Real-World Data: Omnipod® 5 Improved Glycaemic Control

Guest Blogger
Category: Clinical Studies

Real-World Data Supports Omnipod 5 Automated Insulin Delivery System for Improved Glycaemic Outcomes1

Evidence from the 2023 real-world study by Marks BE, et al. highlights the significant impact the Omnipod 5 Automated Insulin Delivery (AID) System can have for diabetes care among children, adolescents, and young adults. The study, conducted across two leading U.S. paediatric diabetes centres, followed 195 young people aged 2–21 with type 1 diabetes over the first 90 days of Omnipod 5 use.

Unlike previous pivotal trials, this research focused on a racially, ethnically, and socioeconomically diverse cohort. The results offer valuable insight into the potential of this tubeless insulin pump to transform daily diabetes care for youth. 

Glycaemic Outcomes Associated with Omnipod 5 Initiation

Primary endpoints: Change in time in range (TIR; 70–180 mg/dL) from baseline to 90 days.

Marked improvements of Time in Range (TIR) were observed shortly after initiation of the Omnipod 5 AID System:

  • TIR increased from 49% to 61% (p<0.001)
    • Notably, TIR improved within the first 9 days of use and stabilized thereafter
  • Greater TIR improvement (median +15%-points) was seen in participants with baseline TIR <60%, compared to a median 5%-point improvement for those already ≥60% (p<0.001) 

Secondary endpoints: Change in HbA1c, CGM metrics (mean glucose, time in hypo/hyperglycaemia), insulin dosing patterns, time in automated mode.

Clinically meaningful improvements in HbA1c through 90 days:

  • HbA1c decreased from 7.5% to 6.9% (p<0.001)
  • Youth with the highest HbA1c at baseline had the greatest improvements in HbA1c at 90 days, independent of factors like age, sex, race, and insurance coverage
     

Key Glycaemic Outcomes – Baseline to 90 Days

Omnipod 5 content for blog post for HCP website, focused on Omnipod 5 Real World Data (Marks RWE) and corresponding LinkedIn post Omnipod 5 content for blog post for HCP website, focused on Omnipod 5 Real World Data (Marks RWE) and corresponding LinkedIn post

Summary of Outcomes:

  • +11% increase in TIR overall
  • -0.5% HbA1c reduction
  • Stable improvements maintained from Day 9 to Day 90
  • Greater TIR and HbA1c improvements observed in youth with poorer baseline control
  • TAR and TBR observed a median change from Day 1 to Day 90 of -10 and -0.2, respectively 

Insulin Usage Trends After Switching to Omnipod 5

Alongside glycaemic improvements, meaningful behavioural shifts in insulin use were recorded:
  • Reduced manual boluses: from 5.1 to 5.0 per day (p=0.01)
  • Slight increase in basal insulin %: from 51% to 53% (p<0.0001)
  • Decrease in carbohydrate entries: from 4.2 to 4.1 per day (p=0.005)
  • High usage of automated mode throughout (95–98%) 

These data demonstrate real-world glycaemic improvements in paediatrics with type 1 diabetes seen as early as 9 days and sustained over the first 90 days of AID initiation, especially in those with higher baseline HbA1c and lower baseline TIR. Marks BE, et al. concludes that supporting access to AID systems, like Omnipod 5, for this population and minority groups with historically disparate glycaemic outcomes may lead to overall improved glycaemic control, longer term outcomes, and healthy equity in the management of type 1 diabetes.

We partner with researchers and centres of excellence worldwide to conduct studies in people with diabetes of various ages. Explore additional data here that highlights clinical outcomes and quality of life in various patient populations.

Frequently Asked Questions about Omnipod 5

Is Omnipod 5 effective for youth with poor glycaemic control?

Does Omnipod 5 help reduce hypoglycaemia and hyperglycaemia?

What is the approved age range for Omnipod 5 use?

How long can each Omnipod 5 Pod be worn?

Which insulins are approved for use in the Omnipod 5 Pods?*

*Insulin availability may vary by region.

Reference:
1. Marks BE, et al. Real-world glycemic outcomes with early Omnipod 5 use in youth with type 1 diabetes. Diabetes Technol Ther. 2023;25(11):782-789. doi:10.1089/dia.2023.0337

The Omnipod 5 Automated Insulin Delivery System is a single hormone insulin delivery system intended to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in persons aged 2 and older requiring insulin. The Omnipod 5 System is intended for single patient use. The Omnipod 5 System is indicated for use with NovoLog®/NovoRapid®, Humalog®, Trurapi®/Truvelog®/Insulin aspart Sanofi®, Kirsty®, and Admelog/Insulin lispro Sanofi U-100 insulin. Refer to the Omnipod® 5 Automated Insulin Delivery System User Guide and www.omnipod.com/safety for complete safety information including indications, contraindications, warnings, cautions, and instructions.