# 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

> **NIH NIH R44** · IDEAL MEDICAL TECHNOLOGIES, INC. · 2022 · $958,212

## Abstract

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.

## Key facts

- **NIH application ID:** 10482483
- **Project number:** 1R44DK133084-01
- **Recipient organization:** IDEAL MEDICAL TECHNOLOGIES, INC.
- **Principal Investigator:** Leon DeJournett
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $958,212
- **Award type:** 1
- **Project period:** 2022-06-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10482483

## Citation

> US National Institutes of Health, RePORTER application 10482483, 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 (1R44DK133084-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10482483. Licensed CC0.

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