Diabetes Dialogue: What to Know about the iLet Bionic Pancreas

When the diabetes community looks back at 2023, it may be seen as a watershed year for diabetes technology.

In less than 6 months, the community has seen an onslaught of regulatory approvals clearances, including the Omnipod GO, Medtronic MiniMed 780G System, sensors and readers for FreeStyle Libre 2 and FreeStyle Libre 3, and more, and even practice-changing data are expected at the upcoming American Diabetes Association 83rd Scientific Sessions in June 2023.^1,2,3

One event grabbing headlines in late May is a moment people with diabetes and others using insulin once likened to science fiction: the FDA granted clearance to a “bionic pancreas”.⁴

On May 19, 2023, the FDA announced the clearance of the iLet ACE Pump and the iLet Dosing Decision Software for people aged 6 years or older with type 1 diabetes. When combined with a compatible, FDA-cleared integrated continuous glucose the monitor, the technology, which is marketed by Beta Bionics, form the iLet Bionic Pancreas.⁴

The system itself is the result of founder Ed Damiano’s experience in applied mathematics combined with his desire to improve the lives of people with diabetes, which is driven by his son’s experience with type 1 diabetes. The FDA’s clearances for the Beta Bionics technology were based on data from the 440-patient Insulin-Only Bionic Pancreas Pivotal Trial, which assessed use of the iLet Bionic Pancreas in patients with type 1 diabetes and concluded use was associated with a 0.5% reduction in HbA1c at the end of the 13-week treatment period compared to standard care. Further analysis in the trial suggested use of the bionic pancreas was associated with a mean increase in time in target range of 2.6 hours per day.⁴

As a follow-up to an episode from earlier this year with Beta Bionics's chief medical officer Stephen Russell, MD, and the FDA clearances of the technology that forms the iLet Bionic Pancreas, Diana Isaacs, PharmD, an endocrine clinical pharmacist and coordinator of the Remote Monitoring Program at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sat down in the MJH Life Sciences studio for a special edition recording of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives. In the episode, hosts explore the implications of the clearance, dispel misconceptions surrounding the system, and hypothesize about the future of this technology in people with diabetes.

References

1. Campbell P. Endocrine month in review: March 2023. HCP Live. April 2, 2023. Accessed May 26, 2023. https://www.hcplive.com/view/endocrine-month-in-review-march-2023.
2. Campbell P, Iapoce C. Endocrinology month in Review: April 2023. HCP Live. May 2, 2023. Accessed May 26, 2023. https://www.hcplive.com/view/endocrinology-month-in-review-april-2023.
3. Campbell P. Bi 456906 shows promise, reducing body weight up to 14.9%, in phase 2 trial. HCP Live. May 10, 2023. Accessed May 26, 2023. https://www.hcplive.com/view/bi-456906-shows-promise-reducing-body-weight-in-phase-2-trial.
4. Campbell P. FDA grants clearance to Ilet Bionic pancreas. HCP Live. May 19, 2023. Accessed May 26, 2023. https://www.hcplive.com/view/fda-grants-clearance-to-ilet-bionic-pancreas.

Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.