Joanneum Research Forschungsgesellschaft mbH, HEALTH-Institute for Biomedicine and Health Sciences, Graz, Austria.
Unomedical a/s, A ConvaTec Company, Lejre, Denmark.
Diabetes Technol Ther. 2019 Dec;21(12):740-744. doi: 10.1089/dia.2019.0195. Epub 2019 Oct 3.
Continuous subcutaneous insulin infusion (CSII) is a widely used treatment for diabetes patients. Insulin infusion sets (CSII-catheters) are continuously optimized regarding size, handling and safety, but recurring dysfunction (kinking or occlusion), due to different user situations, behavior or chain of events, demand new ways to improve the functionality and safety in patients experiencing these issues. A novel CSII-catheter design (Lantern) features additional lateral perforations, which guarantee functionality even in case of kinking or occlusion. This study aimed to compare functionality, insulin distribution, and failure rate of Lantern and standard catheters using excised human adipose tissue samples. Novel Lantern CSII-catheters (open and artificially occluded) and commercially available standard CSII-catheters were inserted into adipose tissue samples. A mixture of insulin and contrast agent was infused as single bolus (7 IU) with an insulin infusion pump at highest flow rate (1 IU/s). Microtomography images and surface-to-volume ratios were used to assess insulin distribution and depot volume indicating the functionality of CSII-catheters. Failure rate was measured by flow-stop alerts of the pump. We found no difference in the volume of insulin depots compared with the nominal volume of 70 μL. Surface-to-volume ratios showed no significant difference among CSII-catheters. None of the catheters triggered any flow-stop alarm. The novel Lantern CSII-catheter design achieved similar insulin distribution as commercially available CSII-catheters. Moreover, functionality of Lantern CSII-catheters was guaranteed during occlusion, which is an improvement compared with standard CSII-catheters. We conclude that the novel CSII-catheter design has the potential to provide a valuable contribution to patient well-being and safety.
持续皮下胰岛素输注 (CSII) 是一种广泛应用于糖尿病患者的治疗方法。胰岛素输注套件 (CSII-导管) 在尺寸、操作和安全性方面不断得到优化，但由于不同的用户情况、行为或事件链，反复出现的功能障碍（扭结或阻塞）需要新的方法来提高出现这些问题的患者的功能和安全性。一种新型的 CSII-导管设计（灯笼）具有额外的侧向穿孔，即使在扭结或阻塞的情况下也能保证功能。本研究旨在使用离体人脂肪组织样本比较灯笼和标准导管的功能、胰岛素分布和故障发生率。将新型灯笼 CSII-导管（开放和人为阻塞）和市售标准 CSII-导管插入脂肪组织样本中。胰岛素和对比剂的混合物以最高流速（1 IU/s）通过胰岛素输注泵输注作为单次推注（7 IU）。微断层扫描图像和表面积与体积比用于评估胰岛素分布和储存体积，以指示 CSII-导管的功能。通过泵的流量停止警报测量故障发生率。我们发现与 70 μL 的标称体积相比，胰岛素储存量没有差异。CSII-导管之间的表面积与体积比没有显著差异。没有一个导管触发任何流量停止警报。新型灯笼 CSII-导管设计的胰岛素分布与市售 CSII-导管相似。此外，灯笼 CSII-导管在阻塞期间的功能得到保证，与标准 CSII-导管相比有所改进。我们得出结论，新型 CSII-导管设计有可能为患者的福祉和安全做出有价值的贡献。
