Affinity Sensor-based Dual-Hormone Closed-Loop Glucose Control System

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$292,110.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK096686-01
Award Id:
n/a
Agency Tracking Number:
R43DK096686
Solicitation Year:
2012
Solicitation Topic Code:
NIDDK
Solicitation Number:
DK11-018
Small Business Information
8058 EL RIO ST, HOUSTON, TX, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
969792050
Principal Investigator:
RALPH BALLERSTADT
(713) 741-0111
ralph@biotexmedical.com
Business Contact:
ASHOK GOWDA
(713) 741-0111
ashok@biotexmedical.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): 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. 10percent 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 controlinvolves 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.

* information listed above is at the time of submission.

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