s heel once for hours instead of the current practice of repeated needle pricks every hours The sensor will be able to transmit wireless data to a health providerandapos s secure mobile phone and also to a mobile cloud system with HIPAA privacy

* Information listed above is at the time of submission. *

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