Omnipod 5 System for Type 1 Diabetes

This trial aims to test the Omnipod 5 System, a new insulin pump for people with type 1 diabetes. Participants will either use the Omnipod 5 or continue with their current insulin pump. The goal is to compare how well the Omnipod 5 manages blood sugar levels against current pumps. This trial suits individuals with type 1 diabetes who have used an insulin pump for at least three months and are familiar with managing their insulin. As an unphased trial, participants contribute to valuable research that may enhance diabetes management tools.

The trial does not specify if you need to stop taking your current medications, but you must be on a steady dose of metformin if you are taking it. You cannot be on non-insulin diabetes medications other than metformin, and you should not be on systemic steroids during the study.

Research has shown that the Omnipod 5 System is generally safe for people with type 1 diabetes. Studies found that users of this system achieved better blood sugar control and experienced fewer instances of low blood sugar, or hypoglycemia. This indicates that the system is usually well-tolerated. However, individuals taking hydroxyurea, a medication for conditions such as cancer and sickle cell anemia, should avoid using the Omnipod 5 System. Overall, evidence suggests that this automated insulin delivery system is safe when used as directed.¹²³⁴⁵

The Omnipod 5 System is unique because it integrates an advanced insulin pump with the Dexcom G6 continuous glucose monitoring system, allowing for seamless, automated insulin delivery. Unlike traditional insulin pumps that require manual adjustments, this system automatically adjusts insulin based on real-time glucose readings, offering a more hands-off approach for managing Type 1 Diabetes. Researchers are excited about this treatment because it has the potential to improve glucose control and reduce the burden of diabetes management, making daily life easier for patients.

Research has shown that the Omnipod 5 System can greatly improve blood sugar control for people with type 1 diabetes. In a study of 37,640 users, those using the system maintained their blood sugar within the target range about 68.8% of the time. Another study found that users of Omnipod 5 reduced their HbA1c levels (which measure average blood sugar over time) by an average of 0.8% compared to those using traditional insulin injections. This trial will compare the Omnipod 5 System, used in the intervention arm, with participants' current insulin pumps in the control arm. The Omnipod 5 System automatically delivers insulin, stabilizing blood sugar levels more effectively than manual methods. Overall, these findings suggest that the Omnipod 5 System could help users manage their diabetes better.⁶⁷⁸⁹¹⁰