The FDA on Monday granted an investigational device exemption to Beta Bionics that will allow the company to begin recruitment for the first home-based studies testing the insulin-only configuration of its bionic pancreas system, according to an industry press release.
The first-of-its-kind study, a multi-arm, crossover clinical trial based in the U.S., will test Novo Nordisk’s fast-acting insulin aspart (Fiasp) with the iLet bionic pancreas system in adults with type 1 diabetes, and insulin lispro and conventional insulin aspart using the iLet in adults and children with type 1 diabetes, according to the release. Researchers will recruit adults with type 1 diabetes through Massachusetts General Hospital and Stanford University, and children aged 6 to 17 years with type 1 diabetes through Nemours Children’s Health System, the Barbara Davis Center for Diabetes at the University of Colorado and Stanford University.
The trial will be the first to use the iLet device, which is capable of dosing only insulin, only glucagon or both hormones as needed.
“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,” Edward R. Damiano, PhD, founder and CEO of Beta Bionics and a professor of biomedical engineering at Boston University, said in the release. “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 include both children and adults with [type 1 diabetes], 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.”
Novo Nordisk, an investor in Beta Bionics, has partnered with the medical technology company to carry out several codevelopment activities. Eli Lilly and Zealand Pharma are also investors and development partners. Dexcom, also a development partner, recently received FDA approval of its G6 continuous glucose monitor under the new interoperable CGM designation (iCGM), allowing it to be incorporated into the future iLet platform.
In data from the first in-home study with the device presented at the 2016 American Diabetes Association Scientific Sessions and reported by Endocrine Today, use of a bionic pancreas was associated with reductions in mean glucose and hypoglycemia compared with conventional insulin pump therapy. Damiano, presenting the findings at the meeting, said the mean reduction in glucose level was 162 mg/dL with the bionic pancreas compared with 141 mg/dL with the insulin pump over 11 days (P < .0001). The bionic pancreas was also associated with greater reductions in time less than 60 mg/dL by CGM (1.9% vs. 0.6%; P < .0001).
An IDE allows testing of an investigational device in a clinical study to collect safety and effectiveness data required to support a premarket approval application to the FDA. Beta Bionics plans to enter pivotal trials with its final iLet design in 2019, and expects to launch its first product in 2020, according to the release. – by Regina Schaffer