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Development of an Autonomous Glycemic Control Mechanism for Patients Suffering Glycemic Abnormalities as a Result of Critical Illnesses

Award Information
Agency: Department of Defense
Branch: Defense Advanced Research Projects Agency
Contract: W912CG-20-C-0013
Agency Tracking Number: D2-2414
Amount: $779,227.96
Phase: Phase II
Program: STTR
Solicitation Topic Code: ST18C-004
Solicitation Number: 18.C
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-23
Award End Date (Contract End Date): 2021-07-22
Small Business Information
8 Saint Mary's Street Suite 624
Boston, MA 02215
United States
DUNS: 080018506
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Mike Rosinko
 VP, Research & Development
 (714) 365-4843
Business Contact
 Edward Raskin
Phone: (949) 293-2076
Research Institution
 Massachusetts General Hospital
 Dr. Steven Russell Dr. Steven Russell
50 Staniford Street Suite 301
Boston, MA 02114
United States

 (617) 726-1848
 Nonprofit College or University

It is well established that hyperglycemia of critical illness, general glucose intolerance, and insulin resistance are common among critically ill patients, including those without a diagnosis of diabetes mellitus upon hospital admission. Such glycemic dysregulation has been linked to increased patient morbidity and mortality, and longer recovery times. Furthermore, tight glycemic control has been shown to reduce morbidity and mortality, and to shorten recovery times. However, the current standard-of-care methods for glycemic control in the critical care and general ward settings are unable to achieve tight glycemic control while simultaneously avoiding hypoglycemia, which is an independent risk factor for death in the critical care environment. Our objective is to construct fully automated, fully integrated, bedside, closed-loop, investigational glycemic control systems to be used in a first-in-human inpatient clinical trial in patients with type 1 and type 2 diabetes. This system utilizes peristaltic pumps for automated, intravenous insulin and dextrose administration, and measures glucose levels with a body-worn sensor. We aim to publish the results from this inpatient trial and move the investigational platform design further, to a full-feature, commercial-ready design, as steps toward supporting pre-market approval discussions with the FDA.

* Information listed above is at the time of submission. *

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