The long term goal of this proposal over Phase I and II SBIR studies and subsequent full scale development is to commercialize a non-invasive insulin infusion system that is painless, inexpensive, convenient, discrete, safe and 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 diabetics. 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. This Phase I effort will evaluate the feasibility of an insulin infusion system which combines the thermal microporation method with iontophoresis. This study will focus on determining initial delivery feasibility by monitoring both serum insulin, serum C-peptide, and blood glucose before, during and after the delivery period. Subsequent Phase II effort will address how this system can be refined to develop a desired pharmacokinetic infusion profile in a cohort of diabetic subjects. The Phase II portion will also address the questions of any inter- or intra-subject repeatability issues discovered during Phase I, the use of additional flux enhancer techniques, the dynamics of bolus delivery and the design of the low cost disposable infusion element.
The ultimate goal is the development of a needle-free, cost effective insulin infusion system. The entire system could be made to be worn like a pager electrically connected to a disposable infusion patch. Alternately, a small hand held unit could be briefly connected to an infusion patch to create the thermal micropores once every twenty-four hours, and then a small processor in the patch could control the insulin delivery profile.