SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project aims to develop a wireless, needle implantable miniaturized (0.5 x 0.5 x 5 mm) sensor for continuous glucose monitoring, with provisions for internal self-calibration without the need for frequent, external fingerpricking. The proposed internal self-calibration is enabled through the use of novel pulse-mode sensor operation which quantifies sensitivity drifts internally. Pulsed-mode operation also results in improved power management as well as long sensor lifetime. Biocompatible coatings release various tissue response modifiers to control tissue inflammation. The device can be inserted under the skin and similarly removed via a needle, thus avoiding surgical implantation/removal. Phase-I seeks to develop the internal self-calibration routines and demonstrate proof-of-concept ex vivo. Phase II will focus on extensive in vivo studies thereby facilitating commercialization. The broader/commercial impacts of this research are enormous considering that there is an urgent need for continuous glucose monitoring devices in view of the growing number of diabetics. Implantable glucose sensors that afford minimal user intervention present a viable alternative, although their "user-independent" nature is often undermined by necessity for frequent external calibration by finger-pricking. The proposed project will result in a truly "user-independent" operation of implantable glucose sensors. In addition, the proposed internal calibration methodology is universal to all biosensors used for metabolic monitoring, rendering competitive market edge and job creation. The project will be performed in the Technology Incubation Program (TIP), at University of Connecticut. This industrial/academic collaboration provides training for the graduate and undergraduate students in the field ofbiosensors.

This Small Business Innovation Research (SBIR) Phase II project aims to develop a wireless, needle implantable miniaturized (0.5 x 0.5 x 5 mm) sensor for continuous glucose monitoring, with provisions for internal self-calibration that ultimately eliminates the need for frequent, external finger-pricking. As part of Phase I project, the internal calibration routine has been developed and its ?proof-of-concept? has been demonstrated on an implantable glucose sensor unit operating in porcine serum for a period of 3 weeks. Along these lines, a proximity communicator (wrist-watch like unit) has also been developed which is in operable communication with the implantable unit. Phase II aims to further enhance the reliability of this calibration routine by demonstrating its efficacy in an in vivo environment (rat model) along with advancement of the proximity communicator unit in order to establish a two-way communication with a smartphone capable of real time data processing and implementation of the internal calibration routine. At the end of Phase-II, the completion of developmental activities for the self-calibrating glucose monitoring platform is envisioned, thereby, bringing it a step closer to commercialization in the pre-clinical animal research market (first market of Biorasis Inc.) The broader/commercial impacts of this project are enormous considering that there is an urgent need for continuous glucose monitoring devices in view of the growing number of diabetic patients. Implantable glucose sensors that afford minimal user intervention present a viable alternative, although their ?user-independent? nature is often undermined by the need for frequent external calibration via painful finger-pricking. The proposed project will result in a truly ?user-independent? operation of implantable glucose sensors. The successful implementation of such an advanced glucose monitoring technology, which can also be adapted for the management of other disorders (such as obesity and cardiovascular complications) will pave way for new jobs in our Stare of Connecticut and neighboring regions in the sectors medical devices, wireless communication and biosensors. The project will be performed in the University of Connecticut (UConn) Technology Incubation Program (TIP) in partnership with UConn collaborators. This industrial/academic collaboration provides training for the graduate and undergraduate students in the field of biosensors, optical powering, chip design and wireless data communication and will motivate them to US industrial competitiveness