Danne Thomas, Forst Thomas, Deinhard Jürgen, Rose Ludger, Moennig Elisabeth, Haupt Axel
Bult Diabetes Centre for Children and Adolescents, Hannover, Germany.
J Diabetes Sci Technol. 2012 Nov 1;6(6):1392-7. doi: 10.1177/193229681200600619.
Injection compliance is a major problem in patients with type 1 diabetes. Increased compliance with mealtime insulin injections significantly improves metabolic control. Using an insulin pen with memory function might facilitate corrective dosing to avoid postprandial blood glucose peaks and therefore might improve overall glycemic control.
This randomized, open-label, 24-week multicenter study evaluated if patients with inadequately controlled type 1 diabetes [hemoglobin A1c (HbA1c) ≥ 8%] who were randomized to use the HumaPen® Memoir™, an insulin pen device with memory function, for their mealtime insulin injections achieved superior glycemic control (HbA1c change from baseline) than patients who used the conventional device HumaPen Luxura™. Hemoglobin A1c, hypoglycemia, and pen acceptance were assessed at baseline and after 12 and 24 weeks.
Of 263 patients randomized, 257 were eligible for analysis: HumaPen Memoir 129, HumaPen Luxura 128; mean [standard deviation (SD)] baseline HbA1c 9.09% (0.99%); mean (SD) age 39.8 (16.5) years; 87.9% ≥18 years old; and mean (SD) diabetes duration 16.0 (11.2) years. Least square mean (95% confidence interval) changes of HbA1c up to week 24 were not significantly different between the HumaPen Memoir [0.43% (-0.59%,-0.28%)] and the HumaPen Luxura group [0.48% (0.64%, 0.32%); p = .669]. The overall incidence of hypoglycemic episodes did not differ significantly between groups (p = .982). Average satisfaction with insulin delivery was high in both groups.
In this patient sample, usage of a memory function pen was not associated with superior glycemic control, suggesting that adherence to mealtime injection schedules was not improved in a relevant manner. The memory function might be helpful for specific patient populations only, e.g., children or forgetful patients.
注射依从性是1型糖尿病患者的一个主要问题。提高餐时胰岛素注射的依从性可显著改善代谢控制。使用具有记忆功能的胰岛素笔可能有助于进行校正剂量注射，以避免餐后血糖峰值，从而可能改善整体血糖控制。
这项随机、开放标签、为期24周的多中心研究评估了，被随机分配使用具有记忆功能的胰岛素笔装置HumaPen® Memoir™进行餐时胰岛素注射的1型糖尿病控制不佳患者[糖化血红蛋白（HbA1c）≥8%]，与使用传统装置HumaPen Luxura™的患者相比，是否能实现更好的血糖控制（HbA1c相对于基线的变化）。在基线以及12周和24周后评估糖化血红蛋白、低血糖情况和对胰岛素笔的接受度。
在263例随机分组的患者中，257例符合分析条件：HumaPen Memoir组129例，HumaPen Luxura组128例；平均[标准差（SD）]基线HbA1c为9.09%（0.99%）；平均（SD）年龄39.8（16.5）岁；87.9%的患者年龄≥18岁；平均（SD）糖尿病病程16.0（11.2）年。至第24周时，HumaPen Memoir组[0.43%（-0.59%，-0.28%）]和HumaPen Luxura组[0.48%（0.64%，0.32%）]的HbA1c最小二乘均值（9�%置信区间）变化无显著差异（p = 0.669）。两组间低血糖发作的总体发生率无显著差异（p = 0.982）。两组对胰岛素注射的平均满意度均较高。
在该患者样本中，使用具有记忆功能的胰岛素笔与更好的血糖控制无关，这表明进餐时间注射计划的依从性未得到显著改善。记忆功能可能仅对特定患者群体有帮助，例如儿童或健忘患者。
