Monarch’s second annual EndoTool User Group Meeting is fast approaching, providing a forum for EndoTool users to discuss new product features and trends in the industry, as well as the best practices for education and implementation. As we look forward to this year’s event and continue to discuss how we can advance inpatient glycemic management, we also want to reflect on how we got here.
In a Q&A with Dr. Patrick Burgess, MD, PhD, the founder and inventor of EndoTool, we discuss the early development of EndoTool, his experience, and the research he plans to share at this year’s User Group Meeting.
Q: How did you come up with the idea to create EndoTool?
A: While practicing nephrology at Carolinas Medical Center, I was asked to help with the glycemic control in a cardiovascular recovery unit because of the immense pressure being placed on the surgeons to reduce their sternal infection rate. I tried the published paper protocols with partial success and much angst by the nursing staff. The protocol consisted of a few decisions and mathematical calculations that took up a lot of time from the nurses’ busy schedules. We had reached only half of our goal using a paper protocol, so I proposed to the surgeons that I could control the glucose levels with a computer program that would take the math to the next level and be less work for the nursing staff. A month later we had normal glucose levels on the first morning post-op, no sternal infections, a happy staff, and an extremely low incidence of hypoglycemia. An endocrinologist looked over my shoulder and suggested we make it commercially available.
After three months of trying to practice nephrology and developing a product, I decided that I would turn all my focus and efforts into the development of EndoTool. It was a difficult decision, but not a regretted one because I have touched more patients than I could have ever seen in practicing medicine. Even though I was the inventor of EndoTool, it would be injustice to take all the accolades of it because the former CEO, Shade Mecum, software developers, John Thornley and Paul Hester, and the initial nursing staff, including Laura Santana, have contributed heavily to all aspects of the software and delivering it to hospitals for patient care.
Q: Before EndoTool was invented, how were doctors and nurses dosing insulin in hospitals? What were some of the challenges with that approach?
A: Prior to EndoTool, there were paper protocols that were disliked by a majority of healthcare professionals. These protocols were often used selectively only for the patients with very high blood glucose levels. When I reflect back on the early days, I now realize that the acceptance of the staff to this new approach was partially a reflection of the nursing staffs’ understanding that I was not only trying to control high glucose levels, but was also committed to reducing the work load and stress on the staff related to glucose control by providing safe and effective dosing without increasing the caregiver’s work load. An event of a low glucose causes risk to the patient, more time and effort by the bedside caregiver, and increased costs to the hospital. Studies have uniformly revealed the poor outcomes are associated with these hypoglycemic events.
Q: What was the early feedback from patients, doctors and nurses about EndoTool?
A: Honestly, it was a mixed response. Often, there was resistance or push back from physicians and even nurses. However, all became more enthusiastic about a system as they used it and saw it give them the same response 24/7, allowing for control and patient safety to be achieved simultaneously with EndoTool. I believe the push back was related to managing ‘change’ because medicine is slow to change old standards of care.
Q: How have you seen the industry evolve since you started the business as it related to glucose management of in-hospital patients?
A: The first major glycemic control articles were from Van den Berghe (2006) who showed that glycemic control leads to improved outcomes, based on the basic science of the expected effect of high glucose levels on the immune system, lymphocytes, and the potential for dehydration and acute kidney injury. Based on her articles, I developed EndoTool to bring control to the 110 to 120 mg/dL goal range.
The NICE-SUGAR study instead reported better outcomes from a high goal range compared to what they called ‘tight’ control. The true finding of that study simply confirmed the effect of severe hypoglycemia on the human body. Low glucose levels (less than 40 mg/dL) related to frequency and presumably the length of time at a low glucose level are highly associated with mortality. The brain cells require glucose as the fuel for cerebral metabolism and when the glucose level begins to get too low, the brain is at high risk to be injured. That injury can be manifested in one of many presentations: from decreased mental status, to seizures, and brain death. This caused the industry to focus on the prevention of hypoglycemia regardless of the level of hypergylycemia, and as a result, patients blood glucose levels remain high.
The NICE-SUGAR study simply confirmed that controlling glucose had to be done safely because the subjects in the tight control cohort had much longer stays and a higher death rate with an order of magnitude higher incidence of hypoglycemia. I believe Van den Berghe had the correct concept and EndoTool is a way of providing the math to find a patient’s specific narrow window of therapeutic efficacy for insulin and to adjust that window in time as the patient’s resistance to insulin changes during the healing process.
Q: How do you think the industry needs to improve the in-hospital patient experience and outcomes as it relates to glycemic management and insulin dosing over the next few years?
A: The industry must use science-based approaches to glycemic management. The therapeutic range for dosing insulin is very narrow and is highly patient dependent and stress related, which often changes in time significantly. The hospital industry needs to embrace glycemic management and patient education. Hospitals have historically sent the wrong messages to patients by leaving their glucose levels high when hospitalized. This portrays the wrong message that glycemic management is not important when hospitals are so imprecise with respect to glycemic control.
Q: What has been the best aspect about being the inventor and founder of EndoTool?
A: What has been most rewarding is knowing that I have provided a ‘tool’ for physicians to safely achieve glycemic control that simplifies the workflow for the bed-side caregiver and provides a significant return on investment for the hospital with decreased infection and shorter length of stay, while also showing patients that glucose levels can be controlled safely. My primary goal when starting the process of developing EndoTool was to benefit the three stakeholders: nurses, hospitals, and most importantly patients who are sent home with instructions and proof that glycemic control is possible.
Q: Can you give us a preview on what you plan to cover at this year’s User Group Meeting?
A: We’ve collected data from 15 hospital systems with more than 5 million data points and plan to share the comparison of data before and after Estimated Residual Extracellular Insulin (EREI) was implemented into the algorithm. The EREI adjustment was added in 2014 after FDA clearance, and adjusts the insulin dose based on residual insulin from previous doses. The improvement in hypoglycemia incidence is highly significant.