“The most remarkable finding is that our system, which only requires subject weight and no user-specific (open-loop) dosing parameters to get started, is truly one system for all, providing consistent and effective control in adults and adolescents,” said study investigator Firas El-Khatib, PhD, from the department of biomedical engineering at Boston University in Massachusetts.
The system will change clinical practice by automatically determining and handling all dosing requirements for the user without prior knowledge or initialization, whether it is basal dosing, correction bolus dosing or meal bolus dosing (whenever triggered by the user).
Basically, this new bionic pancreas functions like an automated thermostat. The device automatically monitors blood glucose and delivers insulin or glucagon when needed to keep glucose levels within normal range. The bionic pancreas can also be monitored remotely by the patient’s medical provider or a parent.
“It is the only system being developed that would not require for its initialization any user-specific (open-loop) dosing parameters, such as basal-rate profiles, corrections factors and insulin-to-carbohydrate ratios, which are in any case not determined on the same level of adequacy among different users with variable levels of open-loop control,” Dr. El-Khatib told Endocrinology Advisor.
“Our system kicks off immediately without run-in or warm-up period of initial open-loop control and continually undergoes online learning and adaptation to evolve separately for each user. Thus, it is one universal system indeed, but one that is simultaneously capable of providing personalized treatment to each user, as diabetes treatment inevitably requires.”
Dr. El-Khatib and colleagues predict this system will be approved by the FDA and commercially available by the fall of 2017.
In the next 36 months, endocrinologists can expect the first artificial pancreas systems and control-to-range (CTR) systems to be widely available, according to Aaron Kowalski, PhD, from the JDRF and an expert on this new technology.
Including CTR, there are three types of systems. The other two are a threshold suspend system and a control-to-target (CTT) system.
A CTR system reduces the likelihood of a hyperglycemic event or a hypoglycemic event by adjusting insulin doses when a glucose levels are too high or too low in a patient with diabetes. This type of system still requires a patient to give themselves insulin, though, Dr. Kowalski said.
A threshold suspend device system can temporarily suspend insulin delivery when necessary, but patients still need to be active partners in monitoring their blood sugar levels and administering insulin.
A CTT system sets target glucose levels and tries to maintain these levels continually through a fully automated system and requires little to no interaction with the user.
“With every device we worry about safety, and there is always a little bit of a learning curve, and we have seen that with the sensors that have been on the market for a while,” Dr. Jagasia told Endocrinology Advisor. “However, cost will be a barrier. These devices will be vastly more expensive than just delivering insulin injections.”
The FDA has put out a guidance system for the development of these new devices, and the pathway is simple, according to Kowalski. For this very reason, he thinks these devices will be moving from the scientists’ workbench into the clinic sooner rather than later.
“I am very optimistic. It is technically achievable, and more and more data will be coming out in the next 12 months. It is not a matter of if, it is just a matter of when. I think in the next 3 to 5 years the first control-to-range system will be used in everyday practice,” Kowalski said.
- Phillip M, Battelino T, Atlas E, et al. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013;368:824-833.
- Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014;371:313-325.