Wheeler Benjamin J, Heels Kristine, Donaghue Kim C, Reith David M, Ambler Geoffrey R
1 The Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead , Sydney, Australia .
Diabetes Technol Ther. 2014 Sep;16(9):558-62. doi: 10.1089/dia.2013.0388. Epub 2014 May 5.
Intensive insulin regimens are now the mainstay of modern, type 1 diabetes mellitus management. Insulin pumps (CSII) are a key technique used. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events (AEs) and their incidence and characteristics.
Phone calls to our 24-h diabetes support service were screened for CSII-associated AEs. Phone interviews were conducted with the parent/patient, within 96 h of the event. Interviews explored AE characteristics and the role of the user, as well as questions relating to outcome and the impact to the family and patient. Comparisons were made with clinic CSII patients not reporting an AE.
Over a 16-week study period, 50 confirmed AEs occurred in 45 of 405 (11.1%) patients. This was annualized to an AE incidence of 40 AEs/100 person-years. Pump malfunction and infusion set/site failures were the most common events reported, occurring in 27 (54.0%) and 18 (36.0%) AEs, respectively. A user- or education-related issue was implicated in 22 (44.0%) events. Pump replacement occurred in 19 of 50 occurrences (38.0%). Additionally, 16 (32.0%) reported a hospital admission or emergency department attendance as a consequence. When compared with those on CSII not reporting an AE, AEs were associated with age <10 years (odds ratio=3.2 [95% confidence interval, 1.7-6.1]) but not with gender, glycosylated hemoglobin, diabetes duration, or pumping duration.
This is the first prospective study to look at AEs in modern-generation insulin pumps. AEs appear common and should be anticipated. Their origin is multifactorial, with the pump, associated consumables, and the user all being important factors. Ongoing support and anticipatory education are essential to minimize pump-associated AEs and their impact.
强化胰岛素治疗方案现已成为现代1型糖尿病管理的主要手段。胰岛素泵（持续皮下胰岛素输注，CSII）是一项关键技术。尽管对治疗结果已有大量研究，但关于CSII相关不良事件（AE）及其发生率和特征的近期数据却很少。
对拨打我们24小时糖尿病支持服务热线的电话进行筛查，以确定是否存在CSII相关不良事件。在事件发生后96小时内，对家长/患者进行电话访谈。访谈探讨了不良事件的特征、使用者的作用，以及与结果、对家庭和患者的影响相关的问题。并与未报告不良事件的门诊CSII患者进行比较。
在为期16周的研究期间，405例患者中的45例（11.1%）发生了50例确诊的不良事件。年化不良事件发生率为40例/100人年。泵故障和输注装置/部位故障是报告的最常见事件，分别发生在27例（54.0%）和18例（36.0%）不良事件中。22例（44.0%）事件涉及使用者或教育相关问题。50次事件中有19次（38.0%）进行了泵更换。此外，16例（32.0%）报告因此住院或到急诊科就诊。与未报告不良事件的CSII使用者相比，不良事件与年龄<10岁相关（优势比=3.2 [95%置信区间，1.7 - 6.1]），但与性别、糖化血红蛋白、糖尿病病程或使用泵的时间无关。
这是第一项观察现代胰岛素泵不良事件的前瞻性研究。不良事件似乎很常见，应予以预期。其起源是多因素的，泵、相关耗材和使用者都是重要因素。持续的支持和预防性教育对于将泵相关不良事件及其影响降至最低至关重要。
