NCT06547918

SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes

Safety and Effectiveness of the Omnipod® 5 SmartAdjust 2.0 System in Individuals With Type 1 and Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals aged 2-70 years with type 1 or type 2 diabetes.

Detailed description

This is a single-arm study that will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes in order to have a minimum of 48 participants (24 with Type 1 Diabetes and 24 with Type 2 Diabetes) initiate the use of the Omnipod 5 SA2.0 System. The Study will take part in two periods. Participants who do not have the minimum requirement of CGM data will undergo 2 weeks of Standard Therapy while using a Dexcom G6 in an outpatient setting before proceeding to Period 1. During period 1, all participants will use the Omnipod SmartAdjust 2.0 System in an outpatient setting for up to six weeks. Period 2 is an optional extension of time that allows participants to continue using the Omnipod 2.0 SmartAdjust System for an additional six months.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Omnipod 5 SA2.0 System	The Omnipod 5 SA2.0 System provides automated insulin delivery based on Continuous Glucose Monitoring (CGM) values.

Timeline

• Start date: 2024-07-18
• Primary completion: 2025-09-08
• Completion: 2025-09-08
• First posted: 2024-08-09
• Last updated: 2026-01-22

Locations

2 sites across 1 country: New Zealand

Regulatory

• FDA-regulated device study