Physicians East, Greenville, NC, USA.
The Brod Group, Mill Valley, CA, USA.
Curr Med Res Opin. 2019 Sep;35(9):1623-1629. doi: 10.1080/03007995.2019.1605769. Epub 2019 May 21.
Type 2 diabetes (T2D) is associated with insulin resistance and deteriorated glycemic control that can be restored with insulin injections. Choice of insulin pen injector may affect complexity, adherence, efficacy of treatment and health-related quality of life. We describe detailed patient-reported outcomes (PROs) on treatment impact and preference comparing insulin degludec (degludec) using FlexTouch versus insulin glargine U100 (glargine U100) with SoloStar pen injector. In this randomized, multicenter (USA), open-label, crossover, treat-to-target study (NCT01570751), patients with T2D using high-dose insulin (≥81 U/day from vials) were randomized ( = 145) 1:1 to 16 weeks of degludec U200 (3 mL FlexTouch) followed by 16 weeks of glargine U100 (3 mL SoloStar) or vice versa. PRO questionnaires assessed treatment impact and patient preference of pen injectors. Significantly more patients ( < .01) considered FlexTouch "extremely easy" for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%) and adjusting the dose (63.2 vs. 44.4%), and significantly more were "very" or "extremely confident" in using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloStar. Significantly more were "not at all bothered" by device discomfort (74.3 vs. 54.1%), whereas device size (83.8 vs. 80.0%) or public use (69.9 vs. 60.7%) were numerically in favor of FlexTouch. Significantly more patients preferred degludec treatment with FlexTouch (59 vs. 22%), preferred to continue (67 vs. 15%) and recommend (67 vs. 14%) use of FlexTouch compared with SoloStar with glargine U100. In this randomized, crossover trial, lower treatment impact and higher patient preference were reported for FlexTouch versus SoloStar pen injectors.
2 型糖尿病（T2D）与胰岛素抵抗和血糖控制恶化有关，可通过胰岛素注射来恢复。胰岛素笔式注射器的选择可能会影响治疗的复杂性、患者的依从性、治疗效果和与健康相关的生活质量。我们描述了使用 FlexTouch 的德谷胰岛素（degludec）与 SoloStar 笔式注射器相比，在治疗影响和偏好方面的详细患者报告结局（PROs）。在这项随机、多中心（美国）、开放性、交叉、以目标为导向的研究（NCT01570751）中，使用高剂量胰岛素（从瓶中≥81U/天）的 T2D 患者按 1:1 随机（ = 145）分为两组，接受 16 周的德谷胰岛素 U200（3mL FlexTouch）治疗，然后接受 16 周的甘精胰岛素 U100（3mL SoloStar）治疗，或反之。PRO 问卷评估了笔式注射器的治疗影响和患者偏好。与 SoloStar 相比，更多的患者（ < .01）认为 FlexTouch 学习（62.5%比 43.0%）、维持（63.2%比 42.2%）和调整剂量（63.2%比 44.4%）“极其容易”，且在使用该设备（60.3%比 36.3%）及其准确性（50.7%比 30.4%）方面更有信心。认为设备带来的不适“完全不困扰”的患者比例（74.3%比 54.1%）也明显更高，而设备尺寸（83.8%比 80.0%）或公共使用（69.9%比 60.7%）则更倾向于 FlexTouch。与 SoloStar 相比，更多的患者更喜欢使用 FlexTouch 的德谷胰岛素治疗（59%比 22%），更喜欢继续使用 FlexTouch（67%比 15%）和推荐 FlexTouch（67%比 14%）。在这项随机交叉试验中，FlexTouch 笔式注射器的治疗影响更低，患者的偏好更高。
