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Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial
In adults with type 2 diabetes, the benefits of fully closed-loop insulin delivery, which does not require meal bolusing, are unclear. In an open-label, single-center, randomized crossover study, 26 adults with type 2 diabetes (7 women and 19 men; (mean ± s.d.) age, 59 ± 11 years; baseline glycated...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Nature Publishing Group US
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9873557/ https://www.ncbi.nlm.nih.gov/pubmed/36631592 http://dx.doi.org/10.1038/s41591-022-02144-z |
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author | Daly, Aideen B. Boughton, Charlotte K. Nwokolo, Munachiso Hartnell, Sara Wilinska, Malgorzata E. Cezar, Alina Evans, Mark L. Hovorka, Roman |
author_facet | Daly, Aideen B. Boughton, Charlotte K. Nwokolo, Munachiso Hartnell, Sara Wilinska, Malgorzata E. Cezar, Alina Evans, Mark L. Hovorka, Roman |
author_sort | Daly, Aideen B. |
collection | PubMed |
description | In adults with type 2 diabetes, the benefits of fully closed-loop insulin delivery, which does not require meal bolusing, are unclear. In an open-label, single-center, randomized crossover study, 26 adults with type 2 diabetes (7 women and 19 men; (mean ± s.d.) age, 59 ± 11 years; baseline glycated hemoglobin (HbA1c), 75 ± 15 mmol mol(−1) (9.0% ± 1.4%)) underwent two 8-week periods to compare the CamAPS HX fully closed-loop app with standard insulin therapy and a masked glucose sensor (control) in random order, with a 2-week to 4-week washout between periods. The primary endpoint was proportion of time in target glucose range (3.9–10.0 mmol l(−1)). Analysis was by intention to treat. Thirty participants were recruited between 16 December 2020 and 24 November 2021, of whom 28 were randomized to two groups (14 to closed-loop therapy first and 14 to control therapy first). Proportion of time in target glucose range (mean ± s.d.) was 66.3% ± 14.9% with closed-loop therapy versus 32.3% ± 24.7% with control therapy (mean difference, 35.3 percentage points; 95% confidence interval (CI), 28.0–42.6 percentage points; P < 0.001). Time > 10.0 mmol l(−1) was 33.2% ± 14.8% with closed-loop therapy versus 67.0% ± 25.2% with control therapy (mean difference, −35.2 percentage points; 95% CI, −42.8 to −27.5 percentage points; P < 0.001). Mean glucose was lower during the closed-loop therapy period than during the control therapy period (9.2 ± 1.2 mmol l(−1) versus 12.6 ± 3.0 mmol l(−1), respectively; mean difference, −3.6 mmol l(−1); 95% CI, −4.6 to −2.5 mmol l(−1); P < 0.001). HbA1c was lower following closed-loop therapy (57 ± 9 mmol mol(−1) (7.3% ± 0.8%)) than following control therapy (72 ± 13 mmol mol(−1) (8.7% ± 1.2%); mean difference, −15 mmol mol(−1); 95% CI, −11 to −20 mmol l(−1) (mean difference, −1.4%; 95% CI, −1.0 to −1.8%); P < 0.001). Time < 3.9 mmol l(−1) was similar between treatments (a median of 0.44% (interquartile range, 0.19–0.81%) during the closed-loop therapy period versus a median of 0.08% (interquartile range, 0.00–1.05%) during the control therapy period; P = 0.43). No severe hypoglycemia events occurred in either period. One treatment-related serious adverse event occurred during the closed-loop therapy period. Fully closed-loop insulin delivery improved glucose control without increasing hypoglycemia compared with standard insulin therapy and may represent a safe and efficacious method to improve outcomes in adults with type 2 diabetes. This study is registered with ClinicalTrials.gov (NCT04701424). |
format | Online Article Text |
id | pubmed-9873557 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Nature Publishing Group US |
record_format | MEDLINE/PubMed |
spelling | pubmed-98735572023-01-26 Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial Daly, Aideen B. Boughton, Charlotte K. Nwokolo, Munachiso Hartnell, Sara Wilinska, Malgorzata E. Cezar, Alina Evans, Mark L. Hovorka, Roman Nat Med Article In adults with type 2 diabetes, the benefits of fully closed-loop insulin delivery, which does not require meal bolusing, are unclear. In an open-label, single-center, randomized crossover study, 26 adults with type 2 diabetes (7 women and 19 men; (mean ± s.d.) age, 59 ± 11 years; baseline glycated hemoglobin (HbA1c), 75 ± 15 mmol mol(−1) (9.0% ± 1.4%)) underwent two 8-week periods to compare the CamAPS HX fully closed-loop app with standard insulin therapy and a masked glucose sensor (control) in random order, with a 2-week to 4-week washout between periods. The primary endpoint was proportion of time in target glucose range (3.9–10.0 mmol l(−1)). Analysis was by intention to treat. Thirty participants were recruited between 16 December 2020 and 24 November 2021, of whom 28 were randomized to two groups (14 to closed-loop therapy first and 14 to control therapy first). Proportion of time in target glucose range (mean ± s.d.) was 66.3% ± 14.9% with closed-loop therapy versus 32.3% ± 24.7% with control therapy (mean difference, 35.3 percentage points; 95% confidence interval (CI), 28.0–42.6 percentage points; P < 0.001). Time > 10.0 mmol l(−1) was 33.2% ± 14.8% with closed-loop therapy versus 67.0% ± 25.2% with control therapy (mean difference, −35.2 percentage points; 95% CI, −42.8 to −27.5 percentage points; P < 0.001). Mean glucose was lower during the closed-loop therapy period than during the control therapy period (9.2 ± 1.2 mmol l(−1) versus 12.6 ± 3.0 mmol l(−1), respectively; mean difference, −3.6 mmol l(−1); 95% CI, −4.6 to −2.5 mmol l(−1); P < 0.001). HbA1c was lower following closed-loop therapy (57 ± 9 mmol mol(−1) (7.3% ± 0.8%)) than following control therapy (72 ± 13 mmol mol(−1) (8.7% ± 1.2%); mean difference, −15 mmol mol(−1); 95% CI, −11 to −20 mmol l(−1) (mean difference, −1.4%; 95% CI, −1.0 to −1.8%); P < 0.001). Time < 3.9 mmol l(−1) was similar between treatments (a median of 0.44% (interquartile range, 0.19–0.81%) during the closed-loop therapy period versus a median of 0.08% (interquartile range, 0.00–1.05%) during the control therapy period; P = 0.43). No severe hypoglycemia events occurred in either period. One treatment-related serious adverse event occurred during the closed-loop therapy period. Fully closed-loop insulin delivery improved glucose control without increasing hypoglycemia compared with standard insulin therapy and may represent a safe and efficacious method to improve outcomes in adults with type 2 diabetes. This study is registered with ClinicalTrials.gov (NCT04701424). Nature Publishing Group US 2023-01-11 2023 /pmc/articles/PMC9873557/ /pubmed/36631592 http://dx.doi.org/10.1038/s41591-022-02144-z Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Daly, Aideen B. Boughton, Charlotte K. Nwokolo, Munachiso Hartnell, Sara Wilinska, Malgorzata E. Cezar, Alina Evans, Mark L. Hovorka, Roman Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
title | Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
title_full | Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
title_fullStr | Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
title_full_unstemmed | Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
title_short | Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
title_sort | fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9873557/ https://www.ncbi.nlm.nih.gov/pubmed/36631592 http://dx.doi.org/10.1038/s41591-022-02144-z |
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