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

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 HbA1c ≥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 HbA1c and time in target range (TIR) (70-180 mg/dL).

Results: Participants (N = 24) had a mean (± SD) age of 61 ± 8 years, baseline HbA1c 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). HbA1c (± 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.

Graphical abstract

Figure 1

Individual level and group level glycemic response to AID by baseline insulin regimen. A and B: Individual efficacy outcomes showing HbA_1c (left), percentage TIR 70–180 mg/dL (middle), and percentage time below range (TBR) (<70 mg/dL) (right) for prior basal-bolus injection users (n = 12) (A) and prior basal-only injection users (n = 12) (B). Each set of circles connected by a line indicates the results of a single person with their prior therapy and with 8 weeks of the Omnipod 5 AID System. C and D: Median sensor glucose measurements across participants in group A (n = 12) (C) and group B (n = 12) (D) by time of day during the AID phase (blue line) and the standard therapy phase (red line), with blue and red shaded areas indicating the IQR for each phase. The target range (70–180 mg/dL) is indicated by black dashed lines. Measurements represent a 24-h period from midnight to midnight.