NCT06865989

Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.

Conditions

• Diabetes Mellitus, Type 1, Type 2

Interventions

Type	Name	Description
DEVICE	Omnipod 5 SmartAdjust 2.0 System	Omnipod 5 System with changes
DEVICE	Omnipod 5 System	Cleared device as comparator

Timeline

• Start date: 2025-03-26
• Primary completion: 2025-11-10
• Completion: 2025-11-10
• First posted: 2025-03-10
• Last updated: 2025-12-18

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study