SBIR-STTR Award

Affinity Sensor-Based Dual-Hormone Closed-Loop Glucose Control System
Award last edited on: 8/28/14

Sponsored Program
SBIR
Awarding Agency
NIH : NIDDK
Total Award Amount
$367,110
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Ralph Ballerstadt

Company Information

BioTex Inc (AKA: Visualase)

8058 El Rio Drive
Houston, TX 77054
   (713) 741-0111
   ashok@biotexmedical.com
   www.biotexmedical.com
Location: Single
Congr. District: 09
County: Harris

Phase I

Contract Number: 1R43DK096686-01
Start Date: 9/15/12    Completed: 8/31/13
Phase I year
2012
Phase I Amount
$292,110
The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10 percent of this type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose control involves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application, BioTex scientists and engineers will investigate and develop a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy. The major objective in the Phase I is to demonstrate feasibility and efficacy of the blood-glucose regulation in a diabetic swine model (anesthetized), using real-time data from the FAS device, and run by a well- described, and validated model-predictive control (MPC) algorithm. If successful, in Phase II the validation of these results will then be performed in ambulatory experiment using diabetic pigs with a wireless FAS monitor, followed by pilot studies in humans.

Public Health Relevance:
The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10 percent of these type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose control involves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application scientists and engineers of BioTex, Inc will develop and investigate a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy.

Public Health Relevance Statement:
The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10 percent of these type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose control involves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application scientists and engineers of BioTex, Inc will develop and investigate a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy.

NIH Spending Category:
Autoimmune Disease; Bioengineering; Biotechnology; Diabetes; Pediatric; Pediatric Research Initiative

Project Terms:
Affect; Affinity; Algorithms; Animal Model; Artificial Pancreas; base; Blood Glucose; blood glucose regulation; Characteristics; Computer Simulation; Computers; Control Groups; Cytotoxin; Data; design; Detection; Development; Devices; Diabetes Mellitus; diabetes mellitus therapy; diabetic; Ear structure; Engineering; Euglycemic Clamping; Family suidae; Feasibility Studies; Fluorescence; follow-up; Generations; Glucagon; Glucose; Glucose Clamp; glucose monitor; glucose sensor; glycemic control; Hormones; Human; Hypoglycemia; improved; Incidence; Individual; Infusion procedures; Infusion Pumps; innovation; Insulin; Insulin-Dependent Diabetes Mellitus; Intravenous; intravenous administration; laptop; Literature; Measures; meetings; Methods; Minor; Modeling; Monitor; next generation; Noise; Outcome Measure; Phase; Pilot Projects; Population; pre-clinical; preclinical study; predictive modeling; research study; Running; Safety; Scientist; sensor; Simulate; simulation; Streptozocin; System; Technology; Testing; Time; usability; Validation; validation studies; Veins; Wireless Technology; World Health Organization

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
$75,000