The problem we solve: Ineffective glucose control in the ICU setting leads to high rates of hyperglycemia, hypoglycemia and increased glucose variability. This altered glucose state adversely affects the white blood cells and sets off the bodies inflammatory cascades, which leads to increased infections and multiple organ failure. Glucose control is currently done via an open loop method whereby the nurse manually checks the glucose level, manually enters this into an insulin dosing calculator, and manually adjusts the intravenous rate of insulin infusing into the patient. This method is not very effective and is very time consuming. There are currently no approved artificial pancreas systems available for use in the hospital setting in either the U.S. or European Union.
About our solution: Our FUSION artificial pancreas system is a fully autonomous closed loop glucose control system that will only take 10 minutes to set up and will provide far more effective glucose control than can currently be achieved by the current open loop method. In addition, it will free up the nurses to spend more time in direct patient care. This will be very important during the COVID-19 pandemic as there will be a critical shortage of ICU nurses.Progress to date:
We already have a working prototype and have finished all of our preclinical testing, thus at this time we are ready to begin clinical studies. We had planned on pursuing a step wise approach to our clinical studies with plans to bring our FUSION sytem to market by Q1 2022. However, given with the current COVID-19 pandemic causing a daily loss of life now approaching one thousand people, our new plan is to accelerate testing of a beta version of our FUSION system by June 2020. We should be able to accomplish this as our glucose control software and operating system have already been fully developed and we plan to use off the shelf continuous glucose monitors (e.g., Dexcom G6 or EIRUS) and intravenous pumps. Once we prove the safety of the beta version of our FUSION system in an early feasibility study in ICU patients, we will petition the FDA for an Emergency Use Authorization given its potential to lower ICU mortality rates during the pandemic.
Creator: Leon DeJournett
Location: North Carolina
Education: Chicago Medical School-Rosalind Franklin
Bio: Dr. Leon DeJournett has more than thirty years of experience working in the intensive care unit (ICU) setting. He first became interested in glucose control in the ICU in 2007. After performing an extensive review of the literature in this area, he realized that the control methods in use at that time would not be able to provide safe and effective glucose control as they were not capable of keeping up with the highly dynamic blood glucose levels seen in ICU patients. By combining his ICU experience, a deep understanding of how the native system works, and computer coding skills, he was able to write algorithms that mimic the workings of the native pancreas (insulin release) and liver (glucose release), as it pertains to glucose control. These algorithms exhibit biomimicry and form an expert based rule system, which is considered a form of artificial intelligence (AI). Dr. DeJournett has several peer reviewed publications related to the testing of this AI based glucose control software, including a recent publication that showed superior glucose control when it was tested head up against an ICU physician. In 2014 he formed the Ideal Medical Technologies corporation and subsequently led its development efforts of a closed loop glucose control system (artificial pancreas), which has been given the name FUSION. He led the effort to obtain Breakthrough Medical Device designation status for the FUSION system, which was granted by the FDA in 2019 as an acknowledgement that the FUSION system has the potential to decrease the mortality rates of ICU patients. There are currently no approved artificial pancreas systems available for use in the hospital or ICU setting in either the U.S. or EU. Dr. DeJournett received his medical training at Stanford University Medical Center.
Hospital Affiliation: Ideal Medical Technologies
Title: Founder, Chief Medical Officer
Advanced Degree(s): MD
Biography: Alan Jernigan has more than 25 years of progressively responsible experience directing as many as 300 employees in companies with revenues in excess of $3 billion. Alan has led these companies through start-up, survival, turnaround, growth modes and successful exit. Alan has spent 20 years as a Senior Executive in a variety of medical, pharmaceutical and biotech industries both on the human and veterinary side. His understanding of both domestic and international point of care sales/marketing/distribution channels & markets encompasses physician offices, hospitals, military and retail clinic sales, wholesale, OEM, with both direct and indirect sales forces. He has personally been involved with successfully launching and growing over 50 medical device, point of care & IVD diagnostic products. Among his significant previous positions, Alan has served as CEO of three different start-ups which had successful exits and returned significant value for its shareholders. He has also held several VP sales & marketing for large and start-up companies such as Abbott, Roche, ThromboVision Inc., and IGEN. Alan Jernigan holds a Bachelor of Science degree from Oklahoma State University and a Master of Business Administration (MBA) degree from Oklahoma City University.
