Demonstration of the Feasibility of Closed Loop Control of Blood Glucose in the Intensive Care Unit Setting Using a Novel Artificial Intelligence Based Glucose Control System

PROJECT SUMMARY Failure to achieve tight glucose control in intensive care unit (ICU) patients is a major cause of morbidity and mortality. The current method for controlling glucose for the almost 6 million patients admitted to the ICU each year consists of time-intensive, error-prone, manual processes in which nurses have to check patient glucose levels, calculate dosing and rates for intravenous (IV) insulin, and adjust IV pumps. These steps can decrease nursing efficiency by up to 2 hours per patient per day. Ideal Medical Technologies is developing an improved system for glucose control in ICU patients. FUSIONTM, our closed-loop glucose control system, acts as an artificial pancreas; our innovation centers on using biomimicry to design our artificial intelligence-based algorithms so that they function like the glucose regulation system natively present in humans. These algorithms allow FUSION to continuously monitor a patient’s blood glucose level and autonomously infuse insulin and/or dextrose into the patient to maintain the blood glucose level within a physician-prescribed range. An automated, closed-loop approach to regulating glucose in critically ill patients would represent a paradigm shift in treatment protocols, and ultimately, morbidity and mortality rates in the ICU. One potential additional benefit of a closed-loop glucose control system beyond improved patient outcomes is the possibility of decreasing nursing time spent on glucose control. The FDA designated FUSION as a Breakthrough Medical Device in 2019, and our original IDE application was approved by the FDA as of this year. In this proposed project, we intend to optimize a commercial FUSION system and test it first in a 10-person non-randomized clinical safety trial and then in a 30-person randomized controlled safety and efficacy trial – both trials will be performed in an ICU at Emory University. Successful completion of this project will demonstrate clinical safety and preliminary efficacy of the FUSION closed-loop glucose control system and will enable us to then move into larger efficacy Phase III trials in a subsequent stage of development and commercialization; these Phase III trials will complete our data package for the FDA for marketing approval.