Abstract

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 in an outpatient setting.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 hours at each of three pre-specified glucose targets (130, 140 and 150mg/dL, nine days total) then five days with free choice of glucose targets (110-150mg/dL) using the Omnipod 5. Remote safety monitoring alerts were enabled during the HCL phase. Primary endpoints were difference in time in range (TIR) (70-180mg/dL) between ST and HCL phases and proportion of participants reporting serious device-related adverse events.Mean TIR was significantly higher among children in the free-choice period overall (64.9 ± 12.2%, p<0.01) and when using a 110mg/dL target (71.2 ± 10.2%, p<0.01), a 130mg/dL target (61.5 ± 7.7%, p<0.01), and a 140mg/dL target (64.8 ± 11.6%, p<0.01), and among adults using a 130mg/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.The Omnipod 5 System was safe and effective when used at glucose targets from 110 to 150mg/dL for 14 days at home in children and adults with type 1 diabetes.

View details for DOI 10.1089/dia.2020.0546

View details for PubMedID 33325779