FDA Grants Clearance to iLet Bionic Pancreas

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Announced by the US FDA on May 19, 2023, the clearance of the iLet ACE Pump and the iLet Dosing Decision Software, when combined with a compatible CGM, will form the iLet Bionic Pancreas.

FDA logo in black over a white background | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has announced the clearance of the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people aged 6 years or older with type 1 diabetes.

Announced on May 19, 2023, the clearance of the 2 devices, when combined with a compatible FDA-cleared integrated continuous glucose monitor, will form the iLet Bionic Pancreas and usher in a new age of glycemic control.1

“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 Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.1 “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.”

With approval coming through the 510(k) premarket clearance pathway, the long-awaited iLet Bionic Pancreas can soon become a reality for people with type 1 diabetes. With an adaptive closed-loop algorithm requiring only a users body weight for start-up and removing the need to manually adjust insulin pump settings, the iLet Bionic Pancreas represents a significant leap forward for insulin users.1

Born out of co-founder Ed Damiano’s experience raising his own son with type 1 diabetes, the clearance allows the technology from Beta Bionics brings to reality an idea many within the community have had for decades: a bionic pancreas.2 Examined in the Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT), which enrolled 440 patients with type 1 diabetes, the iLet Bionic Pancreas boasts clinical trial data demonstrating use was associated with a 0.5% reduction in HbA1c at the end of the 13-week study period compared to standard care, with iLet users also experiencing a mean increase in time in target range of 2.6 hours per day.3

At the American Diabetes Association 2022 Scientific Sessions, Beta Bionics presented further data elucidating the potential benefits of the iLet Bionic Pancreas. In these presentations, which examined the effects in different age-based subgroups, results suggested use of the bionic pancreas was associated with reductions in mean HbA1c across populations regardless of race, education, or income level in IO BPPT.4

In addition to the aforementioned features and benefits, the iLet device was created with the intent of simplifying use at mealtime by replacing carb c counting with a new meal announcement feature that will allow users to estimate cards in their meal as small, medium, or large. According to the FDA, the system will adapt over time to respond to the users’ individual insulin needs. With the iLet Dosing Decision Software, the technology is able to independently determine and command increase, decrease, continued maintenance, or suspension of all basal insulin doses.1

In a recent episode of Diabetes Dialogue, our hosts sat down with Steven Russell, MD, chief medical officer of Beta Bionics, to discuss the development of the iLet Bionic Pancreas as well as the future development of the system.
 Check out the preview below and use the link for the full episode:

References:

  1. Commissioner O of the. FDA clears new insulin pump and algorithm-based software to support enhanced automatic insulin delivery. U.S. Food and Drug Administration. May 19, 2023. Accessed May 19, 2023. https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery.
  2. Isaacs D, Bellini N. Diabetes dialogue: The prospect of a bionic pancreas, with Steven Russell, MD, Phd. HCP Live. January 14, 2023. Accessed May 19, 2023. https://www.hcplive.com/view/diabetes-dialogue-the-prospect-of-a-bionic-pancreas-with-steven-russell-md-phd.
  3. Campbell P. Ilet bionic pancreas shows promise in pivotal trial. HCP Live. May 4, 2022. Accessed May 19, 2023. https://www.hcplive.com/view/ilet-bionic-pancreas-shows-promise-in-pivotal-trial.
  4. Howell C. The insulin-only bionic pancreas pivotal trial showed consistent mean hba1c reductions across a variety of subgroups at ADA’s 82nd scientific sessions. BetaBionics. June 9, 2022. Accessed May 19, 2023. https://www.betabionics.com/the-insulin-only-bionic-pancreas-pivotal-trial-showed-consistent-mean-hba1c-reductions-across-a-variety-of-subgroups-at-adas-82nd-scientific-sessions/.

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