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

OBJECTIVE 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. RESEARCH DESIGN AND METHODS Participants previously were using either basal-only or basal-bolus insulin injections, with or without the use of a continuous glucose monitor (CGM), and had a baseline HbA(1c) >= 8% (>= 64 mmol/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. Participants who previously used basal-only injections used the AID system in manual mode for 2 weeks before starting AID. Antihyperglycemic agents were continued at clinician discretion. Primary safety outcomes were percentage of time with sensor glucose >= 250 mg/dL and <54 mg/dL during AID. Additional outcomes included HbA(1c) and time in target range (TIR) (70-180 mg/dL). RESULTS Participants (N = 24) had a mean ( SD) age of 61 +/- 8 years, baseline HbA(1c) of 9.4% +/- 0.9% (79 +/- 10 mmol/mol), and diabetes duration of 19 +/- 9 years. Percentage of time with sensor glucose >= 250 mg/dL decreased with AID by 16.9% +/- 16.2% (P < 0.0001), whereas percentage of time at <54 mg/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). HbA(1c) (+/- SD) decreased by 1.3% +/- 0.7% (14 +/- 8 mmol/mol; P < 0.0001) and TIR increased by 21.9% +/- 15.2% (P < 0.0001) without a significant change in total daily insulin or BMI with AID. CONCLUSIONS Findings from this feasibility trial of AID in adults with type 2 diabetes with suboptimal glycemic outcomes justify further evaluation of this technology in this population.