SBIR-STTR Award

Diabetes is an increasingly common lifelong disease. Diabetes is associated with many complications, and it is responsible for an estimated 10-15% of all health care expenditures. Effective treatment has been shown to prevent or delay many of the associated complications. The most common current treatments include diet, exercise, and self-monitoring of blood glucose (SMBG). An improvement to current SMBG methods would enable and encourage patients to monitor their glucose levels more closely, improving the general health and quality of life of the diabetic population. Sensor Technologies Inc. has developed a minimally invasive glucose sensor. The technology is based on a small optical sensor implant that is fluorescent in the visible region of the spectrum and detectable through the skin. The sensor is highly specific for glucose, and is based upon fluorescence resonance energy transfer. Functionality, durability and biocompatibility have been demonstrated in a small animal model, and a hand-held measurement device has been completed. The next steps require that the kinetics of the sensor response to changes in glucose under physiological conditions be investigated. The goal of the proposed studies is to optimize sensor kinetics both in vitro and in vivo without compromising sensor biocompatibility, lifetime, and signal-to-noise

This Phase II SBIR involves the testing of a minimally invasive glucose sensor in vivo. Diabetes is an increasingly common lifelong disease and is associated with many complications. It is responsible for an estimated 10-15 percent of all health care expenditures. Effective treatment has been shown to prevent or delay many of the associated complications. The most common current treatments include diet, exercise, and self-monitoring of blood glucose (SMBG). An improvement to the current method would enable and encourage patients to monitor their glucose levels more closely and thus improve the general health and quality of life of the diabetic population. The technology is based on a small optical sensor implant that is fluorescent and detectable through the skin. We will finalize the sensor configuration to obtain the fastest kinetics. Animal efficacy trials must be performed to bring the sensor closer to clinical trials in humans. The performance of the sensor will be studied in vivo to demonstrate that the sensor correlates with blood glucose and follows glucose changes in tolerance tests. In vivo testing will be performed to determine the recalibration interval, the reproducibility, and the accuracy of the sensor. The lifetime and biocompatibility of the sensor will also be determined. PROPOSED COMMERCIAL APPLICATION: An improvement in the current method of measuring glucose levels would enable and encourage diabetic patients to measure glucose levels more frequently at home and thus improve the general health and quality of life of the diabetic population. An advance in the glucose sensing technology would greatly impact the diabetes market. A large commercial market currently exists for innovative improvements on glucose detection such as the minimally invasive glucose sensor and accompanying meter described in this research.

Thesaurus Terms:
biomedical equipment development, biosensor, blood glucose, chemical kinetics, diabetes mellitus, diagnosis design /evaluation, fluorescence resonance energy transfer, measurement, patient monitoring device clinical biomedical equipment, optics, portable biomedical equipment laboratory mouse, laboratory rat