The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software.
FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an algorithm, the automated insulin delivery system determines and commands insulin delivery.
iLet currently pairs with the Dexcom G6 CGM.
“Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes through precision medicine approaches.”
How the Beta Bionics iLet Bionic Pancreas works
The Beta Bionics iLet Bionic Pancreas uses an adaptive, closed-loop algorithm. It initializes only with a user’s body weight and requires no additional insulin dosing parameters. The algorithm removes the need to manually adjust insulin pump therapy settings and variables.
iLet also simplifies mealtime use by replacing conventional carb counting with a new meal announcement feature. This feature enables users to estimate the amount of carbs in their meal as “small,” “medium” or “large.” Over time, the algorithm learns to respond to users’ individual insulin needs.
The iLet dosing decision software determines and commands the increase, decrease, maintenance or suspension of basal insulin doses. It commands correction doses of insulin based on the input from an iCGM. The software also independently determines and commands meal doses of insulin based on the meal announcement feature.
Last year, the company reported that a trial of its iLet Bionic Pancreas met key endpoints, including reduced HbA1c. Endpoints included consistently demonstrating reduced mean HbA1c across populations regardless of race, education, or income level in exploratory analyses of subpopulations.
Adult users of the iLet Bionic Pancreas experienced a reduction in diabetes distress and fear of hypoglycemia. They demonstrated statistically significant differences relative to the standard of care group.
Beta Bionics officials offer their views
In a news release issued on Monday, May 22, Beta Bionics said it designed the iLet to alleviate the work of diabetes management in everyday life. The company also seeks to nearly eliminate the expertise required to set up and manage a traditional insulin pump.
Beta Bionics says it enables healthcare providers to spend less time with the technology and more with their patient. Sean Saint, president and CEO, says iLet “changes the paradigm of diabetes management” as the first fully automated insulin dosing system.
“This company has worked tirelessly over the past seven years to bring the first Bionic Pancreas to market. And now the iLet is here, ready to be prescribed to the T1D community and will ship imminently,” said Saint. “We hope that, for many people, the iLet helps to make diabetes a little bit easier.”
Dr. Steven Russell, chief medical officer, said the degree of automation offered by iLet relieves healthcare providers from the burden of reviewing blood glucose and CGM data in order to adjust pump settings.
Founder and executive chair Ed Damiano said clearance marks a mission more than two decades in the making. Over 23 years ago, his son first developed diabetes, leading Damiano to found the company and build the iLet platform.
“From that day, I drew motivation from him and dreamt of automating our tireless care for him so that he could have a long, healthy, and less encumbered life,” Damiano said. “Today we celebrate the dream that the iLet now fulfills. As we begin our commercial efforts to bring the iLet to the T1D community, we will continue our ongoing work on the bihormonal bionic pancreas so that we may one day deliver upon the promise that our next technology holds.”
This story was updated on May 22 with additional information from Beta Bionics.
