SBIR-STTR Award

VivaScan has developed and successfully tested the Optical Bridg(TM) which uniquely nulls out the background, overcoming a major bottleneck in noninvasive blood glucose optical measurements. However, the current prototype makes use of an expensive acousto- optical filter (AOTF) which cannot produce monochromatic light, limiting the accuracy, reliability and marketability. These obstacles can be overcome by replacing the AOTF with tunable laser diodes (TLDs) which can potentially provide reliable, inexpensive monochromatic light at desired wavelengths. VivaScan and it's partner NASA Goddard Space Flight Center believe that current technology allows the fabrication of TLDs with the desired wavelengths of 1380am and 1620 rim. TLDs are not available since these wavelengths do not satisfy telecommunications requirements (typically 1300 - 1550 run). It is proposed that TLDs, having the desired characteristics, be developed and incorporated into the current prototype device which will be tested in vitro and in limited patient studies verifying the feasibility of replacing the AOTF with TLDs. For Phase II a noninvasive glucose monitor, the size of a "WalkMan" CD player, will be designed, built and tested. We anticipate improved accuracy, reliability, portability, ease of operation and affordability, allowing diabetic patients to painlessly determine their glucose level without drawing blood. PROPOSED COMMERCIAL APPLICATIONS: Our market analysis suggests that from 500,000 to 4.4 million diabetic individuals could use a noninvasive glucose monitor. The global market would increase these projections by a factor of 2 or more.

Project Terms:
Absorption; Advanced Development; Affect; Au element; Biological; Blood; Blood Glucose; Blood Sugar; Body Tissues; Calibration; Cell Communication and Signaling; Cell Phone; Cell Signaling; Cellular Phone; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; Computer Analysis; Computer Programs; Computer software; Contracting Opportunities; Contracts; Corium; Cutis; D-Glucose; Data; Data Set; Dataset; Dermis; Development; Device or Instrument Development; Devices; Dextrose; Diabetes Mellitus; Disease; Disorder; Ear; Ear lobe; Ear structure; Electromagnetic, Laser; Equilibrium; Evaluation; Fingers; Funding; Generations; Glucose; Goals; Gold; Grant; Guidelines; Health; Hemoglobin; History; Home; Home environment; Housing; Hydrogen Oxide; Individual; Intention; Intracellular Communication and Signaling; Label; Laboratories; Lasers; Lead; Left; Legal patent; Light; Lobule of the Auricle; Manufacturer; Manufacturer Name; Marketing; Measurement; Measures; Memory; Method LOINC Axis 6; Methodology; Methods; Modeling; Modification; Monitor; NIH; National Institutes of Health; National Institutes of Health (U.S.); Operation; Operative Procedures; Operative Surgical Procedures; Optics; Output; Outsourcing; Pain; Painful; Patents; Patients; Pb element; Performance; Persons; Phase; Photoradiation; Physiologic pulse; Pilot Projects; Procedures; Process; Process of absorption; Product Approvals; Public Health; Pulse; Radiation, Laser; Recording of previous events; Regulation; Reporting; Reticuloendothelial System, Blood; Risk; SBIR; SBIRS (R43/44); Safety; Sampling; Science of Statistics; Series; Signal Transduction; Signal Transduction Systems; Signaling; Site; Small Business Innovation Research; Small Business Innovation Research Grant; Software; Specific qualifier value; Specified; Staging; Statistics; Suggestion; Surgical; Surgical Interventions; Surgical Procedure; Technology; Telephone, Cellular; Testing; Time; Tissues; United States; United States National Institutes of Health; Water; Work; Writing; attenuation; balance; balance function; base; biological signal transduction; blood glucose regulation; clinical investigation; clinical practice; commercialization; comparative; computational analysis; computer program/software; cost; design; designing; detector; device development; diabetes; diabetes control; diabetic; disease/disorder; glucose control; glucose homeostasis; glucose meter; glucose monitor; glucose regulation; heavy metal Pb; heavy metal lead; imprint; instrument; instrument development; light transmission; meetings; pilot study; preclinical study; product development; prototype; public health medicine (field); surgery; user-friendly; volunteer

The goal of this project is to develop a handheld, noninvasive, personal blood glucose-measuring device. VivaScan has developed and successfully tested several laboratory prototype instruments whose operation is based on the Optical Bridge(TM) method. It uniquely nulls out the background absorption of the tissue, overcoming the major problem of optical blood glucose measurements. Our successful Phase I laser instrument patient pilot study produced 97.5% of the measurement data in the clinically acceptable A and B zones of the Clarke error grid, with 70.4% of the measurements in the A zone, with an average measurement error of 19.8%. The aims for Phase II include: 1) develop a laser diode system light source; 2) enhance electronics; 3) redesign and miniaturize the optics and device mechanics; 4) design a handheld VS-200 system based on laser diodes, microcontroller, and miniaturized optical & mechanical components; 5) further enhance the glucose measurement algorithms; and, 6) build three handheld devices and test their performance with patients. Overall, the goal of the proposed work is to extend our laboratory prototype system to a patient oriented affordable device, integrate inexpensive laser diode light sources, improve accuracy, achieve portability, and ease of operation. Subsequent FDA approval of a handheld personal blood glucose monitor will be sought, allowing diabetic patients to noninvasively and painlessly monitor their glucose levels throughout the day. VivaScan and its partner NASA Goddard Space Flight Center believe that the current technology allows the fabrication of Tunable Laser Diodes (TLDs) with the desired wavelength of 1380 nm. This TLD is not commercially available since its center wavelength does not satisfy telecommunications requirements. It is proposed that a TLD, having the desired characteristics, be developed and incorporated into the VS-200 device.

Thesaurus Terms:
biomedical equipment development, blood glucose, laser, noninvasive diagnosis, optics, patient monitoring device, portable biomedical equipment diabetes mellitus, infrared spectrometry bioimaging /biomedical imaging, clinical research, human subject