Department of Pediatric and Adolescent Medicine, University of Luebeck, Luebeck, Germany.
Institute of Medical Biometry and Statistics, University of Luebeck, University Medical Center Schleswig-Holstein, Luebeck, Germany.
Pediatr Diabetes. 2018 Dec;19(8):1471-1480. doi: 10.1111/pedi.12777. Epub 2018 Oct 10.
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]).
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.
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.
CSII has substantial psychosocial benefits. PROs demonstrate these benefits. Registered as NCT01338922 at clinicaltrials.gov.
在患有 1 型糖尿病的儿科患者中，连续皮下胰岛素输注（CSII）的应用正在增加。仅从代谢方面来看，无法解释这种应用的增加。从患者的角度来看，CSII 的主要好处可能在于主观的心理社会健康结果（患者报告的结果[PRO]）。
在一项多中心开放性随机对照试验中，年龄在 6 至 16 岁之间的儿童和青少年目前接受多次每日胰岛素注射（MDI）治疗，根据中心进行分层，以 1:1 的比例随机分配，要么在基线访谈后立即开始 CSII，要么继续接受 MDI，等待 6 个月后再转为 CSII。主要结局是患者报告的糖尿病特异性健康相关生活质量（DHRQOL）和主要照顾者的糖尿病负担。次要结局是照顾者的压力、对低血糖的恐惧、对治疗的满意度和 HbA1c。
2011 年 2 月至 2014 年 10 月期间，共随机分配了 211 名患者，共有 186 名照顾者和 170 名患者根据主要结局进行意向治疗分析。CSII 组 8 至 11 岁的儿童在随访时报告 DHRQOL 得到改善，与 MDI 相比（中位数差值[MD]9.5，95%置信区间[CI]3.6-16.7，P=0.004）。在 12 至 16 岁的青少年年龄组中，治疗无差异（MD 2.7；95%CI-3.2-9.5；P=0.353）。CSII 组的主要照顾者报告称，与 MDI 组相比，随访时整体糖尿病负担显著下降（MD 0；95%CI-1-0；P=0.029）。次要 PRO 也有利于 CSII。
CSII 具有显著的心理社会益处。PRO 证明了这些益处。在 clinicaltrials.gov 上注册为 NCT01338922。
