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

Area of Science:

• Endocrinology
• Pediatric Diabetes Management
• Medical Device Technology

Background:

• Hybrid closed-loop (HCL) systems integrate continuous glucose monitoring (CGM) and insulin pumps for automated insulin delivery.
• Evaluating real-world effectiveness of HCL systems is crucial for optimizing type 1 diabetes (T1D) management in pediatric populations.

Purpose of the Study:

• To assess the efficacy of the Omnipod5 HCL system in improving glycemic control in children and young people (CYP) with T1D.
• To evaluate changes in HbA1c, time-in-range (TIR), hypoglycemia, and glucose variability over 3 and 6 months.

Main Methods:

• A real-world study involving 144 CYP (under 18) with T1D initiated on the Omnipod5 system.
• Collected HbA1c and CGM metrics (TIR, TAR, TBR, CV) at baseline and 3/6 months post-initiation.
• Compared outcomes between baseline and post-initiation periods.

Main Results:

• Significant HbA1c reduction from 7.7% to 7.1% at 3 months and 7.2% at 6 months.
• TIR improved from 53.3% to 67.4% (3 months) and 68.8% (6 months).
• Observed reductions in time above range (TAR), time below range (TBR), and glucose variability (CV).

Conclusions:

• The Omnipod5 HCL system demonstrates safety and effectiveness in improving glycemic control for CYP with T1D in an NHS setting.
• Real-world data supports the benefits of this tubeless HCL system for pediatric diabetes care.
• Further research on long-term outcomes and cost-effectiveness is warranted.