There is an urgent need for a long-term in vivo glucose-monitoring device for diabetes therapy. Diabetes is currently believed to afflict over 100 million people worldwide and nearly 18 million in the United States. In the U.S. this disorder, along with its associated complications, is ranked as the seventh leading cause of death. Research indicates that these long-term complications can be minimized in diabetics if blood glucose levels are maintained as near normal levels (60-110 mg/dL) as possible, so called """"""""tight"""""""" glucose control. The integration of continuous glucose monitor readings into an automatic insulin pump control algorithm may substantially increase both the safety and effectiveness of insulin therapy in diabetics. BioTex, Inc. has developed a superior fluorescence affinity glucose sensor which is one of the most promising technologies currently being pursued for application in diabetes research and therapy. The objective this Phase II proposal is to commence human clinical studies with the sensor under an investigational device exemption (IDE) from the FDA. The anticipated outcome will be a thorough characterization of the optimal implantation, instrumentation, and use of the sensor in humans and refinements of the associated accessories and procedures. At the end of this project we will be poised to commence larger human clinical trials in support of a pre-market approval (PMA) application to the FDA for marketing a 3-5 day implantable continuous glucose sensing system.

Public Health Relevance

BioTex, Inc. has successfully developed a minimally-invasive fluorescence affinity sensor (FAS) for continuous glucose monitoring over 3-5 days. The FAS has a number of advantages over currently available short-term implantable glucose sensors and is expected be a significant tool for diabetes research and therapy. Diabetes currently afflicts over 100 million people worldwide and nearly 18 million in the United States, and this disorder, along with its associated complications, is ranked as the seventh leading cause of death.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK076352-03
Application #
7937935
Study Section
Special Emphasis Panel (ZRG1-SSMI-Q (10))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2006-09-30
Project End
2012-08-31
Budget Start
2010-09-01
Budget End
2012-08-31
Support Year
3
Fiscal Year
2010
Total Cost
$423,874
Indirect Cost
Name
Biotex, Inc.
Department
Type
DUNS #
969792050
City
Houston
State
TX
Country
United States
Zip Code
77054
Dutt-Ballerstadt, Ralph; Evans, Colton; Pillai, Arun P et al. (2013) Acute in vivo performance evaluation of the fluorescence affinity sensor in the intravascular and interstitial space in Swine. J Diabetes Sci Technol 7:35-44
Dutt-Ballerstadt, Ralph; Evans, Colton; Pillai, Arun P et al. (2012) A human pilot study of the fluorescence affinity sensor for continuous glucose monitoring in diabetes. J Diabetes Sci Technol 6:362-70