SBIR-STTR Award

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 design, build, and test a fully automated, fully integrated, bedside, closed-loop, portable glycemic control system for deployment in the critical care and general ward settings. This system would utilize peristaltic pumps for automated, intravenous insulin and dextrose administration and measure glucose levels with a body-worn sensor. The scope of this Phase I proposal includes the construction of two such prototype systems and bench-top verification testing of both systems against design requirements. Phase II efforts would involve the start of validation testing in an exploratory first-in-human clinical trial.

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.