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

Diabetes Technology & Therapeutics · 20 authors, 6 centres

AI SUMMARY

FIDELITY 100%

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

The system was feasible, with high time in automated mode, and achieved a time-in-range of 68% without severe hypoglycemia or DKA.

Full summary

391 CHARS

There were no episodes of severe hypoglycemia or DKA. All participants reported satisfaction. The study demonstrated the feasibility of using this system in a hospital setting. Limitations include the small sample size, single-arm design, and the fact that two participants were excluded from analysis due to insufficient data. The results warrant further investigation in randomized trials.

STUDY TYPE

RCT

SPECIALTY

endocrinology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10611957

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

Diabetes Technology & Therapeutics

READ THE FULL PAPER

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.

CITATION EXPORT

Georgia M. Davis, Michael S. Hughes, Sue A. Brown et al.. Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring for Hospitalized Patients with Diabetes: A Multicenter, Single-Arm, Feasibility Trial. Diabetes Technology & Therapeutics. (2023). https://doi.org/10.1089/dia.2023.0304

AUTHORS

20 · 6 CENTRES

Georgia M. Davis, Michael S. Hughes, Sue A. Brown, Judy Sibayan, M. Citlalli Perez-Guzman, Meaghan Stumpf, Zachary Thompson, Marina Basina, Ronak M. Patel, Joi Hester, Amalia Abraham, Trang T. Ly, Cherie Chaney, Marilyn Tan, Liana Hsu, Craig Kollman, Roy W. Beck, Rayhan Lal, Bruce Buckingham, Francisco J. Pasquel

1Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
2Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University, Stanford, California, USA.
3Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.
4Jaeb Center for Health Research, Tampa, Florida, USA.
5Insulet Corporation, Acton, Massachusetts, USA.
6Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University, Stanford, California, USA.