Royal Bournemouth Hospital, Bournemouth, United Kingdom.
Diabetes Technol Ther. 2012 Nov;14(11):1018-22. doi: 10.1089/dia.2012.0080.
The aim of this study was to determine whether changes in local skin temperature over which the infusion catheters pass when using insulin pump therapy and the choice of rapid-acting insulin analog influence the risk of catheter occlusion.
Twenty healthy volunteers were assigned to wear insulin pumps primed with insulin glulisine and insulin aspart in a randomized order each for a duration of 5 days and a temperature probe (taped to the skin near the insulin catheter). To reproduce the effect of subcutaneous infusion, the insulin catheter was inserted into an absorbent sponge in a plastic bag strapped to the subject's abdomen. Basal infusion rates were programmed at 0.2 IU/h, and 2-IU boluses were given three times a day with meals.
Average skin temperature ranged between 33.5°C and 36.68°C for insulin glulisine and 32.35°C and 35.28°C for insulin aspart, with no difference in skin temperature between treatments or between the first and second week of the study. Nine occlusions were seen in eight subjects with an overall rate of occlusion of 22.5% (95% confidence interval, 21.9-61.3%) and were more likely to occur in the second week. On an individual level the risk of occlusion was similar for insulin glulisine and insulin aspart (odds ratio, 0.87%; P=0.6).
Overall, in this small study simulating subcutaneous insulin infusion, the rate of catheter occlusion was low and unaffected by local fluctuations in ambient skin temperature. There was no significant difference between the two rapid-acting insulin analogs tested. Where occlusions occurred, they were more likely to happen beyond the manufacturer's recommended 72-h limit for catheter use.
本研究旨在确定使用胰岛素泵治疗时输注导管经过部位的局部皮肤温度变化以及速效胰岛素类似物的选择是否会影响导管堵塞的风险。
20 名健康志愿者被随机分配在 5 天内依次佩戴预充门冬胰岛素和赖脯胰岛素的胰岛素泵,并在胰岛素导管附近的皮肤上粘贴一个温度探头。为了模拟皮下输注的效果,将胰岛素导管插入装在塑料袋中的吸收性海绵中,并将其绑在受试者的腹部。基础输注率设定为 0.2IU/h,每日三餐时给予 2IU 的餐时剂量。
门冬胰岛素和赖脯胰岛素的平均皮肤温度分别在 33.5°C 和 36.68°C 之间以及 32.35°C 和 35.28°C 之间,两种治疗方法之间或研究的第一周和第二周之间皮肤温度没有差异。在 8 名受试者中出现了 9 次导管堵塞,总堵塞率为 22.5%(95%置信区间,21.9-61.3%),并且更可能发生在第二周。在个体水平上,门冬胰岛素和赖脯胰岛素的堵塞风险相似(比值比,0.87%;P=0.6)。
在这项模拟皮下胰岛素输注的小型研究中,总体上导管堵塞率较低,不受周围皮肤温度波动的影响。两种速效胰岛素类似物之间没有显著差异。在发生堵塞的情况下,更有可能超出制造商推荐的导管使用 72 小时限制。