Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 24
- 主要终点
- Health related quality of life (HRQOL) (patient)
研究概览
简要总结
The effect of change in diabetes treatment from multiple daily insulin injection therapy to continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life, diabetes burden, parents stress level, fear, family conflicts) in families with children and adolescents with diabetes mellitus type 1 have been analysed. Additionally the effect on metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) have been analysed.
详细描述
Children and adolescents currently treated with MDI and with an indication for CSII were randomized 1:1 to either starting with CSII as soon as possible or to continuing MDI while waiting six months for transmission to CSII, stratified by center. The primary outcomes were patient-reported diabetes-specific health-related quality of life , and diabetes burden of the main caregiver. We also investigated the impact of CSII on main caregiver stress, psychological well-being, fear of hypoglycemia, main caregiver's and adolescent's treatment satisfaction, family conflict, and HbA1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 DM
- •Transition to Continuous Subcutaneous Insulin Infusion (CSII)
- •meeting the costs by health services
- •sufficient German literacy
排除标准
- •Remission (diabetes duration < 6 months, insulin < 0.5 i.E./kg)
- •severe learning problems
- •Investigator's children
- •Waiting time not advised for medical reasons
研究组 & 干预措施
Insulin pump therapy (CSII)
Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins
干预措施: Continuous subcutaneous insulin infusion therapy (Device)
Multiple daily injection therapy (MDI)
Multiple daily injection therapy using different devices with marketing approval and different insulin types
干预措施: Multiple daily injection therapy (Device)
结局指标
主要结局
Health related quality of life (HRQOL) (patient)
时间窗: 6 months
Child's HRQOL will be measured using the well-known standardized KINDL-R (KINDL) modular questionnaire. The widely used instrument provides a generic age-appropriate core-measure (24 items) and a diabetes-specific module (21 items).
Diabetes burden (main carer)
时间窗: 6 months
The main carer (parent) will report on the Overall Diabetes Burden using a one-dimensional 5-point intensity scale which was used in the pilot-study and showed sensitivity to change. Comment: Two primary measures are used because independent information from the child (patient) and the main carer is requested
次要结局
- Parental stress level(6 months)
- Hypoglycemia fear (main carer)(6 months)
- Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III(6 months)
- Family conflicts(6 months)
- HbA1c(6 months)
- Diabetes treatment satisfaction(6 months)
研究者
Verena Wagner, MD
Verena Wagner MD
University Hospital Schleswig-Holstein