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Technology/Device
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
Jiyun Park, Nammi Park, Sangjin Han, You-Bin Lee, Gyuri Kim, Sang-Man Jin, Woo Je Lee, Jae Hyeon Kim
Diabetes Metab J. 2022;46(6):941-947.   Published online March 8, 2022
DOI: https://doi.org/10.4093/dmj.2021.0299
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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.

Citations

Citations to this article as recorded by  
  • Multilayer track‐etched membrane‐based electroosmotic pump for drug delivery
    Qian Yang, Zebo Zhang, Junshu Lin, Boyu Zhu, Rongying Yu, Xinru Li, Bin Su, Bo Zhao
    ELECTROPHORESIS.2024; 45(5-6): 433.     CrossRef
  • A true continuous healthcare system for type 1 diabetes
    Jiyong Kim, Salman Khan, Eun Kyu Kim, Hye-Jun Kil, Bo Min Kang, Hyo Geon Lee, Jin-Woo Park, Jun Young Yoon, Woochul Kim
    Nano Energy.2023; 113: 108553.     CrossRef

Diabetes Metab J : Diabetes & Metabolism Journal