The Use of Omnipod® 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes With Suboptimal Glycemic Management: From Injections to Closed-Loop Therapy

摘要

Advances in automated insulin delivery (AID), integrating continuous glucose monitoring (CGM), insulin pump therapy, and dynamic insulin modulation, have mostly centered on type 1 diabetes. Very little data exists to characterize the use of AID in adults with type 2 diabetes in the outpatient setting despite the significant burden of disease. The increasing adoption of diabetes technology by this heterogenous population suggests that clinical evaluation of AID in type 2 diabetes is necessary. In this study, we seek to enroll adults with type 2 diabetes, previously on either multiple daily injections (MDI) or basal insulin only (pump naïve), both CGM users and CGM naïve, with A1C > 8%, to start AID using the tubeless, on-body Omnipod 5 system with insulin pod and Dexcom G6 sensor. This system has the novel feature1 of customizable glucose targets from 110-150mg/dL, which is useful for gradual reduction of mean glucose levels in patients acclimated to hyperglycemic ranges. In addition, the system adapts to the persistent hyperglycemia commonly seen in type 2 diabetes by increasing insulin delivery with each pod change. This feasibility study will enroll a minimum of 24 participants, following them through a 2-week baseline assessment and then an 8-week period of Omnipod 5 use in Automated Mode, all via the outpatient setting.