EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With 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
• 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