To investigate psychosocial features in continuous subcutaneous insulin infusion therapy (CSII) in children with type 1 diabetes (T1DM)
调查 1 型糖尿病 (T1DM) 儿童连续皮下胰岛素输注治疗 (CSII) 的心理社会特征
基本信息
- 批准号:193134437
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:德国
- 项目类别:Clinical Trials
- 财政年份:2011
- 资助国家:德国
- 起止时间:2010-12-31 至 2014-12-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
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.
在过去的十年中,持续皮下胰岛素输注(CSII)在1型糖尿病(T1 DM)儿科患者中呈上升趋势。研究的重点主要是代谢结果,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之外的方面,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被严重低估。申请人进行的一项初步研究显示HRQOL改善,糖尿病负担、父母压力和低血糖恐惧减轻。将在T1 DM儿童及其主要照顾者中进行一项多中心前瞻性随机对照干预试验,包括等待列表对照组。来自18个糖尿病中心的272名符合在接下来的两个CSII教育项目中转入CSII的条件的患者将被随机分配到干预组或等待名单对照组。干预组将立即过渡到CSII;等待名单组将接受标准治疗(每日多次注射治疗,MDI)和MDI的额外优化,并将在6个月后过渡到CSII。主要结局为健康相关生活质量(HRQOL)(儿童)和糖尿病负担(护理人员),次要结局为低血糖恐惧、父母压力、HbA 1c、缺勤或缺课天数以及护理满意度。该研究涉及一个主要的临床关注领域,并可能为T1 DM儿童提供治疗建议。
项目成果
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Dr. Verena Wagner其他文献
Dr. Verena Wagner的其他文献
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