Beta Bionics Inc. is a medical technology company that has developed the world’s first fully automated bionic pancreas and is aiming to commercialize it within the coming years. It recently announced that its iLet Bionic Pancreas System received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
The iLet is a revolutionary bionic pancreas that is driven by mathematical dosing algorithms. The algorithms incorporate lifelong autonomous learning of its users to control their glycemia automatically. It is a pocket-sized, wearable investigational medical device that controls a person’s blood-sugar levels on its own.
The on-body wear is an integrational system that controls blood-sugar levels automatically once the user has entered their body weight into the device. It works as an insulin pump, but the user doesn’t have to worry about setting insulin delivery rates, counting carbohydrates, or delivering bolus insulin for corrections or meals.
The iLet does it all. It has been created to function as three medical devices in one. It can be configured as a glucagon-only bionic pancreas, an insulin-only bionic pancreas, or a bihormonal bionic pancreas using insulin and glucagon. For people with diabetes, the insulin-only and bihormonal configurations could be helpful. While for rare conditions that often lead to chronic, low blood-sugar conditions – such as congenital hyperinsulinism (CHI) – the glucagon-only setting could be beneficial.
Ed Damiano, CEO and President of Beta Bionics said:
We believe the iLet Bionics Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes. We are particularly excited by the possibility that the iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.
A multicenter randomized clinical trial of the iLet was conducted to evaluate its effectiveness. The results revealed that the new system is more effective at controlling blood glucose levels in people with type 1 diabetes than current treatments. The system improved the participants’ blood glucose controls 24 hours. Overnight monitoring is usually a severe challenge for anyone with type 1 diabetes since blood glucose can fall to dangerously low levels when a person is sleeping. The research has been published in the New England Journal of Medicine.
Boris Kovatchev, Ph.D., director of the UVA Center for Diabetes Technology, said:
This artificial pancreas system has several unique features that improve glucose control beyond what is achievable using traditional methods. In particular, there is a special safety module dedicated to the prevention of hypoglycemia, and there is gradually intensified control overnight to achieve near-normal blood sugar levels every morning.
The iLet offers people the ability to improve glycemic control. It also eases the daily burden of blood sugar management so they can have a better, less stressful life. It is not available yet, but Beta Bionics is fully dedicated to making the system available to all who need one as soon as possible.
