Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks

Inclusion Criteria: 1. Age at time of consent 18-75 years (inclusive) 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening 3. On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months excluded) to initiating baseline CGM data collection. * Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin; or (2) basal insulin only (without bolus insulin). * Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime insulin dose per day, or a non-automated insulin pump * Inhaled insulin may be used in addition to or instead of mealtime injections pre-study and as part of the Control group 4. For basal only users, screening A1C ≥7.5% and \