Safety and efficacy of the Omnipod 5 automated insulin delivery system in adults with type 2 diabetes: from injections to hybrid closed-loop therapy
Open accessAbstract
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.
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Other studies showed reduction of total daily insulin in AID group previously using MDI.
“Of note, an increase in total daily insulin dose was noted in the subjects while on the AID system (249), whereas other studies have shown either nonsignificant trends for a lower total daily dose of insulin in the AID group (250) or a reduction of total daily insulin in the AID group previously using MDI (251).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [251]
Real-world studies have shown benefits of insulin pumps/AID in adults with type 2 diabetes.
“Real-world studies have also shown benefits of these technologies in adults with type 2 diabetes (235,251).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [251]
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- Authors
- Davis, G. M., Peters, A. L., Bode, B. W., Carlson, A. L., Dumais, B., Vienneau, T. E., Huyett, L. M., & Ly, T. T.
- Affiliations
- Emory University (US)
- University of Southern California (US)
- Atlanta Diabetes Associates (US)
- Park Nicollet Clinic (US)
- Insulet (United States) (US)
- Corresponding author
- Ly, Trang T.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2023-02-14
- Volume
- 46
- Issue
- 4
- Pages
- 742-750
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC10090930
- OpenAlex
- W4320716084
- Cited by
- 69
- References
- 30
- Citations by year
- 2026: 11 · 2025: 28 · 2024: 22 · 2023: 8
- FWCI
- 14.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Insulet Corporation
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- artificial pancreas, Omnipod 5, type 2 diabetes, hybrid closed-loop therapy, continuous glucose monitoring, multiple daily insulin injections, HbA1c, time in range, hypoglycemia, hyperglycemia, insulin pump, feasibility trial, antidiabetic drugs
- MeSH terms
- Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Middle Aged, Blood Glucose Self-Monitoring, Insulin, Regular, Human
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