Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Ypsomed AG, Burgdorf, Switzerland.
Diabetes Technol Ther. 2020 Oct;22(10):734-741. doi: 10.1089/dia.2019.0445. Epub 2020 Apr 6.
There is limited evidence supporting a replacement interval of infusion sets for continuous subcutaneous insulin infusion (CSII). The aim of this study was to investigate if steel and soft cannula infusion sets can be used in CSII therapy for up to 7 days without negative impact on infusion sites or glycemic control. The insulin infusion sets YpsoPump Orbitmicro (steel needle) and YpsoPump Orbitsoft (soft cannula) were each used for up to 7 days by 40 adult subjects with CSII. Each subject used both infusion set types twice. Early replacement reasons were documented and glycemic control was monitored. Of 160 inserted insulin infusion sets, 66% were used for 7 days with no obvious difference between steel and soft infusion sets. The mean wearing time was 6.2 ± 1.5 days. Main reasons for early infusion set replacements were occlusions (19%), plaster issues (4%), and accidental pull-out (4%). Comparing glycemic control during day 1-3 and 1-7, mean glucose was 146 ± 21 mg/dL versus 148 ± 18 mg/dL, coefficient of variation was 34% ± 7% versus 33% ± 5%, and insulin dose was 40 ± 11 U versus 41 ± 11 U. Only mild and nonserious infusion site reactions occurred. In this study, 7 days indwelling time of insulin infusion sets did not show a clinically relevant impact on glycemic control or insulin requirements and the infectious risk appeared to be low. The replacement interval of infusion sets may be individualized beyond the currently labeled maximum use duration.
目前仅有有限的证据支持连续皮下胰岛素输注（CSII）的输注套件更换间隔。本研究旨在探讨钢针和软套管输注套件是否可在 CSII 治疗中使用长达 7 天而不会对输注部位或血糖控制产生负面影响。40 名接受 CSII 治疗的成年患者分别使用 YpsoPump Orbitmicro（钢针）和 YpsoPump Orbitsoft（软套管）胰岛素输注套件长达 7 天。每位患者两种输注套件各使用两次。记录早期更换的原因并监测血糖控制情况。在 160 个插入的胰岛素输注套件中，66%的套件使用了 7 天，钢针和软套管输注套件之间没有明显差异。平均佩戴时间为 6.2±1.5 天。早期更换输注套件的主要原因是堵塞（19%）、石膏问题（4%）和意外拔出（4%）。比较第 1-3 天和第 1-7 天的血糖控制情况，平均血糖分别为 146±21mg/dL 和 148±18mg/dL，变异系数分别为 34%±7%和 33%±5%，胰岛素剂量分别为 40±11U 和 41±11U。仅发生轻度且非严重的输注部位反应。在这项研究中，胰岛素输注套件留置 7 天不会对血糖控制或胰岛素需求产生明显的临床相关影响，感染风险似乎较低。输注套件的更换间隔时间可能会超过目前规定的最长使用时间而个体化。
