The critical care unit is one of the most high-tech places in any hospital, outfitted with state-of-the-art medical equipment to quickly handle most medical issues. Despite this, nurses still manually analyze blood samples and adjust insulin infusion rates of patients. This multi-step process, which can consume a large amount of time of the nursing staff, could in theory be performed perfectly by a machine.
This challenge inspired father-and-son duo Tim and Jeff Valk to launch Admetsys, a company focused on creating an artificial pancreas glucose control system designed specifically for hospital and surgical care. The Admetsys system is a dual-hormone automated glucose control system that would automatically adjust insulin and glucagon delivery based on glucose levels. According to Jeff Valk, who serves as CEO of Admetsys, the company’s product fills a special niche among automated glucose control systems by being designed to be part of hospital infrastructure.
The duo’s journey started over a decade ago when Tim Valk, a practicing endocrinologist in Orlando, Fla, received a 3 a.m. phone call from one of his nurses. She lamented that too much staff time was being squandered on the tedious task of patient blood sugar management.
“Why don’t you fix this?” the nurse demanded, before abruptly hanging up.
Instead of feeling chastised, Dr. Valk was inspired. He called Jeff, an engineer and self-described computer “geek”, and asked if an artificial pancreas at the bedside would even be possible; Jeff believed it was. They teamed up with Glenn Robertelli, a medical device expert who previously worked at Johnson & Johnson, and the trio soon launched Admetsys. A decade later, their quest to bring this system to market is making progress.
It was the promise of what a system could mean for healthcare, identified early on by T1D Exchange and its partners, that helped Admetsys win second place in the inaugural Diabetes Innovation Challenge, hosted by T1D Exchange in 2016. The challenge was the first competition dedicated to finding novel innovations for all aspects of diabetes research, clinical care, and patient quality of life.
“The event hadn’t been done before,” says Jeff Valk. “But the people who were there had a heck of a lot more commitment than you usually see in events like this.”
The Diabetes Innovation Challenge marked the beginning of Admetsys’ relationship with T1D Exchange, which subsequently invested in the company. (T1D Exchange publishes T1D Exchange Glu.)
With the Admetsys system, a tiny laboratory-on-a-chip gets embedded within each patient’s IV line. Every five minutes, that tiny device measures glucose levels, sending the data to a bedside monitor. From there, an algorithm determines how much glucose or insulin a patient needs to maintain glycemic control, and the patient’s medication levels are adjusted automatically. In this closed-loop glucose control system, a nurse never once has to visit the bedside to adjust medication. Moreover, Admetsys designed a user-interface that allows nurses to call up each patient’s profile locally or remotely on any screen.
“It is a single, elegant piece of hardware that mounts on a rail system or an IV pole,” says Valk. “We literally give the hospitals a solution-in-a-box for automated glucose control.”
Admetsys has already tested this device in three clinical research studies in consultation with the Food and Drug Administration (FDA). The results are encouraging: Admetsys found that, on average, it took the system 2.5 hours to achieve normal glycemic control once the system is initiated. Also, trial results found the system helped achieve glucose control (between 80 mg/dL and 125 mg/dL) in just under 97 percent of patients, and there were zero incidences of hypoglycemia in the trials. Data from the first two clinical trials is expected to be published within the next few months, and the third trial’s results have been submitted as an abstract for an upcoming 79th American Diabetes Association Scientific Sessions.
The company is currently planning a pivotal U.S.-based trial that will be instrumental for going before the FDA for approval, as well as another study in Denmark to support the case for approval in Europe.
To read more about the potential of the Admetsys system to improve outcomes for people with diabetes in hospital setting, click here.