Omnipod5 Real-World Data from the First Pediatric Users' Universal Coverage Under the UK National Health Service.

Background: Hybrid closed-loop (HCL) systems combine continuous glucose monitoring (CGM) with insulin pumps to automate insulin delivery through specific algorithms and user input. This real-world study aimed to evaluate the effectiveness of the Omnipod5 HCL system on HbA1c, time-in-range (TIR), hypoglycemia frequency, and sensor glucose variability over 3 and 6 months in children and young people with type 1 diabetes at two National Health Service (NHS)-funded pediatric diabetes centers in North West England. Methods: Children younger than 18 years in two teaching hospital-based diabetes centers were started on Omnipod5 between August 2023 and January 2024. Sensor glucose metrics and HbA1c were collected within 3 months before Omnipod5 initiation and compared at 3 and 6 months postinitiation. Metrics included % TIR (sensor glucose 70-180 mg/dL), % time above range (TAR) (sensor glucose >180 mg/dL and >250 mg/dL), and % time below range (TBR) (sensor glucose <70 mg/dL mmol/L and <54 mg/dL), with variability assessed by coefficient of variation (CV) and standard deviation (SD). Results: A total of 144 children were included, with 46% males and a mean age of 7.1 years (SD 4.3). The cohort was predominantly White (80%), with diabetes duration averaging 4.4 years (SD 3.9). Before Omnipod5, 54% used multiple daily injections, 41% a nonintegrated pump, and 5% another HCL system. At 3 and 6 months postinitiation, there were significant improvements in HbA1c from 7.7% (60.2 mmol/mol) to 7.1% (54.4 mmol/mol) at 3 months and 7.2% (55.2 mmol/mol) at 6 months. TIR improved from 53.3% at baseline to 67.4% at 3 months and 68.8% at 6 months), and reductions in TAR, TBR, and CV were also observed. Conclusions: These findings highlight the Omnipod5 system's safety and effectiveness in improving glycemic control for children and young people (CYP) with type 1 diabetes in a real-world NHS setting. Further research is needed to explore the long-term benefits and cost-effectiveness of this tubeless HCL system in routine clinical care.