NEEDLE FREE INSULIN INFUSION WITH THERMAL MICROPORATION

The goal of this proposal over Phase I and II SBIR studies and subsequent full scale development is to commercialize a noninvasive insulin infusion system that is painless, convenient, discrete, safe, efficacious and cost-effective. Such a system will bridge the gap between the tight glucose control currently recommended by the American Diabetes Association and the convenience and quality of life desired by persons with diabetes. This system will be based on a proprietary thermal microporation technology which eliminates the barrier function of the stratum corneum to percutaneous infusion. We hypothesize that a thermal microporation based infusion system can controllably deliver insulin over an extended period of time in a manner similar to insulin pumps available on the market today. Phase I efforts demonstrated the feasibility of an insulin infusion system which combines the thermal microporation method with iontophoresis. Phase II efforts will focus on patch design and insulin formulation to optimize the product as well as evaluating the capabilities, repeatability and controllability of a MicroPor(TM)-based insulin infusion system.