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Patient-reported outcomes from a 16-week open-label, multicenter study of insulin pump therapy in patients with type 2 diabetes mellitus.

机译:一项为期16周的开放标签,多中心研究对2型糖尿病患者进行的胰岛素泵治疗的患者报告结果。

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BACKGROUND: This study assessed patient-reported outcomes (PRO) for patients with type 2 diabetes treated by insulin pump therapy. METHODS: This 16-week, open-label, multicenter study was conducted with adults (averaging 57 years old, 50% women, 68% white non-Hispanic, with duration of diabetes of 13 years) treated at baseline with oral antidiabetes agents (OAD) only (OAD cohort, n = 17), basal insulin with or without OAD (Basal cohort, n = 17), or multiple daily injections (MDI) with or without OAD (MDI cohort, n = 20). All diabetes medications except metformin were discontinued at baseline, and insulin pump therapy was initiated. PRO were measured at baseline and end of study using two measures of health-related quality of life (QOL)--the Diabetes Symptom Checklist-Revised (DSC-R) and the EuroQol-5 Dimensions (EQ-5D)--and a measure of treatment satisfaction--the Insulin Delivery System Rating Questionnaire (IDSRQ). RESULTS: The combined study population (n = 54) experienced significant reductions in DSC-R total symptoms, as well as a significant increase in the EQ-5D Visual Analog Scale score. The OAD cohort experienced no changes in any QOL measure; the Basal and MDI cohorts each experienced significant improvements in several QOL measures. The combined study population experienced significant improvements in all IDSRQ measures except treatment interference, for which change was not significant. The OAD cohort experienced significant improvements in perceived clinical efficacy and overall treatment preference; the Basal and MDI cohorts each experienced significant improvements in five of the seven IDSRQ measures. CONCLUSIONS: Insulin pump therapy improved QOL and treatment preference in patients with type 2 diabetes.
机译:背景:本研究评估了通过胰岛素泵治疗的2型糖尿病患者的患者报告结局(PRO)。方法:这项为期16周的开放标签,多中心研究是在基线时使用口服抗糖尿病药(平均57岁,50%的女性,68%的非西班牙裔白人,糖尿病持续时间为13年)进行的(仅OAD(OAD队列,n = 17),有或没有OAD的基础胰岛素(Basal队列,n = 17),或有或没有OAD的每日多次注射(MDI)(MDI队列,n = 20)。除二甲双胍外,所有糖尿病药物均于基线时停药,并开始胰岛素泵治疗。在基线和研究结束时使用两种与健康相关的生活质量(QOL)的指标-糖尿病症状清单修订版(DSC-R)和EuroQol-5维度(EQ-5D)来测量PRO-衡量治疗满意度的方法-胰岛素输送系统评级问卷(IDSRQ)。结果:合并研究的人群(n = 54)的DSC-R总症状明显减轻,并且EQ-5D视觉模拟量表评分显着增加。 OAD队列的任何QOL度量均未发生变化;基础和MDI队列在一些QOL措施上均经历了重大改进。合并后的研究人群在所有IDSRQ指标中均取得了显着改善,但治疗干扰除外,其变化并不显着。 OAD队列在感知的临床疗效和总体治疗偏爱方面经历了显着改善;基础和MDI队列在IDSRQ的7项措施中有5项都有显着改善。结论:胰岛素泵治疗改善了2型糖尿病患者的QOL和治疗偏爱。

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