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Diabetes Dialogue: Bionic Pancreas Brings AID to Primary Care & Telehealth
In this episode, hosts discuss a study assessing the benefit and feasibility of AID for type 1 diabetes with the iLet Bionic Pancreas in different settings.
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!
New research underlines the feasibility of telehealth- and primary care-led initiation of automated insulin delivery (AID) among patients with type 1 diabetes.
A multisite, random-order crossover trial of 40 adults with type 1 diabetes, study results suggest 97% of participants achieved a mean glucose less than 8% (183 mg/dL) and 64% achieved a mean glucose less than 7% (154 mg/dL) when using the iLet Bionic Pancreas.
“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," wrote investigators.
A clinical trial led by Sean Oser, MD, MPH, and Tamara Oser, MD, and conducted between March 2022 and May 2023, the study was designed to evaluate the use of the iLet Bionic Pancreas for insulin delivery in individuals with type 1 diabetes across primary care and endocrinology settings, including both in-person and telehealth subgroups.
Per trial protocol, participants completed 2, 14-day study arms in randomized order. One study arm involved use of the iLet Bionic Pancreas and the other required patients to their usual care insulin regimen, which was defined as multiple daily injections with or without continuous glucose monitoring for primary care and automated insulin delivery or insulin pump with or without continuous glucose monitoring for endocrinology.
The primary outcome was the percentage of participants achieving a mean glucose level of less than 183 mg/dL, which is representative of a glucose management indicator of less than 8.0%. The trial’s key secondary outcome included achievement of a mean glucose level of less than 154 mg/dL, which is representative of a glucose management indicator of less than 7.0%).
The 40-patient study cohort had a mean age of 44.8 (SD, 14.0) years, 43% were female, and 85% were White). At baseline, the primary care group had a mean a HbA1c of 6.9% (SD, 0.8%) and the endocrinology group had a mean HbA1c of 7.2% (SD, 0.8%). Of note, a single patient was lost to follow-up as the result of a seizure unrelated to study procedures during the usual care portion and never participated in the intervention arm.
Results of the study suggested 97% of participants achieved a mean glucose level less than 183 mg/dL and 64% reached less than 154 mg/dL. Further analysis of study data revealed no differences in glucose levels among those attending primary care and endocrinology nor were any differences observed between initiation with telehealth and in-person settings (P > .05).
Additionally, investigators pointed out the iLet Bionic Pancreas demonstrated consistent performance across mean glucose levels, time in range, time above 180 mg/dL, time above 250 mg/dL, time below 54 mg/dL, and glucose variability.
In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector 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, take a deep dive into this study and discuss the role of primary care in diabetes technology uptake in type 1 diabetes.
Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.
