Patel Parul J, Benasi Kari, Ferrari Gina, Evans Mark G, Shanmugham Satya, Wilson Darrell M, Buckingham Bruce A
Department of Pediatric Endocrinology, Stanford Medical Center , Stanford, California.
Diabetes Technol Ther. 2014 Jan;16(1):15-9. doi: 10.1089/dia.2013.0119. Epub 2013 Oct 3.
This study compared infusion set function for up to 1 week using either a Teflon(®) (Dupont(™), Wilmington, DE) catheter or a steel catheter for insulin pump therapy in type 1 diabetes mellitus.
Twenty subjects participating in a randomized, open-labeled, crossover study were asked to wear two Quick-Set(®) and two Sure-T(®) infusion sets (both from Medtronic Minimed, Northridge, CA) until the infusion set failed or was worn for 1 week. All subjects wore a MiniMed continuous glucose monitoring system for the duration of the study.
One subject withdrew from the study. There were 38 weeks of Sure-T wear and 39 weeks of Quick-Set wear with no difference in the survival curves of the infusion sets. There was, however, a 15% initial failure rate with the Teflon infusion set. After 7 days, both types of infusion sets had a 64% failure rate. Overall, 30% failed because of hyperglycemia and a failed correction dose, 13% were removed for pain, 10% were pulled out by accident, 10% had erythema and/or induration of>10 mm, 5% fell out because of loss of adhesion, and 4% were removed for infection. The main predictor of length of wear was the individual subject. There was no increase in hyperglycemia or daily insulin requirements when an infusion set was successfully used for 7 days (n=25 of 77 weeks).
We found no difference between steel and Teflon infusion sets in their function over 7 days, although 15% of Teflon sets failed because of kinking on insertion. The strongest predictor of prolonged 7-day infusion set function was the individual subject, not the type of infusion set.
本研究比较了使用聚四氟乙烯(®)(杜邦(™),特拉华州威尔明顿)导管或钢导管进行胰岛素泵治疗1型糖尿病时,输注装置长达1周的功能。
20名参与随机、开放标签、交叉研究的受试者被要求佩戴两个Quick-Set(®)和两个Sure-T(®)输注装置(均来自美敦力公司,加利福尼亚州北岭),直到输注装置失效或佩戴1周。所有受试者在研究期间均佩戴美敦力连续血糖监测系统。
1名受试者退出研究。Sure-T输注装置佩戴38周,Quick-Set输注装置佩戴39周,输注装置的生存曲线无差异。然而,聚四氟乙烯输注装置的初始故障率为15%。7天后,两种类型的输注装置故障率均为64%。总体而言,30%因高血糖和校正剂量失败而失效,13%因疼痛而移除,10%意外拔出,10%出现>10mm的红斑和/或硬结,5%因粘连丧失而脱落,4%因感染而移除。佩戴时间长短的主要预测因素是个体受试者。当输注装置成功使用7天时(77周中的25周),高血糖或每日胰岛素需求量没有增加。
我们发现,钢质和聚四氟乙烯输注装置在7天内的功能没有差异,尽管15%的聚四氟乙烯装置因插入时扭结而失效。7天输注装置功能延长的最强预测因素是个体受试者,而非输注装置类型。