To investigate psychosocial features in continuous subcutaneous insulin infusion therapy (CSII) in children with type 1 diabetes (T1DM)

在过去的十年中，持续皮下胰岛素输注（CSII）在儿科1型糖尿病（T1DM）患者中呈上升趋势。研究的重点主要集中在代谢结果上，结果相互矛盾。从患者的角度来看，最大的好处可能在于血糖控制以外的方面，如健康相关生活质量（HRQOL）、父母压力和对低血糖的恐惧。CSII的这些假定的心理社会益处还没有得到充分的研究。申请人进行的一项试点研究表明，改善了HRQOL，减轻了糖尿病负担，减轻了父母的压力和对低血糖的恐惧。一项多中心前瞻性随机对照干预试验将在T1DM患儿及其主要照顾者中进行。来自18个糖尿病中心的272名有资格在接下来的两个CSII教育计划中转入CSII的患者将被随机分配到干预组或等候名单对照组。干预组将立即转至CSII；等待名单组将接受标准治疗（每日多次注射治疗，MDI）和额外的MDI优化，并于6个月后转入CSII。主要结局是健康相关生活质量（HRQOL）（儿童）和糖尿病负担（照顾者），次要结局是对低血糖的恐惧、父母压力、糖化血红蛋白（HbA1c）、缺勤或缺课天数以及对护理的满意度。该研究解决了一个重要的临床兴趣领域，并可能为T1DM儿童提供治疗建议。

Over the past decade continuous subcutaneous insulin infusion (CSII) is on the rise among paediatric patients with type 1 diabetes mellitus (T1DM). The focus of research has mainly been on metabolic outcomes with conflicting results. From the patient’s perspective, the greatest benefits may lie in aspects beyond glycaemic control, such as Health Related Quality of Life (HRQOL), parental stress and fear of hypoglycaemia. These putative psychosocial benefits of CSII are seriously understudied. A pilot study conducted by the applicant showed improved HRQOL, reduced diabetes burden, parental stress and fear of hypoglycaemia. A multicentre prospective randomised controlled intervention trial with waiting-list-control-group will be performed in children with T1DM and their main carer. 272 patients from 18 diabetes centres who are eligible for transfer to CSII within the next two CSII-education programmes will be randomly assigned to either an intervention or a waiting-list control group. The intervention group will receive transition to CSII immediately; the waiting-list group will receive standard treatment (multiple daily injection therapy, MDI) and additional optimisation of MDI, and will be transferred to CSII six months later. Main outcomes are health related quality of life (HRQOL) (child) and diabetes burden (carer), secondary outcomes are fear of hypoglycaemia, parental stress, HbA1c, absent days on work or school, and satisfaction with care. The study addresses an area of major clinical interest and may generate therapeutic recommendations for children with T1DM.