StampPump will be a preâfilled disposable, postageâstampâsized (27x27x6mm), fullyâclosedâloop insulin pump that will carry enough ultraârapid U500 insulin to manage blood glucose for a full week. Our goal is to disrupt the insulin therapy market with a lowâcost system that delivers significantly better adherence and outcomes for Type 1 and Type 2 diabetics who need chronic insulin supplementation. This grant will enable proof of principle for the StampPumpâs fluidics and control systems. The specific aims are to refine and prototype designs of (1) reservoir, (2) pumping mechanism, and (3) subcutaneous cannula insulin delivery system and (4) to create a working breadboard prototype of fluidics and associated control electronics that meets bench testing benchmarks. Because StampPump is critically enabled by Thermalinâs ultraârapid acting, room temperature stable, U500 formulation of a novel insulin analog, demonstrating the systemâs compatibility with insulin is a subâaim. A followâon Phase II application would enable a large animal prototype and proof of concept.
Public Health Relevance Statement: StampPump, a preâfilled disposable, postageâstampâsized (27x27x6mm), fullyâclosedâloop insulin pump that will carry sufficient ultraârapid U500 insulin to manage blood glucose for a full week for >85% of Type 1 Diabetes patients, would be a disruptive (i.e., lower cost with more features) option that would dramatically lower the burden of insulin therapy, increase adherence, and improve outcomes & quality of life. This project will reduce risk of the project by delivering proof of principle for the required miniature fluidics and control systems.
Project Terms: 3D Print; Adherence; Adhesives; analog; Animals; Atmospheric Pressure; Back; Benchmarking; Biological Sciences; Blood Glucose; Cannulas; cell motility; Chronic; clinical development; Computer Simulation; cost; design; Detection; Devices; Diabetes Mellitus; Dose; Electronics; Elements; Ensure; Equipment; experience; fluid flow; Formulation; Funding; glucose monitor; Goals; Grant; improved outcome; Infusion procedures; innovation; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Investments; Life; Liquid substance; manufacturing process; Medical Device; Non-Insulin-Dependent Diabetes Mellitus; novel; Outcome; Paper; Patients; Pharmacologic Substance; Phase; Postage Stamps; pre-clinical; pressure; Privatization; Production; prototype; Pump; Quality of life; response; Risk; Schedule; seal; sensor; simulation; subcutaneous; Suction; Supplementation; Swimming; System; Technology; Temperature; Testing; T
