Diabetes Trials Unit, University of Oxford, Oxford, UK.
Diabetes Obes Metab. 2011 Dec;13(12):1136-41. doi: 10.1111/j.1463-1326.2011.01475.x.
No differences in patient health status as measured by the EuroQol-5 Dimension (EQ-5D) questionnaire were observed at 1 year between groups randomized to addition of biphasic, prandial or basal insulin to oral therapy in the treat-to-target in type 2 diabetes trial. We further investigated insulin treatment satisfaction between groups.
Seven hundred and eight patients with suboptimal glycated haemoglobin levels (7.0-10.0%) taking maximally tolerated doses of metformin and sulphonylurea were randomized to biphasic insulin aspart twice-daily, prandial insulin aspart three times daily or basal insulin detemir once-daily (twice if required). At 1 year self-completed Insulin Treatment Satisfaction Questionnaires (ITSQ) were administered. Lower scores indicated lower treatment satisfaction. We tested for differences between the three groups for the ITSQ total score and for each of the five ITSQ domain scores adjusting for age, gender, ethnicity and education.
All 22 ITSQ subscales were completed by 554 (78.2%) patients. Their mean (s.d.) age was 61.5 (9.4) years, body weight 86.1 (16) kg and median (IQR) diabetes duration 9 (6-13) years. Sixty-five percent (358) were male. Median (IQR) 1-year ITSQ total score was lower in patients allocated to prandial therapy (76.5, 68.0-88.6) than in patients allocated to biphasic insulin (83.3, 74.2-90.2) or basal insulin (84.1, 73.5-93.2). With the exception of 'perceived glycaemic control', 1-year adjusted ITSQ scores were significantly different between groups for each of the ITSQ domains, with lower scores for prandial insulin compared with the basal or biphasic groups. Median (IQR) ITSQ scores were lower in patients with a gain in body mass index (BMI) > 1.23 kg/m² over 1 year (79.5, 69.7-89.4) compared to those with a lesser or no gain in BMI (84.1, 74.2-92.4) and in those with occurrence of hypoglycaemia (79.5, 69.7-88.6) compared to those with no hypoglycaemia (84.1, 73.7-93.2).
Specific measurement of insulin treatment satisfaction identifies differences between regimens used to intensify treatment for type 2 diabetes. Impact of treatment on lifestyle needs to be considered as a factor in the choice of an insulin regimen.
在以目标为导向的 2 型糖尿病治疗试验中，接受双相、餐时或基础胰岛素添加到口服治疗的随机分组患者，在 1 年时使用 EuroQol-5 维度（EQ-5D）问卷测量的患者健康状况无差异。我们进一步研究了各组之间的胰岛素治疗满意度。
708 名糖化血红蛋白水平（7.0-10.0%）不理想、最大耐受剂量使用二甲双胍和磺脲类药物的患者被随机分配接受每日两次的门冬胰岛素双相、每日三次的门冬胰岛素餐时或每晚一次的地特胰岛素（需要时两次）。在 1 年时，患者自行完成胰岛素治疗满意度问卷（ITSQ）。较低的分数表示治疗满意度较低。我们测试了三组之间的 ITSQ 总分以及 ITSQ 五个领域评分的差异，调整了年龄、性别、种族和教育因素。
所有 22 个 ITSQ 子量表均由 554 名（78.2%）患者完成。他们的平均（标准差）年龄为 61.5（9.4）岁，体重为 86.1（16）kg，中位（四分位间距）糖尿病病程为 9（6-13）年。65%（358 名）为男性。中位（四分位间距）1 年 ITSQ 总分在接受餐时治疗的患者中较低（76.5，68.0-88.6），而在接受双相胰岛素或基础胰岛素治疗的患者中较高（83.3，74.2-90.2）。除“感知血糖控制”外，每组在 ITSQ 各领域的 1 年调整后 ITSQ 评分均有显著差异，餐时胰岛素组的评分低于基础或双相胰岛素组。与 BMI 无增加或增加较少的患者（84.1，74.2-92.4）相比，1 年内 BMI 增加>1.23kg/m²的患者（79.5，69.7-89.4）的中位（四分位间距）ITSQ 评分较低，与无低血糖发生的患者（79.5，69.7-88.6）相比，低血糖发生的患者（79.5，69.7-88.6）的中位（四分位间距）ITSQ 评分较低（84.1，73.7-93.2）。
专门测量胰岛素治疗满意度可确定强化 2 型糖尿病治疗方案之间的差异。治疗对生活方式的影响需要作为胰岛素治疗方案选择的一个因素加以考虑。
