There is an urgent need for a new glucose sensor that is: (1) highly reliable and continuous; (2) capable of automatic function, independent of user initiative, to warn of hypoglycemia; and (3) acceptable to users. We have an implantable electrochemical glucose sensor that can potentially meet this need. A prototype of this sensor has operated continuously as a central venous implant in dogs for over 100 days without the need for recalibration and now in humans for over one year. This achievement still represents the published world's record for implanted glucose sensor longevity. For reasons of safety, we are designing a tissue glucose sensor for long-term use in humans. The implant will include the sensor, electronics and telemetry, antenna, and battery. Glucose signals will be transmitted to an external receiver resembling a beeper that will display the actual glucose value and function as a hypoglycemia alarm. Our recent studies have focused on developing a complete understanding of the tissue sensor response to blood glucose. The working hypothesis is: """"""""A useful analytical relationship exists between the signal of sensors implanted in tissue and blood glucose concentration."""""""" We have: defined sensor performance requirements, developed methods of sensor fabrication, implanted sensors in a well-defined hamster model, established novel confocal microscopy methods for non-destructive visualization of the tissue/sensor interface, and modeled sensor response. We will extend our studies by implanting sensors in pigs and carry out extensive analysis of sensor system dynamics, including development of a method for sensor recalibration, further documentation of implant biocompatibility, and establishment of system reliability. These studies will be carded out in addition to our continuing studies in hamsters and diabetic rats. These studies set the stage for trials in humans.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK064570-03
Application #
6789421
Study Section
Special Emphasis Panel (ZRG1-SSS-F (02))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2002-09-30
Project End
2005-08-31
Budget Start
2004-09-01
Budget End
2005-08-31
Support Year
3
Fiscal Year
2004
Total Cost
$304,000
Indirect Cost
Name
University of California San Diego
Department
Engineering (All Types)
Type
Schools of Arts and Sciences
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Lucisano, Joseph Y; Routh, Timothy L; Lin, Joe T et al. (2017) Glucose Monitoring in Individuals With Diabetes Using a Long-Term Implanted Sensor/Telemetry System and Model. IEEE Trans Biomed Eng 64:1982-1993
Wessling-Resnick, Marianne (2015) Nramp1 and Other Transporters Involved in Metal Withholding during Infection. J Biol Chem 290:18984-90
Kumosa, Lucas S; Routh, Timothy L; Lin, Joe T et al. (2014) Permeability of subcutaneous tissues surrounding long-term implants to oxygen. Biomaterials 35:8287-96
Gough, David A; Kumosa, Lucas S; Routh, Timothy L et al. (2010) Function of an implanted tissue glucose sensor for more than 1 year in animals. Sci Transl Med 2:42ra53