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In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sit down with Steven Russell, MD, PhD, Chief Medical Officer at Beta Bionics, to discuss the latest real-world outcomes from the iLet Bionic Pancreas—an autonomous insulin delivery (AID) system cleared by the US Food and Drug Administration (FDA) in 2023.

Russell outlines the iLet’s fully automated design, which sets it apart from conventional AID systems by requiring no manual settings, carb ratios, or correction factors. The system determines 100% of insulin dosing, adapting continuously to glycemic trends without relying on user engagement. This autonomy makes the iLet particularly effective for individuals with suboptimal diabetes self-management or limited access to endocrinology care.

New real-world data, covering 3,300 users from the first year of commercial rollout, reveal a mean baseline A1c of 8.5%—higher than the 7.8% in the pivotal trial and reflective of the broader U.S. type 1 diabetes (T1D) population. The iLet reduced glucose management indicator to 7.3%, yielding an average A1c reduction of 1.2%, more than double that seen in the pivotal study. Outcomes were most pronounced among those with severe hyperglycemia: users starting with A1c >14% saw average reductions of 7%, with low rates of diabetic ketoacidosis (DKA) and minimal increases in hypoglycemia (median time <70 mg/dL, 1.6%; time <54 mg/dL, <0.3%).

Crucially, the iLet’s performance remains consistent regardless of user engagement. Patients who announced meals more than four times daily experienced only a 0.4% greater GMI improvement compared to those announcing meals once every three days. This supports its use in underserved populations and those with a high diabetes burden. The algorithm also adapted effectively in the presence of prior long-acting insulin, though Russell recommended limiting such adjunct therapy to no more than 50% of estimated basal needs.

Isaacs and Bellini highlighted the clinical significance of the iLet's ability to lower A1c while simultaneously reducing hypoglycemia—a rare achievement in diabetes therapy. The episode also explored the iLet’s off-label use in type 2 diabetes (T2D). While formal trials are ongoing, preliminary data from MDI-treated T2D users suggest similarly favorable outcomes.

A forthcoming trial will test the iLet in primary care settings for both T1D and T2D. Early results from a pilot study found no difference in glycemic outcomes whether training was delivered by endocrinologists or primary care providers, reinforcing the system’s potential to expand access to AID beyond specialty care.

00:00:01 Introduction and Guest Introduction

00:01:12 Early Research and Development

00:02:30 Real World Data Overview

00:26:08 Impact of Islet on A1C and Hypoglycemia

00:26:25 Clinical Considerations and User Engagement

00:27:02 Real-World Data Analysis and Future Studies

00:32:05 Conclusion and Future Prospects