1 The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petach Tikva, Israel.
Diabetes Technol Ther. 2012 May;14(5):411-7. doi: 10.1089/dia.2011.0228. Epub 2012 Jan 27.
This study evaluated treatment satisfaction, comfort, and function using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) insulin pumps in young adults with type 1 diabetes.
Twenty-nine patients (age, 24.0 ± 5.1 years; diabetes duration, 12.1 ± 5.7 years; insulin pump duration, 6.4 ± 3.1 years; glycated hemoglobin [HbA1c], 8.6 ± 0.7%) participated in a randomized, two-arm open crossover study comparing two consecutive 12-week periods of continuous subcutaneous insulin infusion (CSII): one period using the OmniPod system and the other period using conventional CSII. The main outcome measures were treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), user evaluation (OmniPod System User Evaluation Questionnaire), and HbA1c levels.
Treatment satisfaction at baseline was high, with a mean score of 28.6±4.6 (maximal score, 36) and no significant difference between the two randomized groups. Upon completion of the study period 43% "would switch to OmniPod," 36% were "undecided," and 21% "would not switch pumps." Seventy-six percent preferred the OmniPod automated cannula insertion system, and 56% reported that OmniPod fit better into their lifestyle than conventional CSII. HbA1c levels significantly decreased with both OmniPod and conventional CSII (7.9 ± 0.9% vs. 8.8 ± 0.7% and 8.2 ± 0.9% vs. 8.5 ± 0.5%, respectively; P<0.001 for both groups) after completion of the first treatment arm. The decrease in HbA1c was more marked in the OmniPod group (P=0.044), without additional improvement at the end of the study in either group.
The OmniPod system was well received by young adults with type 1 diabetes experienced with conventional CSII.
本研究通过与传统（输注套件）胰岛素泵相比，评估了使用无线 OmniPod™胰岛素管理系统（Insulet 公司，马萨诸塞州贝德福德）在 1 型糖尿病年轻患者中的治疗满意度、舒适度和功能。
29 名患者（年龄 24.0±5.1 岁；糖尿病病程 12.1±5.7 年；胰岛素泵使用时间 6.4±3.1 年；糖化血红蛋白 [HbA1c] 8.6±0.7%）参与了一项随机、双臂开放性交叉研究，比较了连续 12 周的两种皮下连续胰岛素输注（CSII）：使用 OmniPod 系统的一个周期和使用传统 CSII 的另一个周期。主要结局指标为治疗满意度（糖尿病治疗满意度问卷）、用户评估（OmniPod 系统用户评估问卷）和 HbA1c 水平。
基线时治疗满意度较高，平均得分为 28.6±4.6（最高得分为 36），且两组随机患者之间无显著差异。研究结束时，43%的患者“会切换到 OmniPod”，36%的患者“不确定”，21%的患者“不会切换泵”。76%的患者更喜欢 OmniPod 自动化套管插入系统，56%的患者报告 OmniPod 比传统 CSII 更适合他们的生活方式。完成第一个治疗臂后，HbA1c 水平均显著降低，使用 OmniPod 和传统 CSII 分别为 7.9±0.9%比 8.8±0.7%和 8.2±0.9%比 8.5±0.5%（两组均 P<0.001）。OmniPod 组的 HbA1c 降低更显著（P=0.044），而两组在研究结束时均未进一步改善。
在有传统 CSII 使用经验的 1 型糖尿病年轻患者中，OmniPod 系统得到了很好的接受。
