NCT05409131

Omnipod 5 System Compared to Pump Therapy

Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system. Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.

Detailed description

This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth. Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system. Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system. Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Omnipod 5 System	Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-09-14
• Completion: 2025-01-10
• First posted: 2022-06-08
• Last updated: 2025-09-16
• Results posted: 2025-02-26

Locations

14 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study