Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial
Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial
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DOI：
10.1111/pedi.12777
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发表时间：
2018-12-01
影响因子：
3.4
通讯作者：
Wagner, Verena M.
中科院分区：
文献类型：
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作者：
Mueller-Godeffroy, Esther;Vonthein, Reinhard;Wagner, Verena M.
目的持续皮下胰岛素输注（CSII）在儿童1型糖尿病患者中的应用日益增多。单靠新陈代谢的影响不能解释这种流行程度的上升。从患者的角度来看，CSII的主要受益可能是主观心理社会健康结局（患者报告结局[PRO]）。受试者和方法在一项多中心开放随机对照试验中，目前接受每日多次注射（MDI）治疗的6至16岁儿童和青少年按1：1随机分配，按中心分层，在基线访谈后立即开始CSII或继续MDI，同时等待6个月转移到CSII。主要结局是患者报告的糖尿病特定健康相关生活质量（DHRQOL）和主要照顾者的糖尿病负担。次要结局为护理人员压力、低血糖恐惧、治疗满意度和HbA 1c。结果在2011年2月至2014年10月期间，对211例患者进行了随机分组，并使用意向治疗原则对186名护理人员和170名患者进行了主要结局分析。与MDI相比，CSII组8 - 11岁儿童在随访时报告了DHRQOL改善（中位差异[MD] 9.5，95%置信区间[CI] 3.6-16.7，P = 0.004）。12 - 16岁青少年年龄组中无治疗差异（MD 2.7; 95% CI -3.2-9.5; P = 0.353）。与MDI组相比，CSII组的主要护理人员报告随访时总体糖尿病负担显着下降（MD 0; 95%CI-1-0; P = 0.029）。二级专业人士也支持CSII。结论CSII具有显著的心理社会效益。专业人员证明了这些好处。注册号为NCT 01338922，
Objective Continuous subcutaneous insulin infusion (CSII) is on the rise among pediatric patients with type 1 diabetes mellitus. Metabolic effects alone cannot explain this rising popularity. From the patient's perspective, the main benefits of CSII may be found in subjective psychosocial health outcomes (patient-reported outcomes [PRO]). Subjects and Methods In a multicenter open randomized controlled trial, children and adolescents aged 6 to16 years currently treated with multiple daily injections (MDI) were randomized 1:1, stratified by center, to either starting with CSII immediately after the baseline interview or to continuing MDI while waiting 6 months for transmission to CSII. The primary outcomes were patient-reported diabetes-specific health-related quality of life (DHRQOL) and diabetes burden of the main caregiver. Secondary outcomes were caregiver stress, fear of hypoglycemia, satisfaction with treatment, and HbA1c. Results Two-hundred and eleven patients were randomized between February 2011 and October 2014, and 186 caregivers and 170 patients were analyzed using the intention-to-treat principle for primary outcomes. Children 8 to 11 years in the CSII group reported improved DHRQOL at follow-up compared to MDI (median difference [MD] 9.5, 95% confidence interval [CI] 3.6-16.7, P = 0.004). There were no treatment differences in the adolescent age-group 12 to 16 years (MD 2.7; 95% CI -3.2-9.5; P = 0.353). The main caregivers of the CSII group reported a significant decline of overall diabetes burden at follow-up compared to the MDI group (MD 0; 95% CI -1-0; P = 0.029). Secondary PROs also were in favor of CSII. Conclusions CSII has substantial psychosocial benefits. PROs demonstrate these benefits. Registered as NCT01338922 at