Nonmetabolic Complications of Continuous Subcutaneous Insulin Infusion: A Patient Survey

Abstract

Background: Little is known about the frequencies and types of nonmetabolic complications occurring in type 1 diabetes patients being treated by modern insulin pump therapy (continuous subcutaneous insulin infusion [CSII]), when recorded by standardized questionnaire rather than clinical experience. Subjects and Methods: A self-report questionnaire was completed by successive subjects with type 1 diabetes attending an insulin pump clinic, and those with a duration of CSII of ‡ 6 months were selected for analysis (n = 92). Questions included pump manufacturer, insulin, infusion set type and duration of use, frequency of infusion set and site problems, pump malfunctions, and patient-related problems such as weight change since starting CSII. Results: Median (range) duration of CSII was 3.3 (0.5-32.0) years, and mean -SD duration of infusion set use was 3.2 -0.7 (range 2-6) days. The commonest infusion set problems were kinking (64.1% of subjects) and blockage (54.3%). Blockage was associated with > 3 days of use of infusion sets plus lispro insulin in the pump (relative risk [95% confidence interval], 1.71 [1.03-2.85]; P = 0.07). The commonest infusion site problem was lipohypertrophy (26.1%), which occurred more often in those with long duration of CSII (4.8 [2.38-9.45] vs. 3.0 [1.50-4.25] years; P = 0.01). Pump malfunction had occurred in 48% of subjects (43% in the first year of CSII), with ''no delivery,'' keypad, and battery problems commonly occurring. Although some patients reported weight gain (34%) and some weight loss (15%) on CSII, most patients (51%) reported no change in weight. Conclusions: Pump, infusion set, and infusion site problems remain common with CSII, even with contemporary technology.

Clinical review: insulin pump-associated adverse events in adults and children

“…Overall, the frequency of insulin pump adverse events has not substantially improved over the past 30 years, despite advances in technology, an observation supported by other authors [3,4]. What does appear to have changed is the severity, with reported rates in adults from the 1980s similar to those above, but of a more serious nature.…”

“…Even higher rates have been reported more recently. Pickup et al [3] in 2014 found that 48 % of adult participants experienced pump malfunction at some point; with pump stop or no insulin delivery being the most common event recorded (in 28 % of malfunction events), while Wheeler et al [5] found that 56 % of patient-reported adverse events in children over a 12-month period (or 58 out of a total of 104 events) were due to pump malfunction, either transient or permanent. This study also suggested an association between pump malfunction and adolescence [5], but no association with age has been seen in adults [4].…”

“…This is in order to reduce adverse events including skin irritation, infection, swelling, pain, itching, bruising, and irregularities in insulin delivery (due to occlusion of the catheter, cannula dislodgement, insulin leakage, air pockets in the tubing, or tube kinkage), which can lead to potential loss of glycaemic control [13]. While limited, the recent literature supports this recommendation, with catheter problems appearing to increase from around day 3 of catheter use [3,13].…”

“…This is especially so for those events that are non-metabolic in nature, including cutaneous issues, as well as set/site and pump technical malfunctions. The data that are available suggest that adverse events are surprisingly common [3][4][5][6][7], even in modern-generation pumps. As insulin pump use is likely to increase further, and the technology becomes more elaborate, it appears timely to gain a greater understanding of this important area.…”

De la bomba de insulina y el monitoreo continuo de glucosa al páncreas artificial

“…La complicación asociada al sitio de infusión más frecuente es la lipohipertrofia, afectando al 26% de los usuarios de ICSI 37 . La irritación y/o alergia a los adhesivos del set y la hiperpigmentación en el sitio de infusión también son frecuentes y dependen de la sensibilidad cutánea de cada paciente.…”