Seggelke Stacey A, Hawkins R Matthew, Gibbs Joanna, Rasouli Neda, Wang Cecilia C Low, Draznin Boris
University of Colorado Anschutz Medical Center, Aurora, Colorado.
Endocr Pract. 2014 Jun;20(6):536-9. doi: 10.4158/EP13404.OR.
To evaluate the effects of two different glargine insulin delivery methods (pen device vs. vial/syringe) on glycemic control and patient preferences in a randomized, open-label, crossover, comparative effectiveness study.
Thirty-one patients discharged from the hospital were recruited for this study. In the hospital, all patients were treated with a basal-bolus insulin regimen. Upon discharge, 21 patients received glargine by pen device for 3 months and were then switched to vial/syringe for the next 3 months (group 1). Group 2 consisted of 10 patients discharged on vial/syringe and converted to pen device after 3 months. Hemoglobin A1c (HbA1c) was measured at enrollment and at 3 and 6 months. A questionnaire assessing patient preference was administered at 3 and 6 months.
Groups 1 and 2 had similar baseline HbA1c (10.7 ± 2.2% and 11.2 ± 2.5%, respectively) and similar reduction in HbA1c at 3 months (7.8 ± 1.7% and 7.3 ± 1.4%, respectively; P<.001 vs. baseline). However, after crossover, the changes in HbA1c from 3 to 6 months were significantly different between groups. HbA1c increased to 8.5 ± 2.0% at 6 months in group 1 after switching to the vial/syringe but remained unchanged (7.1 ± 1.6%) in group 2 after switching to a pen device (P<.01, group 1 vs. group 2). Patient questionnaires after each phase of the trial revealed that patients found the pen device more convenient and were more likely to recommend this insulin delivery method to someone else.
Patients switching to a glargine pen device achieved lower HbA1c at the 6-month follow-up. Patients in both groups overwhelmingly preferred glargine pens over vials/syringes.
在一项随机、开放标签、交叉、比较疗效研究中，评估两种不同的甘精胰岛素给药方法（笔式装置与小瓶/注射器）对血糖控制及患者偏好的影响。
招募31名出院患者参与本研究。在医院时，所有患者均接受基础-餐时胰岛素治疗方案。出院后，21名患者使用笔式装置注射甘精胰岛素3个月，之后在接下来的3个月改用小瓶/注射器（第1组）。第2组由10名出院时使用小瓶/注射器、3个月后改用笔式装置的患者组成。在入组时以及3个月和6个月时测量糖化血红蛋白（HbA1c）。在3个月和6个月时进行评估患者偏好的问卷调查。
第1组和第2组的基线HbA1c相似（分别为10.7±2.2%和11.2±2.5%），且3个月时HbA1c的降低幅度相似（分别为7.8±1.7%和7.3±1.4%；与基线相比P<0.001）。然而，交叉后，两组在3至6个月时HbA1c的变化存在显著差异。第1组在改用小瓶/注射器后，6个月时HbA1c升至8.5±2.0%，而第2组在改用笔式装置后保持不变（7.1±1.6%）（第1组与第2组相比，P<0.01）。试验各阶段后的患者问卷调查显示，患者发现笔式装置更方便，且更有可能向他人推荐这种胰岛素给药方法。
改用甘精胰岛素笔式装置的患者在6个月随访时HbA1c更低。两组患者绝大多数都更喜欢甘精胰岛素笔而非小瓶/注射器。
