Trial results for a study evaluating the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor in children and adults with Type 1 Diabetes were posted on 2026-04-14. The intervention group demonstrated a mean Time in Range (70-180 mg/dL) of 65.26%, significantly higher than the control group's 43.01%, and achieved a mean HbA1c of 7.20% compared to the control group's 8.00%.
Background
Type 1 diabetes is an autoimmune condition where the body's immune system attacks and destroys the insulin-producing beta cells in the pancreas, leading to a lifelong dependence on external insulin. Managing type 1 diabetes requires careful monitoring of blood glucose levels and precise insulin delivery to prevent both hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar), which can lead to serious short-term and long-term complications. Traditional management often involves multiple daily injections (MDI) of insulin and frequent self-monitoring of blood glucose or the use of continuous glucose monitors (CGMs). Automated insulin delivery (AID) systems, such as the Omnipod 5, integrate insulin pumps with CGMs to automatically adjust insulin delivery, aiming to improve glycemic control and reduce the burden of diabetes management for patients.
Trial design
This completed study, identified as Phase NA, enrolled 189 participants with Diabetes Mellitus, Type 1. The trial was designed as a randomized, controlled study to assess the efficacy and safety of the Omnipod® 5 System, which integrates with the FreeStyle Libre 2 continuous glucose monitor. This intervention was compared against a control arm using Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor. The study aimed to evaluate improvements in glycemic control parameters.
Key results
The trial results highlighted significant improvements in key glycemic metrics for participants using the Omnipod® 5 System:
- At baseline, the mean HbA1c for the Intervention Group was 8.13% (Standard Deviation 0.70), and for the Control Group, it was 8.10% (Standard Deviation 0.59). At the study's conclusion, the Intervention Group achieved a mean HbA1c of 7.20% (Standard Deviation 0.60), while the Control Group's mean HbA1c was 8.00% (Standard Deviation 0.73).
- Regarding Time in Range (70-180 mg/dL), the Intervention Group's mean percentage improved from 39.42% (Standard Deviation 11.75) to 65.26% (Standard Deviation 7.56). The Control Group's mean percentage changed from 40.85% (Standard Deviation 13.16) to 43.01% (Standard Deviation 10.99).
- For Time <54 mg/dL, the Intervention Group's mean percentage was 0.49% (Standard Deviation 0.52) at the end of the study, compared to 0.61% (Standard Deviation 1.49) at baseline. The Control Group's mean percentage was 0.63% (Standard Deviation 1.03) at the end of the study, compared to 0.95% (Standard Deviation 2.23) at baseline.
What this means
The posted results indicate that the Omnipod® 5 System, when used with the FreeStyle Libre 2 CGM, offers a substantial advantage in managing type 1 diabetes compared to multiple daily injections. The significant improvement in Time in Range, from approximately 40% to over 65%, suggests better overall glucose control and potentially reduced risk of diabetes-related complications. The reduction in HbA1c to 7.20% in the intervention group further supports improved long-term glycemic management. These findings suggest that integrated automated insulin delivery systems can empower individuals with type 1 diabetes to achieve more stable glucose levels with a lower incidence of severe hypoglycemia, thereby enhancing their quality of life and health outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05923827, titled "Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults", were posted on 2026-04-14 on clinicaltrials.gov.