Safety and Efficacy of the Omnipod® 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy

Abstract

<p> </p> <p><strong>Objective: </strong>Automated insulin delivery (AID) has rarely been studied in adults with type 2 diabetes. We tested the feasibility of using AID for type 2 diabetes with the Omnipod 5 System in a multicenter outpatient trial. </p> <p><strong>Research Design and Methods: </strong>Participants were previously on either basal-only or basal-bolus insulin injections, with or without the use of continuous glucose monitoring (CGM), and had a baseline HbA1c ≥8% (≥64mmol/mol). Participants completed 2 weeks of CGM sensor data collection (blinded for those not previously using CGM) with their standard therapy (ST), then transitioned to 8 weeks of AID. Prior basal-only participants used the AID system in Manual Mode for 2 weeks prior to starting AID. Anti-hyperglycemic agents were continued at clinician discretion. Primary safety outcomes were percent time with sensor glucose ≥250mg/dL and <54mg/dL during AID. Additional outcomes included HbA1c and time in target range [70-180mg/dL (TIR)]. </p> <p><strong>Results:</strong> Participants (N=24) had a mean (±SD) age of 61±8 years with baseline HbA1c 9.4±0.9% (79±10mmol/mol), and diabetes duration of 19±9 years. Percent time ≥250mg/dL decreased with AID by 16.9±16.2% (p<0.0001) while percent time <54mg/dL remained low during both ST and AID (median [interquartile range] 0.0% [0.00%, 0.06%] vs. 0.00% [0.00%, 0.03%], p=0.4543). HbA1c decreased by 1.3±0.7% (14±8mmol/mol, p<0.0001) and TIR increased by 21.9±15.2% (p<0.0001) without a significant change in total daily insulin or body mass index with AID.</p> <p><strong>Conclusions:</strong> Findings from this feasibility trial of AID in adults with type 2 diabetes with sub-optimal glycemic outcomes justify further evaluation of this technology in this population. </p>