Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring for Hospitalized Patients with Diabetes: A Multicenter, Single-Arm, Feasibility Trial

• Type of Material: Article
• Authors: Georgia Davis, Emory University; Michael S. Hughes, Stanford University; Sue A. Brown, University of Virgnia; Judy Sibayan, Jaeb center for Health Research; M. Citlalli Perez-Guzman, Emory University; Meaghan Stumpf, University of Virginia; Zachary Thompson, Jaeb Center for Health Research; Marina Basina, Stanford University; Ronak M. Patel, University of Virginia; Joi Hester, Emory University; Amalia Abraham, Emory University; Trang T. Ly, Insulet Corporation; Cherie Chaney, University of Virginia; Marilyn Tan, Stanford University; Liana Hsu, Stanford University; Craig Kollman, Jaeb Center for Health Research; Roy W. Beck, Jaeb Center for Health Research; Rayhan Lal, Stanford University; Bruce Buckingham, Stanford University; Francisco Javier Pasquel, Emory University
• Language: English
• Date: 2023-10-12
• Publisher: Mary Ann Liebert, Inc.
• Publication Version: Final Published Version
• Copyright Statement: © Georgia M. Davis, et al., 2023; Published by Mary Ann Liebert, Inc.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): https://doi.org/10.1089%2Fdia.2023.0304
• Title of Journal or Parent Work: Diabetes Technology and Therapeutics
• Volume: 25
• Issue: 10
• Start Page: 677
• End Page: 688
• Grant/Funding Information: This investigator-initiated study was supported by Insulet. The work of Georgia M. Davis, Michael S. Hughes, Sue A. Brown, Rayhan Lal, and Francisco J. Pasquel is partly supported from the U.S. National Institutes of Health (K23 DK122199 [Georgia M. Davis]; 5T32 DK007217 and 5K12DK122550 [Michael S. Hughes]; 1K23 DK122017 and P30DK116074 [Rayhan Lal]; 5P30DK111024 and 5K23GM128221 [Francisco J. Pasquel]).
• Keywords: Impatient diabetes; Automated insulin delivery; Hybrid closed loop
• Research Categories: Health Sciences, General

Abstract

Introduction: Multiple daily injection 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 diabetes on nonintensive care unit 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 h 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; 18 used the system for a total of 96 days (mean 5.3 ± 3.1 days per patient), and 16 had sufficient CGM data required for analysis. Median percent time in automated mode was 95% (interquartile range 92%–98%) for the 18 system users, and the 16 participants with >48 h 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. These results warrant further investigation in randomized trials.