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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| Format: | Article |
| Language: | English |
| Published: |
Korean Diabetes Association
2022-11-01
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| Series: | Diabetes & Metabolism Journal |
| Subjects: | |
| Online Access: | http://e-dmj.org/upload/pdf/dmj-2021-0299.pdf |
| _version_ | 1797987491455696896 |
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| author | Jiyun Park Nammi Park Sangjin Han You-Bin Lee Gyuri Kim Sang-Man Jin Woo Je Lee Jae Hyeon Kim |
| author_facet | Jiyun Park Nammi Park Sangjin Han You-Bin Lee Gyuri Kim Sang-Man Jin Woo Je Lee Jae Hyeon Kim |
| author_sort | Jiyun Park |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-11T07:49:19Z |
| format | Article |
| id | doaj.art-485ccd4c763c458d9955bc34d9dcc59e |
| institution | Directory Open Access Journal |
| issn | 2233-6079 2233-6087 |
| language | English |
| last_indexed | 2024-04-11T07:49:19Z |
| publishDate | 2022-11-01 |
| publisher | Korean Diabetes Association |
| record_format | Article |
| series | Diabetes & Metabolism Journal |
| spelling | doaj.art-485ccd4c763c458d9955bc34d9dcc59e2022-12-22T04:36:09ZengKorean Diabetes AssociationDiabetes & Metabolism Journal2233-60792233-60872022-11-0146694194710.4093/dmj.2021.02992644A 4-Week, Two-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of EOPatch in Well-Controlled Type 1 Diabetes MellitusJiyun Park0Nammi Park1Sangjin Han2You-Bin Lee3Gyuri Kim4Sang-Man Jin5Woo Je Lee6Jae Hyeon Kim7 Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Divisions of Clinical Affairs, EOFLOW Co. Ltd., Seongnam, Korea Hardware Development, EOFLOW Co. Ltd., Seongnam, Korea Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaThis 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.http://e-dmj.org/upload/pdf/dmj-2021-0299.pdfdiabetes mellitus, type 1glycated hemoglobin ainsulininsulin infusion systems |
| spellingShingle | Jiyun Park Nammi Park Sangjin Han You-Bin Lee Gyuri Kim Sang-Man Jin Woo Je Lee Jae Hyeon Kim 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 Diabetes & Metabolism Journal diabetes mellitus, type 1 glycated hemoglobin a insulin insulin infusion systems |
| 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 | diabetes mellitus, type 1 glycated hemoglobin a insulin insulin infusion systems |
| url | http://e-dmj.org/upload/pdf/dmj-2021-0299.pdf |
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