Beta receives FDA go-ahead for home trials of AI-guided bionic pancreas

Beta Bionics received FDA approval to begin home-use clinical studies of an autonomous bionic pancreas that employs artificial intelligence to vary hormone doses in adults and children with Type 1 diabetes.

The company’s iLet device, a dual-chamber infusion pump that mimics a biological pancreas, can deliver insulin, glucagon or a combination. The system includes algorithms driven by machine learning to calculate and adapt dose delivery as needed, based on body weight and data from a continuous glucose monitor developed by Dexcom.

The multi-arm, crossover trial will test an insulin-only configuration of the system using Novo Nordisk’s recently approved, fast-acting Fiasp in adults with T1D as well as insulin lispro and conventional insulin aspart in both adults and children.

Adult patients will be recruited by Massachusetts General Hospital and Stanford University, while children 6 to 17 years old will be enrolled through Stanford, Nemours Children’s Health System and the Barbara Davis Center for Diabetes at the University of Colorado.

Boston-based Beta Bionics plans to enter pivotal trials with its final design in 2019 and expects to launch its first product in 2020.

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“This trial is exciting not only because it represents the first time we will be able to test our bionic pancreas algorithms with our own proprietary iLet platform, and not only because it will include both children and adults with T1D, and not only because it will draw upon those who use [multiple dose injection] therapy in equal number to those who use insulin pumps for their usual care, but also because we will be breaking new ground by being the first group to test autonomous insulin delivery using Fiasp,” said principal investigator Ed Damiano, founder and CEO of Beta Bionics and professor of biomedical engineering at Boston University.

“The iLet Bionic Pancreas System trial is a concrete example of patient-centered innovation, and it is ultimately through innovation and research that we’ll defeat diabetes,” Stephen Gough, Novo Nordisk’s global chief medical officer, said in a statement (PDF).

Novo Nordisk has invested in the startup and has partnered with it to carry out several co-development activities. Eli Lilly and Zealand Pharma are also investors and development partners. Zealand’s collaboration, launched in 2016, involves the company’s stable liquid glucagon analog ZP4207.

In January, Beta Bionics launched plans for a $25 million financing round, securing the first $2.5 million from a group of 11 investors six months after midphase data of its diabetes device in addition to proceeds from a previous crowdfunding campaign.