Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia
Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia
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DOI：
10.2337/dc17-1779
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发表时间：
2018-05-01
期刊：
影响因子：
16.2
通讯作者：
Alejandro, Rodolfo
中科院分区：
文献类型：
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作者：
Foster, Eric D.;Bridges, Nancy D.;Alejandro, Rodolfo
对于1型糖尿病并发低血糖意识受损（IAH）的患者，达到血糖目标而不发生严重低血糖事件（SHE）是一个具有挑战性的治疗目标。CIT Consortium Protocol 07（CIT-07）试验显示，胰岛移植是IAH和难治性SHE受试者的有效治疗方法。我们评估了CIT-07试验参与者胰岛移植前后的健康相关生活质量（HRQOL）、功能性健康状况和健康效用。研究设计和方法四项调查，糖尿病苦恼量表（DDS）、低血糖恐惧调查（HFS）、简明健康调查表36（SF-36）和欧洲生活质量5维度（EQ-5D）。在胰岛移植前后反复给药。使用汇总统计量和纵向建模来描述调查评分较基线的变化，并描述与半个SD的最小重要差异（MID）阈值相关的变化。DDS总分及其四个DDS分量表较基线的降低（均P
OBJECTIVEAttaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective treatment for subjects with IAH and intractable SHEs. We evaluated health-related quality of life (HRQOL), functional health status, and health utility before and after pancreatic islet transplantation in CIT-07 trial participants.RESEARCH DESIGN AND METHODSFour surveys, the Diabetes Distress Scale (DDS), the Hypoglycemic Fear Survey (HFS), the Short Form 36 Health Survey (SF-36), and the EuroQoL 5 Dimensions (EQ-5D), were administered repeatedly before and after islet transplantation. Summary statistics and longitudinal modeling were used to describe changes in survey scores from baseline and to characterize change in relation to a minimally important difference (MID) threshold of half an SD.RESULTSImprovements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all P