Life-saving artificial pancreas startup considers Colombia for its first-in-human trial

An artificial pancreas under development by an Asheville doctor and his son could save lives, money and time in the hospital. They are considering conducting their human trial in Colombia.

From Citizen-Times, August 29, 2016: An Asheville doctor-and-son team have an idea they say could save at least 100,000 lives a year. Leon and Jeremy DeJournett have patented an artificial pancreas, a system that uses a form of artificial intelligence to ensure patients’ glucose levels don’t get too high or low. 

An Asheville doctor-and-son team have an idea they say could save at least 100,000 lives a year.

Leon and Jeremy DeJournett have patented an artificial pancreas, a system that uses a form of artificial intelligence to ensure patients’ glucose levels don’t get too high or low.

Computer models, animal testing using pigs and an experiment in which Dr. Leon DeJournett used himself as the subject have shown the mechanism, essentially a bedside machine, eliminates the need for nurses and, therefore, reduces the possibility for human error.

“We believe our artificial pancreas can outperform the native system of the pancreas and liver, which also produces glucose, because it’s not physically limited,” said DeJournett, who has been an intensive-care unit pediatrician at Mission Hospital in Asheville for more than two decades.

By “native system,” DeJournett means the one that already exists in the body.

“Our goal is to bring this to intensive care units, where between 75 and 80 percent of patients are not diabetic,” DeJournett said.

Most people think diabetes when the subject of glucose control arises. But applying the artificial-pancreas technology in intensive care units would be critical because the body naturally produces more glucose during times of stress, DeJournett said.

He stepped down from his role of pediatric ICU director earlier this year to devote more time to bringing the artificial pancreas to market through Ideal Medical Technologies, which he founded. He serves as its CEO.

By working in intensive care, DeJournett realized mortality rates could be reduced through better management of blood-sugar amounts and reducing glucose-level fluctuation.

Dr. Leon DeJournett, an intensive-care unit pediatrician at Mission Hospital in Asheville, and his son, Jeremy, have patented an artificial pancreas they say could save at least 100,000 lives a year. (Photo: Angela Wilhelm/awilhelm@citizen-)

Dr. Leon DeJournett, an intensive-care unit pediatrician at Mission Hospital in Asheville, and his son, Jeremy, have patented an artificial pancreas they say could save at least 100,000 lives a year. (Photo: Angela Wilhelm/awilhelm@citizen-)

Dr. Leon DeJournett, an intensive-care unit pediatrician at Mission Hospital in Asheville, and his son, Jeremy, have patented an artificial pancreas they say could save at least 100,000 lives a year. (Photo: Angela Wilhelm/awilhelm@citizen-)

Nursing the load

Nurses must manually test ICU patients to monitor blood-sugar levels, a process sometimes done more than once an hour. Results determine how much insulin patients must receive to keep glucose amounts in the prescribed ranges.

“Evidence shows that good glycemic control is important,” said Linda Fornoff, manager of Mission Health System’s Diabetes Center and a registered nurse.

Mission uses Glucommander, a glucose-management and monitoring system manufactured by Glytec Systems in Greenville, South Carolina.

Removing responsibility from nurses would allow them to focus on more acute hospital situations, said Dr. Jeffrey Joseph, director of the Jefferson Artificial Pancreas Center at Thomas Jefferson University Sidney Kimmel Medical College in Philadelphia.

A recent study Joseph cited concluded nurses spend more than 100 minutes to complete a glucose test and adjust insulin levels for every patient they treat.

“There is a great clinical need for technology to improve the safety and efficiency of glucose control and monitoring in hospitals,” Joseph said.

Dr. Valerie Garrett, Mission’s inpatient diabetes director, said in a statement that she and her colleagues have “been pleased with” Glucommander. It “has led to decreased hyper- and hypo-glycemia for our patients on intravenous insulin” and “has also helped us to reduce the duration of IV insulin.”

But Garrett also said Mission “is excited for the future of technology like closed-loop artificial pancreas systems and the life-changing impact those systems will have for hospitalized people who require insulin treatment.”

The DeJournetts' artificial pancreas would differ from others in a few key aspects.

First, their glucose-management system uses artificial intelligence, while the others use standard engineering approaches.

Second, almost all other comparable systems have focused on treating those suffering from Type 1 diabetes. The DeJournetts are concentrating on ICU patients.

But modifications would enable their device to also treat diabetics.

That type of artificial pancreas – something researchers have been attempting to create for about half a century – would be “revolutionary," Joseph said.

He cofounded a glucose-sensor startup company in 1994 that is now the diabetes division of Johnson & Johnson, the New Jersey-based multinational company that specializes in medical devices, pharmaceutical and consumer-packaged products.

