Microneedle-Based Miniaturized Continuous Glucose Monitor for Long Term, Factory Calibrated, Painless Sensing

SUMMARY Managing blood glucose with CGMsinsulin pumpsor integrated artificial pancreas systems has been shown to increase clinical outcomes for people with diabetesHowevernot all patients with diabetes adopt these technologies because they are apainfulbinvasiveand cexpensiveThe three FDAapproved tools for real time monitoring for glucose must all be implanted in the body fordaysmaking them neither ideal for people with Type I nor desirable for the hundreds of millions of people with Type II diabetes pre diabetesWe envision a painlesswirelesssmall form factor and inexpensive daily CGM which gives people with diabetes the freedom to wear the device easily and when they chooseA sufficiently easypainless and effective device which could monitor glucose as well as other analytes would also increase the likelihood of early diagnosis for diabetes and a host of other conditionsSpecificallywe have engineered a CGM which overcomes these key limitationsOurstrip on chipleverages microneedle technology and magnetic actuation to insert and remove individual needles the size of a human hairThis platform allows us to painlessly and accurately sample interstitial fluid from dermal and epidermal tissuemmSince the needles are exceedingly small and only transiently embedded within the skinmicroneedle based sensing is less invasive and causes less foreign body responseAdditionallymanufacturing the needles with high reproducibility leads to simpler factory calibrationdecreasing the cost of the device to roughly the cost of an existing test stripImportantly thestrip on chipcan be easily and painlessly appliedremoved at any timeand reapplied without changing the sensor moduleThe goal of this proposal is to determine the operating space and calibration space of our novel sensing and strategy for accessing sampleA successful outcome of this phase I application is two foldto determine that our sensor can perform in vitro as wellif not better thantheFDA approved CGM devices on the marketandto validate that our sensor can support a painlessminimally invasivecalibration free CGM deviceThis will provide the data necessary for the FDA IDE and feasibility human trial and the development of a sound manufacturing process that is at the heart of our Phase II proposal PROJECT NARRATIVE We have engineered a CGM which leverages microneedle technology and magnetic actuation to insert and remove individual needles the size of a human hairThis platform allows us to painlessly and accurately sample interstitial fluid from dermal and epidermal tissuemmWe request funding for performing a robust in vitro study to determine the operating and calibration space of our novel sensing strategy