Bionic pancreas device approved for home-use clinical study in US

The US Food and Drug Administration (FDA) has given permission for a dual-hormone artificial pancreas, dubbed the bionic pancreas, to be used in the homes of people with type 1 diabetes.
It is thought the pioneering iLet device could revolutionise diabetes treatment as it mimics the way a pancreas works, delivering insulin, glucagon or a combination. However, in the trial which has been given approval, the device will deliver just insulin.
The iLet has been developed by Edward Damiano, PhD, president of Boston-based Beta Bionics, who is aiming to have the device fully approved by official bodies in the foreseeable future. He introduced it to the world in 2015, calling it a “bridge to a cure” for type 1 diabetes.
The FDA has now given the go ahead for home-use clinical studies. Children aged 6-17 and adults with type 1 diabetes will be recruited via Massachusetts General Hospital, Stanford University and the University of Colorado.
The study will use Novo Nordisk’s recently approved fast-acting insulin aspart, marketed as Fiasp, as well as insulin lispro (Humalog) and conventional insulin aspart (NovoRapid/NovoLog) in both adults and children. Fiasp is the newest insulin in the group of rapid-acting analogue insulin and has been shown to be quicker-acting than Humalog or NovoRapid.
Edward R. Damiano, founder and CEO of Beta Bionics and a professor of biomedical engineering at Boston University, said: “The design of this ambitious insulin-only bionic pancreas study builds on the foundation of previous studies we have conducted with our clinical collaborators testing our bionic pancreas algorithms with previous investigational platforms.”
The previous studies Dr Damiano is referring to include a 2017 study where the bionic pancreas showed glucagon infusion to be successful in preventing hypos, and another later that year where the device reduced diabetes-related distress.
Dr Damiano added: “This trial is exciting, not only because it represents the first time we will be able to test our bionic pancreas algorithms with our proprietary iLet platform … and not only because it will draw upon those who use [multiple daily injection] therapy in equal number to those who use insulin pumps for their clinical care, but also because we will be breaking new ground by being the first group to test autonomous insulin delivery using Fiasp.”
Beta Bionics hopes to enter pivotal trials with its final design in 2019 and anticipates the iLet to launch in 2020.