Wheeler Benjamin J, Donaghue Kim C, Heels Kristine, Ambler Geoffrey R
1 The Institute of Endocrinology and Diabetes , The Children's Hospital at Westmead, Sydney, Australia .
Diabetes Technol Ther. 2014 Apr;16(4):204-7. doi: 10.1089/dia.2013.0315. Epub 2013 Dec 6.
Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in dealing with them.
We approached all families of children and adolescents ≤ 19 years of age on CSII attending the diabetes clinic over a 16-week clinic cycle. Participants completed a retrospective questionnaire examining issues over the previous 12 months. Data on pump adverse events as well as answers to questions pertaining to education and confidence were collected.
Our survey received a response rate of 99%, with 235 of the 238 families approached participating. In the preceding 12 months, 104 of 230 (45%) had reported at least one pump-related adverse event (either mechanical or set-related), with an associated 52 of 229 (23%) resulting in pump replacement. This equated to a minimum incidence density of 53 adverse events/100 person-years. Additionally, 18 of 230 (8%) reported a hospital admission or emergency department attendance as a consequence. Pump malfunction and infusion set/site failures were the most common events reported, with one or more events in 58 of 104 (56%) and 47 of 104 (45%), respectively. Adverse events, excluding set/site failures, were associated with older age (13.1 ± 3.4 years vs. 11.9 ± 4 years; P = 0.02).
This is the first study to look at family perceptions of adverse events while using modern CSII. It highlights a high self-reported rate of CSII-related adverse events, pump replacement, and subsequent presentation to the hospital. Potential areas for additional targeted education are identified. Further prospective study examining pump adverse event characteristics and incidence is warranted.
胰岛素泵（用于持续皮下胰岛素输注[CSII]）在1型糖尿病中广泛应用。尽管对其治疗效果已有大量研究，但关于CSII相关不良事件的近期数据较少，且尚无关于家庭对不良事件的认知及其应对信心的数据。
在为期16周的门诊周期内，我们对所有年龄≤19岁且正在使用CSII的糖尿病门诊患儿及青少年的家庭进行了调查。参与者完成了一份回顾性问卷，调查过去12个月内的相关问题。收集了胰岛素泵不良事件的数据以及与教育和信心相关问题的答案。
我们的调查回复率为99%，238个受访家庭中有235个参与。在之前的12个月里，230个家庭中有104个（45%）报告了至少一次与胰岛素泵相关的不良事件（机械性或与装置相关），其中229个家庭中有52个（23%）因此更换了胰岛素泵。这相当于不良事件的最低发病密度为53例/100人年。此外，230个家庭中有18个（8%）报告因此住院或前往急诊科就诊。胰岛素泵故障和输液装置/部位故障是报告最多的事件，分别有104个家庭中的58个（56%）和47个（45%）发生了一个或多个此类事件。排除装置/部位故障后的不良事件与年龄较大有关（13.1±3.4岁 vs. 11.9±4岁；P = 0.02）。
这是第一项研究使用现代CSII时家庭对不良事件的认知的研究。它突出了自我报告的CSII相关不良事件、胰岛素泵更换及随后就医的高发生率。确定了需要进一步针对性教育的潜在领域。有必要进行进一步的前瞻性研究，以检查胰岛素泵不良事件的特征和发生率。
