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

Description

PROJECT SUMMARY The long termgoal of this project is to develop a low costuser friendly glucose sensing solution with multi mode sensing reliability to enable the use of closed loop insulin delivery safely and reliably in an artificial pancreasThe system has the potential for fast sensor kinetics owing to small size and thin and flexible profile leading to better integration with the surrounding tissue and local vascularizationThis can enable automatic closed loop glucose control without meal announcements and carbohydrate countingIMS has developed a novelminiaturizedsmaller than half a sesame seedcompletely wirelessand extremely low cost glucose sensor that consists solely of a semiconductor deviceThis device can sense glucose owing to a novel microelectronics design and an integrated on chip electrochemical sensorThis device is injected in subcutaneous tissue using a proprietary inserter and wirelessly communicates the glucose data to an external transmitter device which relays it to a smartphone to enable data visualization and cloud based data handling to provide real time feedbackWith help of CaltechNIHand NSF fundingwe have e demonstrated sensor functionality in vitroin ratsandmost recently in porcine model for more thanmonthOur results indicate the sensor is very accurateMARDfor andltmg dl which is the most important rangeand can work for longer timemonthsafter some chemistry improvements i euse of catalase to minimize effect of peroxide denaturing of glucose oxidaseThereforeourobjective in this proposal is to develop a version of our wireless glucose sensing platform that can measure glucose usingtwo different sensing modalitiese gdifferential oxygen measurementand amperometric peroxide measurementtoincrease the reliability of the readoutThe use of these two modes extend the performance window of the implant by taking advantage of sensitive peroxide detection along with more stable differential oxygen sensingThe sensing platform will be tested in porcine model as it matches well with human skin and metabolismThis research issignificant as it will enable first factory calibrateduser insertable and removablewireless CGM sensor that can work for long timemonthsprovide reliability of redundant glucose sensingand fast response that can all enable safe and accurate closed loop glucose control in an artificial pancreasThe projectteamincludes original inventors of the core technology from CaltechDrNazariDrRahmanMrSencanseasoned and respected researcher in Glucose sensor technologyBill Van Antwerpexperimental surgery and biomaterials expertDrJonathan Lakey of UC Irvineand commercialization expertMrPeter Rule from MiniMedTherasenseand OptiScanThe company is working within IVD Technologies Incan ISO certifiedFDA registered biotechnology company under a facilities rental agreement Project Narrative Diabetes affects more thanmillion people worldwide more thanmillion of whom live in the USCGM is the technology of choice for diabetes managementby itself as well as in conjunction with insulin delivery devicespumpspensHoweverboth transcutaneousdue to tissue irritationCGM devices and recently approved wireless CGM devicesdue to large sizesuffer from significantly large blood ISF delay and adverse foreign body reactionIn this proposalwe intend to design a wireless glucose sensor that can minimize foreign body response due to its small size and thin profile that integrates better with surrounding tissueThis can result in a sensor that provides faster kinetics as compared to bigger or wired devicesand can work for long timemonthsIMS has proven the feasibility of a basic wireless sensor in lab benchandgtyearand in pigs for more thanmonthOur main goal in this proposal is to design a better version of the implant that extends the IMS sensor to enable it to measure glucose reliably by using two sensing modalitieswith longer lifetime due to superior electrochemistryThe above mentioned advantages alongwith with low cost and potentially fast kinetics can enable the use of artificial pancreas for a diverse range of patients for whom glycemic control otherwise is difficult leading to both morbidity and mortality