Automated insulin delivery with remote real-time continuous glucose monitoring for hospitalized patients with diabetes: a multicenter, single-arm, feasibility trial
Open accessAbstract
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.
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Data on inpatient use of hybrid closed-loop systems (currently commercially available automated insulin delivery [AID] devices) are limited to feasibility trials.
“Data on inpatient use of hybrid closed-loop systems (currently commercially available automated insulin delivery [AID] devices) are limited to feasibility trials (58).”
From 16. Diabetes Care in the Hospital: Standards of Care in Diabetes—2026 (2026) · cites this paper as [58]
The Introduction and Statistical Analysis sections identify this inpatient Omnipod 5 study as a single-arm feasibility trial. They do not establish that data on all commercially available hybrid closed-loop systems are limited to feasibility trials; the Introduction also describes comparative inpatient studies of a different closed-loop system. Page numbers are unavailable in our copy. (LLM, conf=0.82)
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- Authors
- Davis, G. M., Hughes, M. S., Brown, S. A., Sibayan, J., Perez-Guzman, M. C., Stumpf, M., Thompson, Z., Basina, M., Patel, R. M., Hester, J., Abraham, A., Ly, T. T., Chaney, C., Tan, M., Hsu, L., Kollman, C., Beck, R. W., Lal, R., Buckingham, B., & Pasquel, F. J.
- Affiliations
- Emory University (US)
- Stanford Medicine (US)
- University of Virginia (US)
- Jaeb Center for Health Research (US)
- Division of Endocrinology, Metabolism, and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
- Insulet (United States) (US)
- Corresponding author
- Pasquel, Francisco J.
- ORCID
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2023-10
- Volume
- 25
- Issue
- 10
- Pages
- 677-688
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- PMC
- PMC10611957
- OpenAlex
- W4385798381
- Cited by
- 41
- References
- 27
- Citations by year
- 2026: 14 · 2025: 13 · 2024: 13 · 2023: 1
- FWCI
- 8.41
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Technology & Therapeutics (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Insulet Corporation
- National Institutes of Health
- National Institute of General Medical Sciences (K23GM128221)
- National Institute of Diabetes and Digestive and Kidney Diseases (K12DK122550, K23DK122199, K23DK122017, P30DK116074, T32DK007217, P30DK111024)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- artificial pancreas, continuous glucose monitoring, Omnipod 5, time in range, hypoglycemia, diabetic ketoacidosis, medical-surgical units, feasibility, patient satisfaction, CGM accuracy
- MeSH terms
- Blood Glucose, Diabetes Mellitus, Type 1, Feasibility Studies, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Pilot Projects, Blood Glucose Self-Monitoring, Diabetic Ketoacidosis, Insulin, Regular, Human
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