Advanced Degree(s): MBA
Chief Technical Officer, BS, Electrical Engineering
Biography: Jeremy DeJournett serves as the technical lead and acting Chief Technology Officer for Ideal Medical Technologies. He graduated from the North Carolina School of Science and Mathematics in May 2012, and completed a Bachelor of Science in Electrical Engineering from the University of Illinois at Urbana-Champaign in May 2018. While in college, he worked with a NASA funded CubeSat lab through the Satellite Development Organization, and successfully delivered the CubeSail satellite to Rocket Lab in March of 2018. He was responsible for delivering high level technical reports to principal investigators, as well as translating requirements into technical specifications for the embedded software development team that he led. In parallel to this work, he was key to the development of Ideal Medical Technologies’ technical stack. During the fall of 2015, he completed the first major revision of the FUSION software, which was used to run a pre-clinical trial at Wake Forest in December 2015. The following summer, he developed the FUSION simulator, which was used to perform large scale combinatorial analysis of the FUSION software, and to demonstrate the efficacy of the control methodologies in both typical and difficult clinical and non-clinical scenarios. Through winter of 2016 and spring of 2017, he further extended the FUSION simulator to support other glucose controllers that have seen clinical use, which was used to publish a comparative study of the FUSION controller. He successfully integrated the FUSION controller with the EIRUS CE marked continuous glucose monitor from Getinge, AB, and tested this working prototype in pre-clinical trials in October 2018. This work included fault tolerance analysis, drug delivery verification, and user interface improvements. He has produced all of the system design and technical documentation required for the Investigational Device Exemption application to the FDA.
Title: Chief Technical Officer
Advanced Degree(s): BS, Electrical Engineering
If you or someone you care for has ever been admitted to an intensive care unit (ICU), you can understand how stressful this situation can be for a persons body. What you may not have realized is how important it is to keep the blood glucose level of critically ill patients locked into a zone, such as 100-140 mg/dL, while simultaneously avoiding hypoglycemia and extremes of glucose fluctuation (variability). ICU nurses sometimes have to care for up to 3 patients at a time, and with the current COVID-19 pandemic this number may rise to more than 3 patients per ICU nurse as there will end up being a shortage of ICU nurses. The only way to lock in the glucose level of an ICU patient is to use an artificial pancreas system. The ICU nurse cannot possibly maintain tight control of their patients glucose level by checking it every 1-4 hours, as the glucose level of an ICU patient can fluctuate at a rate of up to 3 mg/dL/minute! Thiis means that it can change by more than 100 mg/dL over the course of one hour. Only by following the blood glucose level with a continuous glucose monitor that gives new glucose readings at least every 5 minutes, and adjusting the rates of insulin and glucose (dextrose) flowing into the critically ill patient, can you hope to keep steady a critically ill patients glucose level. Our FUSION system uses both insulin and glucose infusions to maintain control of the glucose level, and makes adjustments every 5/10 minutes to its infusion rates. Altered glucose metabolism in ICU patients is a silent but very real killer! We believe our FUSION system will work just as well on diabetic patients in a non-ICU setting, as they also suffer from poor glucose control using the current control method of subcutaneous insulin injections 2-3 times/day. If you have diabetes and have ever been admitted to the hospital, you will understand how difficult it is for your nurses/doctors to achieve safe and effective glucose control. Only through mimicking how the bodies natural glucose control system works can we hope to achieve safe and effective glucose control for very sick hospitalized patients. This is how the FUSION system works, through biomimicry.
