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A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus

This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The c...

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Autores principales: Park, Jiyun, Park, Nammi, Han, Sangjin, Lee, You-Bin, Kim, Gyuri, Jin, Sang-Man, Lee, Woo Je, Kim, Jae Hyeon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Diabetes Association 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9723198/
https://www.ncbi.nlm.nih.gov/pubmed/35255546
http://dx.doi.org/10.4093/dmj.2021.0299
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author Park, Jiyun
Park, Nammi
Han, Sangjin
Lee, You-Bin
Kim, Gyuri
Jin, Sang-Man
Lee, Woo Je
Kim, Jae Hyeon
author_facet Park, Jiyun
Park, Nammi
Han, Sangjin
Lee, You-Bin
Kim, Gyuri
Jin, Sang-Man
Lee, Woo Je
Kim, Jae Hyeon
author_sort Park, Jiyun
collection PubMed
description This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The co-primary end points were patch pump usage time for one attachment and number of serious adverse events related to the patch pump. The secondary end points were total amount of insulin injected per patch and changes in glycemic parameters including continuous glucose monitoring data compared to those at study entry. The median usage time per patch was 84.00 hours (interquartile range, 64.50 to 92.50). Serious adverse events did not occur during the trial. Four weeks later, time in range 70 to 180 mg/dL was significantly improved (70.71%±17.14 % vs. 82.96%±9.14%, P=0.01). The times spent below range (<54 mg/dL) and above range (>180 mg/dL) also improved (All P<0.05). Four-week treatment with a tubeless patch pump was safe and led to clinical improvement in glycemic control.
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spelling pubmed-97231982022-12-14 A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus Park, Jiyun Park, Nammi Han, Sangjin Lee, You-Bin Kim, Gyuri Jin, Sang-Man Lee, Woo Je Kim, Jae Hyeon Diabetes Metab J Short Communication This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM). This 4-week, two-center, open-label, single-arm study enrolled 10 adult patients diagnosed with T1DM with glycosylated hemoglobin less than 7.5%. The co-primary end points were patch pump usage time for one attachment and number of serious adverse events related to the patch pump. The secondary end points were total amount of insulin injected per patch and changes in glycemic parameters including continuous glucose monitoring data compared to those at study entry. The median usage time per patch was 84.00 hours (interquartile range, 64.50 to 92.50). Serious adverse events did not occur during the trial. Four weeks later, time in range 70 to 180 mg/dL was significantly improved (70.71%±17.14 % vs. 82.96%±9.14%, P=0.01). The times spent below range (<54 mg/dL) and above range (>180 mg/dL) also improved (All P<0.05). Four-week treatment with a tubeless patch pump was safe and led to clinical improvement in glycemic control. Korean Diabetes Association 2022-11 2022-03-08 /pmc/articles/PMC9723198/ /pubmed/35255546 http://dx.doi.org/10.4093/dmj.2021.0299 Text en Copyright © 2022 Korean Diabetes Association https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Short Communication
Park, Jiyun
Park, Nammi
Han, Sangjin
Lee, You-Bin
Kim, Gyuri
Jin, Sang-Man
Lee, Woo Je
Kim, Jae Hyeon
A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus
title A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus
title_full A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus
title_fullStr A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus
title_full_unstemmed A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus
title_short A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes Mellitus
title_sort 4-week, two-center, open-label, single-arm study to evaluate the safety and efficacy of eopatch in well-controlled type 1 diabetes mellitus
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9723198/
https://www.ncbi.nlm.nih.gov/pubmed/35255546
http://dx.doi.org/10.4093/dmj.2021.0299
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