GOALI: Rapid Prototyping of Microscale Structures for Active Medical Devices and Characterization at FDA

North Carolina State University, Raleigh NC

Investigators

Abstract

1250724 Narayan Diabetes mellitus is a leading cause of morbidity and mortality in the United States. In addition, this medical condition disproportionately affects individuals from minority ethnic groups as well as older individuals. Although previous microneedle-based insulin delivery and glucose sensing efforts have envisioned microneedle-tissue contact for extended periods of time, no study to date has sought to optimize microneedle design in terms of biological, chemical, and mechanical properties for extended use within a wristwatch form factor device that is capable of 200 skin penetration events. The PI will partner with a leading US-based manufacturer of glucose meters, Prodigy Diabetic Care, to develop a comprehensive research, education, and outreach program that involves rapid prototyping of microneedles for use in insulin delivery as well as glucose sensing. The main benefit of the proposed collaborative research program is intensive access for the PI and the graduate researcher to the state-of-the-art equipment at Prodigy Diabetic Care, including equipment for preparing glucose oxidase, determining the consistency of glucose oxidase, determining blood glucose levels, preparing insulin patches, testing electronics, and designing meter containers. Five hundred square feet of space at Prodigy Diabetic Care will be devoted to the proposed GOALI effort. The research objective of this GOALI proposal is to apply a rapid prototyping method known as two photon polymerization and a recently-developed class of materials known as zirconium oxide hybrid materials to create hollow microneedles with appropriate chemical, biological, mechanical, and functional properties for extended use in a wristwatch form factor device.