Simplified Onboarding in Adults With Type 2 Diabetes

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.

NCT Number	NCT07070830
Lead Sponsor	Insulet Corporation
Conditions	Type 2 Diabetes Mellitus
Enrollment	56 participants
Start Date	2025-07-18
Primary Completion	2026-01-06 (estimated)
Study Completion	2026-01-06 (estimated)
Updated on ClinicalTrials.gov	2026-01-30