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