EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults with Type 2 Diabetes

Age at time of consent 18-75 years (inclusive)

Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening

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

For basal only users, screening A1C ≥7.5% and <14.0%. For basal bolus users (i.e., all others), screening A1C ≥6.0% and <14.0%.

• A1C measurement within 28 days prior to enrollment is acceptable

Willing to use only the following types of U-100 insulin while using the study pump: Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic/biosimilar equivalents

Willing to use only study-provided Libre 2 Plus or 3 Plus sensor during the study and not use another sensor

Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities

No anticipated need to newly initiate noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose lowering effect during the 26-week RCT phase. (Additions or changes in these medications will be permitted during the Extension Phase)

If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose-lowering effect, prescribed dose has been stable for 6 weeks prior to baseline CGM collection; and there is not an anticipated need to increase the dose during the 26-week trial phase (dose reductions will be permitted for safety).

Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol

Willing to wear the system, including Pods, continuously throughout the 26-week trial phase

Willing and able to sign the Informed Consent Form (ICF)

Able to read and understand English

If of childbearing potential, willing and able to have pregnancy testing