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

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 feature(1) 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. To date, 3 participants have enrolled and are currently using the system: age (mean±SD) 54±12y, weight 79.7±9.0kg, baseline A1C 9.3±0.2% (range 9.1–9.5%), and duration of diabetes 18.3±12.4y. Previous anti-hyperglycemic agents including metformin and GLP-1R agonists were continued. Participants have used Omnipod 5 in Automated Mode ranging from 26 to 53 days. In the preliminary analysis of Automated Mode use, mean glucose of 194±33 mg/dL was achieved, corresponding to a glucose management indicator (GMI) of 8.0±0.8%. Time in range, 70-180mg/dL, was 49.0±19.2%, time <70mg/dL was 0.2±0.2%, >180mg/dL was 50.8±19.4%, and ≥250mg/dL was 19.3±15.6%. Average total daily insulin use was 77.9±41.4 units/day. In the most recent 14 days of use, GMI was further decreased to 7.6±0.5%, and time in range further increased to 57.6±14.1%. There have been no serious adverse events, including severe hypoglycemia, reported in over 110 person-days of system use to date. At completion, this study will provide a novel evaluation of the safety and effectiveness of AID in adults with type 2 diabetes with suboptimal glycemic management, despite the concomitant use of adjuvant anti-hyperglycemic agents. Reference: 1. Forlenza et. al. First outpatient evaluation of a tubeless automated insulin delivery system with customizable glucose targets in children and adults with type 1 diabetes. Diabetes Technol Ther 2021.