First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes
Gregory P. Forlenza, Bruce A. Buckingham, Sue A. Brown, Bruce W. Bode, Carol J. Levy, Amy Criego, R. Paul Wadwa, Erin Cobry, Robert Slover, Laurel H. Messer, Cari Berget, Susan McCoy, Laya Ekhlaspour, Ryan Kingman, Mary Voelmle, Jennifer Boyd, Grenye O’Malley, Aimee Grieme, Kaisa Kivilaid, Krista Kleve, Bonnie Dumais, Todd Vienneau, Lauren M. Huyett, Joon Bok Lee, JASON B. OCONNOR, Eric Benjamin, Trang T. Ly
Abstract
Background: The objective of this study was to assess the safety and effectiveness of the first commercial configuration of a tubeless automated insulin delivery system, Omnipod ® 5, in children (6–13.9 years) and adults (14–70 years) with type 1 diabetes (T1D) in an outpatient setting. Materials and Methods: This was a single-arm, multicenter, prospective clinical study. Data were collected over a 14-day standard therapy (ST) phase followed by a 14-day hybrid closed-loop (HCL) phase, where participants ( n = 36) spent 72 h at each of three prespecified glucose targets (130, 140, and 150 mg/dL, 9 days total) then 5 days with free choice of glucose targets (110–150 mg/dL) using the Omnipod 5. Remote safety monitoring alerts were enabled during the HCL phase. Primary endpoints were difference in time in range (TIR) (70–180 mg/dL) between ST and HCL phases and proportion of participants reporting serious device-related adverse events. Results: Mean TIR was significantly higher among children in the free-choice period overall (64.9% ± 12.2%, P < 0.01) and when using a 110 mg/dL target (71.2% ± 10.2%, P < 0.01), a 130 mg/dL target (61.5% ± 7.7%, P < 0.01), and a 140 mg/dL target (64.8% ± 11.6%, P < 0.01), and among adults using a 130 mg/dL target (75.1% ± 11.6%, P < 0.05), compared to the ST phase (children: 51.0% ± 13.3% and adults: 65.6% ± 15.7%). There were no serious device-related adverse events reported during the HCL phase, nor were there episodes of severe hypoglycemia or diabetic ketoacidosis. Conclusion: The Omnipod 5 System was safe and effective when used at glucose targets from 110 to 150 mg/dL for 14 days at home in children and adults with T1D.