NCT07070830

Simplified Onboarding in Adults With Type 2 Diabetes

Feasibility of Simplified Onboarding in Adults With Type 2 Diabetes Using Automated Insulin Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System. There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode. An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Active Comparator: Omnipod M System with lower starting dose	Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
DEVICE	Active Comparator: Omnipod M System with higher starting dose	Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-01-06
• Completion: 2026-01-06
• First posted: 2025-07-17
• Last updated: 2026-01-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study