Real-World Evidence: How Omnipod DASH® Insulin Management System Helps Patients Achieve Glycaemic Control

Guest Blogger
Category: Clinical Studies

Understanding real-world evidence and its importance in diabetes management

People living with type 1 diabetes (T1D) manage their condition in everyday settings—school and work, or during exercise, and mealtimes. And because real-life diabetes care can be variable and sometimes messy, healthcare professionals (HCPs) can benefit from data that mirror and more directly translate to the circumstances of routine practice. 

Real-world evidence (RWE) bridges this gap by capturing outcomes observed during standard care, helping HCPs understand how a therapy performs across more diverse populations and situations.

One recent RWE study highlighted the value of tubeless pump therapy with Omnipod DASH in real-world, day-to-day clinical care. The retrospective study, conducted with data from 4,738 T1D patients, evaluated how transitioning to Omnipod DASH impacted glycaemic control. The study participants, both adults and children, had their HbA1c levels measured before and after using Omnipod DASH for 90 days. 

Mechanism of action: how Omnipod DASH helps control blood sugar

Omnipod DASH delivers insulin through a small, tubeless Pod worn for up to 72 hours and programmed wirelessly by a Personal Diabetes Manager (PDM). By providing consistent basal rates, on-demand boluses, and flexible site rotation, the system supports more stable glucose levels and may increase time-in-range for people with T1D.1

Click here for more information about the Omnipod DASH Insulin Management System.

Key findings on HbA1c improvement among users

The primary focus was on HbA1c reduction, a key indicator of long-term blood sugar control. Secondary outcomes included changes in insulin use and self-reported hypoglycaemia events. In this study HbA1c improved significantly with Omnipod DASH use.1 

Significant A1c reduction following 90-days of Omnipod DASH use in adult & paediatric cohorts1,* 

  1. Reduction in HbA1c: across the board, patients using Omnipod DASH experienced an average reduction of 0.9% in their HbA1c levels. Notably, both adult and paediatric users saw similar improvements, with paediatric users reducing their HbA1c from 8.6% to 7.7% and adult users from 8.5% to 7.6%.1
     
  2. Higher reductions for higher baseline HbA1c: patients who started with higher HbA1c levels (≥ 8%) showed the most significant reductions (-0.5% or more, p< 0.0001)1, emphasising the potential benefits of Omnipod DASH for those who have struggled to achieve glycaemic control.1 
     
  3. Improvement regardless of previous therapy: whether patients had previously used multiple daily injections (MDI) or tubed insulin pumps (CSII), transitioning to Omnipod DASH resulted in improved outcomes in adults.1 Previous MDI users with a higher HbA1c baseline (≥ 8%) saw statistically significant improvements in HbA1c (-1%, p<0.0001) when transitioning to Omnipod DASH. Similarly, previous CSII users with a higher HbA1c baseline (≥ 8%) also saw statistically significant improvements in HbA1c (-0.6%, p<0.0001), demonstrating Omnipod DASH’s versatility for various patient types.1 

Analysing the impact on adult vs. paediatric patients

The analysis included 4,738 people with T1D1: 

  • 3,341 adults (≥18 years) 
  • 1,397 children or adolescents (<18 years)

Both age groups achieved a mean HbA1c reduction of 0.9 percentage points1:

  • 8.5% to 7.6% for adults
  • 8.6% to 7.7% for paediatrics

Significant improvements were observed regardless of prior therapy.1

Changes in insulin use after transition to Omnipod DASH

Total daily insulin dose (TDD) remained essentially unchanged in paediatric users but decreased significantly in adults. Among adults, mean TDD fell from 62.3 U/day at baseline to 49.8 U/day after 90 days—a 20% reduction (p<0.0001) suggesting greater insulin efficiency when insulin is delivered via the tubeless Pod.1

Frequency of self-reported hypoglycaemia events

Self-reported hypoglycaemic episodes declined after the switch to Omnipod DASH, suggesting that tubeless insulin delivery with Omnipod DASH may help minimise day-to-day hypoglycaemic episodes for adults and paediatric users. 

Adults reported a drop from 2.9 to 1.3 events per week (−1.6 events; p<0.0001) and paediatric users from 2.8 to 1.5 events per week (−1.3 events; p<0.0001).

Clinical implications of these real-world study findings

These real-world results underscore the importance of considering Omnipod® as part of a comprehensive diabetes management plan. Omnipod DASH offers a tubeless alternative that can be easily integrated into daily lives, supporting glycaemic control in both pediatric and adult patients, without the limitations of MDI or traditional insulin pumps.

Addressing study limitations

There are several limitations of this study that must be recognised. It is retrospective, observational, non-blinded, and non-randomised, introducing potential selection bias. Some outcomes—including the frequency of hypoglycaemia—were self-reported, which may affect accuracy. 

Conclusion: the role of Omnipod DASH® in achieving glycaemic control

Across 4,738 real-world users, Omnipod DASH delivered a mean HbA1c reduction of 0.9 percentage points in both adult and paediatric cohorts. In adults, total daily insulin dose fell by 20% and both age groups reported roughly 50% fewer self-reported hypoglycaemic episodes.1 

Real-world evidence from this study highlights Omnipod DASH as a viable option for improving glycaemic control in both paediatric and adult patients. This offers a data-backed approach for HCPs to improve patient outcomes, particularly for those with higher baseline HbA1c levels or those transitioning from MDI or tubed pumps.

Additional resources for patients and HCPs

HCP FAQs

What HbA1c reduction can patients expect after switching to Omnipod DASH®?

Are outcomes comparable in children, adolescents, and adults?

*Retrospective, observational, real-world study of T1D patients initiating the Omnipod DASH System. Database information was taken from medical records or self-reported if medical records were unavailable. The primary outcome was change in glycated haemoglobin (HbA1c) from baseline (before initiation) to 3 months after initiation. Secondary outcomes included changes in TDD of insulin and self-reported frequency of hypoglycaemic events (<70 mg/dL or <3.9 mmol/L per week). Data were collected from July 2018 to March 2021.1 

1. Aleppo G, DeSalvo DJ, Lauand F, et al. Improvements in Glycemic Outcomes in 4738 Children, Adolescents, and Adults with Type 1 Diabetes Initiating a Tubeless Insulin Management System. Diabetes Ther. 2023;14(3):593-610.

The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for
the management of diabetes mellitus in persons requiring insulin. Additionally, the Omnipod DASH System permits manual entry of readings from blood glucose meters, enabling storage and display of blood glucose measurements. Refer to the Omnipod DASH Insulin Management System User Guide for complete safety information including indications, contraindications, warnings, cautions, and instructions.