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Omnipod5 Real-World Data from the First Pediatric Users' Universal Coverage Under the UK National Health Service
Sze May Ng1,2,3, Zoe Tattersall2, Violet Swain2
1Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.
Insights
The Omnipod5 hybrid closed-loop system significantly improved glycemic control in children with type 1 diabetes, reducing HbA1c and increasing time-in-range. This real-world study confirms its effectiveness in a UK National Health Service setting.
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.
Abstract:
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.
