MILPITAS, Calif. – Bigfoot Biomedical plans to conduct a clinical trial of its automated insulin delivery system at sites across the U.S. in 2018, and is looking to expand into Europe and China.
The company signed an agreement earlier this year with Abbott to integrate its FreeStyle Libre glucose sensing technology into the automated insulin delivery system, which does not require fingerstick calibration of a glucose sensor.
“Abbott developed the best, most user-friendly, cost-effective, scalable glucose monitoring technology,” said Jeffrey Brewer, president and CEO of Bigfoot Biomedical, in a feature on the Digital Health Today podcast. “We’re going to build a whole product around it.”
Details of the trial have not yet been announced but Brewer said that, pending approval from the U.S. Food and Drug Administration for the system, a commercial launch is planned for 2020.
As Bigfoot Biomedical moves closer to the trial, Brewer said the pieces are in place for the final assembly of two Class III systems: an artificial intelligence-driven system that uses the interface of a smartphone; and a parallel system that will connect to insulin pens to automate injections. The innovation will ultimately benefit patients, health care providers and insurers, as the data gathered from the system proves its effectiveness.
“You’re doing something with the data that will tie it back to health care economic outcomes that are not only going to drive reimbursement decisions, but make the payers active advocates for the penetration of the technology because it actually saves them money,” he said. “That’s the future of health care.”