NCT05815342

OP5-005 Using Omnipod 5 in Adults With Type 2

Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Detailed description

This outpatient study consists of 2 phases. Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information. Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DEVICE	Omnipod 5 Automated Glucose Control System	The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Timeline

• Start date: 2023-04-11
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-04-18
• Last updated: 2025-09-29
• Results posted: 2025-09-29

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study