“The 1 million people with Type 1 diabetes, who make no insulin, will be released from the burden of managing their disease as often and be able to live more normal lives,” Joseph said.

A family affair

While DeJournett supplies the clinical and medical know-how for the project, his son, Jeremy, 22, is the man with the tech plan.

He is Ideal Medical Technologies' chief technology officer and just returned to his undergraduate studies at the University of Illinois at Urbana-Champaign after taking three semesters off to create the artificial pancreas software.

The DeJournetts worked together on the software code. Dr. DeJournett wrote the code, and Jeremy implemented it. They used control theory to develop the software.

Control theory is the study of how to modify a system’s inputs to achieve a desired output. For example, to make a canoe turn right, one has to paddle on the left side. In the case of glucose control, dextrose may be used to raise the glucose level and insulin may be used to lower it.

“If we understand the factors affecting the glucose level, we can control it,” Jeremy DeJournett said.

“We had to figure out the (glucose) interplay of the pancreas and liver and link that to the software using sensors,” he said.

Domestic v. international costs

Federal officials awarded a patent for the technology in April last year. The European Patent Office awarded one in March 2016.

Angel investors then granted the DeJournetts about $100,000 last August to conduct testing on pigs. Results of those trials showed their concept would work.

Before that funding, Dr. DeJournett had spent about $200,000 on obtaining the patents for the concept.

Dr. DeJournett also tested himself using the software program by eating a 2,400-calorie meal from McDonald’s, then observing how the system would adjust his glucose amounts.

That trial also proved successful.

The next step is to raise $5 million that would enable the construction of an artificial pancreas prototype and conduct initial, small-scale human trials.

Trials at Mission is a possibility, Jeremy DeJournett said. But they might occur overseas, instead, where costs are lower.
One location could be Colombia.

“Several research centers have quickly shown interest in accompanying Dr. DeJournett as co-researchers following the research on this very promising method,” Dr. Miguel Botero Montaño said in an email from Bogota, where he is based.

Botero is business development director for Interventional Concepts Inc., a clinical research organization in Miami, Florida.

The DeJournetts’ artificial pancreas automatically would operate “either insulin or glucose infusion pumps to avoid variations that may endanger the patient,” Botero said.

An artificial pancreas would allow real-time adjustments to glucose levels and reduce “the risk of cardiovascular and metabolic complications in ‘fragile’ conditions or elderly patients,” he said.

Julio G. Martinez-Clark, Interventional Concepts president and CEO, said from Miami that his company is trying to connect the DeJournetts with a Colombia principal investigator and research site.

There they “can get the clinical data that (they need) to show safety and efficacy of his product” prior to U.S. Food and Drug Administration approval.

Joseph said that practice of going international for initial trials has become more common in medicine, particularly as costs have risen and budgets have become tighter.

It’s no longer enough to show a new treatment will work or improve patient health, he said. Researchers must show their ideas will reduce healthcare costs, too.

With 6 million U.S. ICU patients annually and 80,000 intensive-care hospital beds throughout the country, Dr. DeJournett believes the potential for savings is vast.

“This could double profit margins of ICUs,” where hospitals generate about 15 percent of their revenue, he said.

Dr. DeJournett projects the artificial pancreas would yield a net savings of $1,500 per patient. Plus, fewer complications would occur and hospital ICU stays could drop to an average of three days from an average of four days, he said.

It costs $2,000 to $3,000 per day to stay at a hospital, Dr. DeJournett said.

Joseph, the Philadelphia-based artificial-pancreas expert, agrees.

“I’m a firm believer that, yes, an artificial pancreas will reduce costs, but a study hasn’t been done,” Joseph said. “You need to prove it in a trial.”

Arriving at the hospital

Dr. DeJournett said the earliest his technology could be on the market would be three years. A large-scale human trial must be done to gain FDA approval, and a company must agree to manufacture the artificial pancreas.

That work could cost about $60 million, Dr. DeJournett said.

Other companies also are working on this technology, Joseph said.

So, there’s no guarantee the DeJournetts would be first.

A 2001 study of glucose control in critically ill patients brought the issue to fore of the general medical community, Jeremy DeJournett said.

“It’s essentially been a race since then,” Dr. DeJournett said.

Jeremy DeJournett, left, and his father, Dr. Leon DeJournett, working together. The two have teamed up in an effort to develop an artificial pancreas. (Photo: Courtesy of Jeremy DeJournett)

Jeremy DeJournett, left, and his father, Dr. Leon DeJournett, working together. The two have teamed up in an effort to develop an artificial pancreas. (Photo: Courtesy of Jeremy DeJournett)