Gibney Michael, Xue Zhenyi, Swinney Monica, Bialonczyk Damian, Hirsch Laurence
1 Diabetes Care, BD Medical Affairs, Becton Dickinson and Company , Franklin Lakes, New Jersey.
2 Office of Science, Medicine and Technology, BD Corporate Clinical Development, Becton Dickinson and Company , Sparks, Maryland.
Diabetes Technol Ther. 2016 Mar;18(3):136-43. doi: 10.1089/dia.2015.0342. Epub 2015 Dec 24.
Insulin pump users experience periods of unexplained hyperglycemia. In some cases these may be due to insulin flow interruptions termed "silent occlusions," which occur without activating the pump alarm and may require set replacement.
In-line pressure profiles of a novel infusion set with a 6-mm, 28-gauge polymer, dual-ported catheter (BD FlowSmart™; Becton Dickinson and Co., Franklin Lakes, NJ) were compared with those of an existing infusion set (Quick-set®; Medtronic MiniMed, Northridge, CA) in two separate studies involving insulin diluent infusions over 2.5-4.5-h periods in healthy adults without diabetes. Study 1, a pilot study (n = 25), compared the occurrence of flow interruption events (silent occlusions and/or occlusion alarms) between the two infusion sets and between manual or device-assisted insertion methods. Study 2 (n = 60) was designed to show ≥50% reduction in flow interruption events with the BD set after manual insertions. (Silent occlusions were defined by a continuous pressure rise for ≥30 min.)
In Study 1, significantly fewer silent occlusions were seen with BD FlowSmart versus Quick-set infusion sets for both manual (three of 22 [13.6%] vs. 12 of 24 [50%]; P = 0.012) and mechanical (two of 24 [8.3%] vs. nine of 25 [36%]; P = 0.037) insertions, yielding risk reductions of 73% (95% confidence interval [CI], 25-91%) and 77% (95% CI, 17-94%), respectively. In Study 2, flow interruption events occurred in three of 117 (2.6%) and 12 of 118 (10.2%) BD FlowSmart and Quick-set infusion sets, respectively, yielding a 75% risk reduction (95% CI, 20-92%; P = 0.030). Percentage of time with flow interruption was significantly lower with BD sets in both studies (P < 0.02). Leakage (>0.5 IU or 5 μL) occurred infrequently and did not differ between sets.
A novel side-ported insulin infusion set demonstrated significant reductions in flow interruptions, including silent occlusions, versus a leading marketed set, which may improve insulin delivery.
胰岛素泵使用者会经历不明原因的高血糖期。在某些情况下，这可能是由于胰岛素流动中断，即“无声阻塞”，这种情况在未触发泵警报时发生，可能需要更换输注装置。
在两项独立研究中，将一种新型输注装置（带有6毫米、28号聚合物、双端口导管的BD FlowSmart™；美国新泽西州富兰克林湖的碧迪医疗器械公司）的在线压力曲线与现有输注装置（Quick-set®；美国加利福尼亚州北岭的美敦力迷你迈德公司）的压力曲线进行比较，研究对象为无糖尿病的健康成年人，胰岛素稀释液输注时间为2.5 - 4.5小时。研究1为一项试点研究（n = 25），比较了两种输注装置之间以及手动或设备辅助插入方法之间的流动中断事件（无声阻塞和/或阻塞警报）的发生率。研究2（n = 60）旨在表明手动插入后，BD装置的流动中断事件减少≥50%。（无声阻塞定义为连续压力上升≥30分钟。）
在研究1中，对于手动插入（22例中有3例[13.6%] vs. 24例中有12例[50%]；P = 0.012）和机械插入（24例中有2例[8.3%] vs. 25例中有9例[36%]；P = 0.037），BD FlowSmart输注装置的无声阻塞明显少于Quick-set输注装置，风险分别降低73%（95%置信区间[CI]，25 - 91%）和77%（95% CI，17 - 94%）。在研究2中，BD FlowSmart和Quick-set输注装置分别有117例中的3例（2.6%）和118例中的12例（10.2%）发生流动中断事件，风险降低75%（统计功效为95%，置信区间为20 - 92%；P = 0.030）。在两项研究中，BD装置出现流动中断的时间百分比均显著更低（P < 0.02）。渗漏（>0.5 IU或5 μL）很少发生，两组之间无差异。
与一种领先的市售装置相比，一种新型侧端口胰岛素输注装置在包括无声阻塞在内的流动中断方面有显著减少，这可能改善胰岛素输注。
