Bionic Pancreas for Type 1 Diabetes Found Feasible to Implement in Primary Care

©sakramir/AdobeStock

Adults with type 1 diabetes (T1D) who started treatment with a bionic pancreas at a primary care site experienced similar glycemic benefits as those initiating the device through an endocrinologist, according to a study published in Clinical Diabetes.

In the small study, investigators observed that 97% of all adults achieved an average glucose (AG) of less than 183 mg/dL at 2 weeks with use of the iLet Bionic Pancreas automated insulin delivery (AID) system (Beta Bionics) and 64% had an AG of less than 154 mg/dL, with no differences in glucose levels between those attending primary care compared to an endocrinologist, and no differences between telehealth and in-person device initiation.

“The iLet Bionic Pancreas (BP) system was previously studied only in diabetes subspecialty centers, although half of adults with type 1 diabetes receive care from primary care providers (PCPs),” corresponding author Sean M. Oser, MD, MPH, an associate professor of family medicine and associate director of the primary care diabetes lab at University of Colorado Anschutz Medical Campus, and colleagues wrote. “The BP is the first automated insulin delivery system that fully automates dosing and titration, improving diabetes management for people with diabetes and their care providers.”

Oser and colleagues conducted an open-label, random-order crossover trial to compare use of the iLet BP system with usual care (UC) over 4 weeks in adults with T1D across 2 sites: a primary care site and an endocrinology center, with half of each site’s participants completing study procedures via telehealth. They enrolled 40 adults aged 18 to 85 years with T1D, an HbA_1c of less than 11, and an estimated glomerular filtration rate of 30 mL/min/1.73 m² or higher (mean age, 44.8 years; 43% women). Participants were randomly assigned to 2 weeks of the bionic pancreas automated insulin delivery system or 2 weeks of UC. Adults crossed over to the opposite group at 2 weeks. The primary outcome was the proportion of adults achieving a CGM average glucose of less than 183 mg/dL, with the key secondary outcome being the percentage of participants achieving an average glucose of less than 154 mg/dL.

Findings

At 2 weeks, 97% of participants had an AG of less than 183 mg/dL and 64% had an AG of less than 154 mg/dL. No significant differences in the percentage of adults achieving the average glucose goals were observed between primary care and endocrinologist care, or between in-person care and telehealth.

Adults in the primary care group had greater improvements in time below range of less than 70 mg/dL (P = .002), time below range of less than 54 mg/dL (P = .04), and coefficient of variation (P = .015) with bionic pancreas use than adults receiving care from an endocrinologist. Total daily insulin dose did not change with the bionic pancreas for any subgroup. No changes were observed in diabetes distress, hypoglycemia confidence, diabetes technology attitudes, and fear of hypoglycemia between usual care and the bionic pancreas.

No diabetic ketoacidosis events, deaths, or severe adverse device effects were reported. Four adults receiving care from an endocrinologist had an infusion set failure compared with none of the primary care group, whereas 4 adults attending primary care had a cartridge issue with the bionic pancreas compared with no participants in the endocrinologist group.

“These findings suggest that this device, with its uniquely simplified initialization and use, may expand access to AID technology to more patients who otherwise may be limited by geography and/or access limitations to subspecialty care,” the research team concluded. “Larger studies of longer duration are needed across a more diverse population to understand how PC and/or TH deployment of the BP may help to reduce barriers and improve access to diabetes technology.”

Reference: Oser SM, Putman MS, Russell SJ, et al. Assessing the iLet Bionic Pancreas Deployed in Primary Care and via Telehealth: A Randomized Clinical Trial. Clin Diabetes. Published online February 24, 2025. doi:10.2337/cd24-0104