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Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy
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-onl...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Diabetes Association
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10090930/ https://www.ncbi.nlm.nih.gov/pubmed/36787903 http://dx.doi.org/10.2337/dc22-1915 |
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author | Davis, Georgia M. Peters, Anne L. Bode, Bruce W. Carlson, Anders L. Dumais, Bonnie Vienneau, Todd E. Huyett, Lauren M. Ly, Trang T. |
author_facet | Davis, Georgia M. Peters, Anne L. Bode, Bruce W. Carlson, Anders L. Dumais, Bonnie Vienneau, Todd E. Huyett, Lauren M. Ly, Trang T. |
author_sort | Davis, Georgia M. |
collection | PubMed |
description | 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 HbA(1c) ≥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 HbA(1c) and time in target range (TIR) (70–180 mg/dL). RESULTS: Participants (N = 24) had a mean (± SD) age of 61 ± 8 years, baseline HbA(1c) 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). HbA(1c) (± 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. |
format | Online Article Text |
id | pubmed-10090930 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | American Diabetes Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-100909302023-04-13 Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy Davis, Georgia M. Peters, Anne L. Bode, Bruce W. Carlson, Anders L. Dumais, Bonnie Vienneau, Todd E. Huyett, Lauren M. Ly, Trang T. Diabetes Care Original Article 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 HbA(1c) ≥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 HbA(1c) and time in target range (TIR) (70–180 mg/dL). RESULTS: Participants (N = 24) had a mean (± SD) age of 61 ± 8 years, baseline HbA(1c) 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). HbA(1c) (± 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. American Diabetes Association 2023-04 2023-02-14 /pmc/articles/PMC10090930/ /pubmed/36787903 http://dx.doi.org/10.2337/dc22-1915 Text en © 2023 by the American Diabetes Association https://www.diabetesjournals.org/journals/pages/licenseReaders may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at https://www.diabetesjournals.org/journals/pages/license. |
spellingShingle | Original Article Davis, Georgia M. Peters, Anne L. Bode, Bruce W. Carlson, Anders L. Dumais, Bonnie Vienneau, Todd E. Huyett, Lauren M. Ly, Trang T. Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy |
title | Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy |
title_full | Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy |
title_fullStr | Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy |
title_full_unstemmed | Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy |
title_short | Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy |
title_sort | safety and efficacy of the omnipod 5 automated insulin delivery system in adults with type 2 diabetes: from injections to hybrid closed-loop therapy |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10090930/ https://www.ncbi.nlm.nih.gov/pubmed/36787903 http://dx.doi.org/10.2337/dc22-1915 |
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