NCT07039981

Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy of a next generation automated insulin delivery algorithm in adults with type 2 diabetes aged 16-70 years old

Detailed description

This study is a single-arm, multi-center, interventional clinical study that will enroll a maximum of 48 adult participants with a goal of 24 initiating the use of the Omnipod M System. It will consist of two phases, Phase 1 will include 2-weeks of Standard Therapy followed by at least 2-weeks of SmartAdjust 2.0 System use. In Phase 2, participants will begin use on the Omnipod M System where multiple iterations of the next-generation algorithm may be tested as needed to optimize algorithm safety and efficacy. Participants aged 16-70 years (inclusive) with type 2 diabetes who participated in the Insulet sponsored SmartAdjust 2.0 Feasibility Study (protocol reference #2024 FULL 20405) or new participants who are currently using an insulin pump or basal-bolus, pre-mix, or basal only users will be recruited for the study.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Omnipod M system	The Omnipod M system will allow user to use a lower glucose target and improve systems glucose control

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-06-26
• Last updated: 2026-03-03

Locations

2 sites across 1 country: New Zealand

Regulatory

• FDA-regulated device study