If you provide care for patients in the hospital setting, you know how difficult it can be to achieve safe and effective control of a patients blood glucose level. With the current open loop methods, the bedside nurse must manually check the patients blood glucose level, manually enter this value into an insulin dosing calculator or refer to the insulin order set, then manually administer the insulin (e.g., adjusts IV pump for ICU patients or gives subcutaneous injection for diabetic patients in a non-ICU setting). This can lead to human error at all three steps. The current open loop method is time consuming and frankly not very effective. Despite all of the evidence supporting improved patient outcomes with safe and effective glucose control in both the ICU and non-ICU setting, we still do not have any approved artificial pancreas systems available for use in the hospital setting, let alone one that can actually achieve a high level of control. Imagine if glucose control could be as simple as the physician ordering what glucose range they want their patient to be in and our FUSION system locks the patient into this range with no hypoglycemia and minimal glucose variability. The FUSION system only takes 10 minutes to set up, thus the nurse will be freed up to spend more time on direct patient care, which should also serve to improve both patient outcomes due to the increased time the nurse can spend in direct observation of their patient, and patient satisfaction as they will be seeing more of their nurse.
If you are a hospital CEO, CFO or CMO you need to realize how big a problem inpatient glucose control is. While ICU beds may account for less than 10% of your total bed capacity, ICU patients account for almost 15% of your total patient costs. Caring for ICU patients is expensive! In addition, diabetic patients make up 25-30% of your patient volume admitted into a non-ICU setting, and as they tend to spend almost a week in the hospital, they account for more than 30% of your patient costs when looking at just the non-ICU bed environment. Your reimbursement for Medicare and Medicaid patients (typically >50% of your patients) is based on the patients diagnostic related groups (DRG's). This is a fixed reimbursement, thus anything you can do to decrease the cost of caring for these patients will improve your profit margin. As you most likely operate with a profit margin of 2-5%, even small improvements will help you maintain your hospital as an ongoing business concern (true for both nonprofit and for profit hospitals). Studies have shown that ICU patients with improved glucose control achieve cost savings in the range of $1,500-$4,000 per patient (Krinsley, Chest, 2006; Sadhu, Diabetes Care, 2008). Studies have also shown cost savings of $50,000 per patient in the group of abdominal surgery patients who did not experience any hyperglycemia in the post operative period (Buehler, J of Diabetes Complications, 2015). This was true for both diabetic and non-diabetic patients, thus the benefits of safe and effective glucose control may extend as well into the non-diabetic patient population undergoing major surgeries. This abdominal surgery study was done on non-ICU patients. With an average ICU length of stay of 4 days, you should be able to use the FUSION system 90 times per year. If the FUSION system produces net cost savings of $1,500 per patient, this will lead to annual cost savings of $135,000 for each FUSION system in use. The FUSION artificial pancreas system will be a complete win for your hospital - better patient outcomes, improved nursing efficiency, one less patient issue for physicians to stress about, improved hospital financial performance.
Our FUSION system will be of major benefit to the U.S. government and insurance companies, especially with the current COVID-19 pandemic. ICU care is very costly, with the average ICU patients care costing $25,000 ($150 billion/year for 6 million patients/year = $25,000/patient). For more complicated ICU patients who spend more than 4 days in the ICU the cost of their ICU care can easily exceed $100,000. Both the U.S. government and insurance companies are going to end up paying for the care of the upcoming wave of COVID-19 ICU patients, and our FUSION system has the potential to decrease the total cost of this care. In addition, once the COVID-19 pandemic has passed, our FUSION system will continue to decrease the cost of caring for ICU patients and diabetic patients in a non-ICU setting in perpetuity. Finally, because our FUSION system works autonomously and requires very little expertise to run, it will allow for safe and effective glucose control to be achieved for hospitalized patients throughout the world.
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