Abstract

Introduction Multiple daily injection (MDI) insulin therapy frequently fails to meet hospital glycemic goals and is prone to hypoglycemia. Automated insulin delivery (AID) with remote glucose monitoring offers a solution to these shortcomings. Research Design and Methods In a single-arm multicenter pilot trial, we tested the feasibility, safety, and effectiveness of the Omnipod 5 AID System with real-time continuous glucose monitoring (CGM) for up to 10 days in hospitalized patients with insulin-requiring requiring diabetes on non-ICU medical-surgical units. Primary endpoints included the proportion of time in automated mode and percent time in range (TIR, 70-180 mg/dl) among participants with >48 hours of CGM data. Safety endpoints included incidence of severe hypoglycemia and diabetes-related ketoacidosis (DKA). Additional glycemic endpoints, CGM accuracy, and patient satisfaction were also explored. Results Twenty-two participants were enrolled; eighteen used the system for a total of 96 days (mean 5.3±3.1 days per patient), and sixteen had sufficient CGM data required for analysis. Median percent time in automated mode was 95% (IQR 92-98%) for the 18 system users, and the 16 participants with >48 hours of CGM data achieved an overall TIR of 68±16%, with 0.17±0.3% time <70 mg/dl and 0.06±0.2% time <54 mg/dl. Sensor mean glucose was 167±21 mg/dl. There were no DKA or severe hypoglycemic events. All participants reported satisfaction with the system at study end. Conclusions The use of AID with a disposable tubeless patch-pump along with remote real-time CGM is feasible in the hospital setting.

View details for DOI 10.1089/dia.2023.0304

View details for PubMedID 37578778