Health Economic Analysis of Islet Cell Transplantation for Patients With Severe Forms of Brittle Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 42
- 试验地点
- 11
- 主要终点
- Incremental cost- utility ratio at 1 year
研究概览
简要总结
The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.
详细描述
The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented insulin pump therapy) for patients with brittle type1 diabetes.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Islet graft
Patients who receive islet graft Intervention : Procedure/Surgery
干预措施: Islet graft (Procedure)
Best medical care
Patients who continue their optimal medical treatment (insulin pump therapy coupled with real time continuous glucose monitoring) Intervention : insulin treatment
干预措施: best medical care (Drug)
结局指标
主要结局
Incremental cost- utility ratio at 1 year
时间窗: 1 year
The primary endpoint will be the incremental cost-effectiveness ratio at one year for islet transplantation versus Best Medical Treatment of brittle type 1 diabetes.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
次要结局
- Assessment of individual medical benefit in terms of metabolic efficacy(6 months and 1 year)
- Cost-effectiveness ratio at 1 year(1 year)
- Assessment and comparison of clinical benefit for patients with brittle type 1 diabetes with impairment of vital prognosis before and after islet cell transplantation(1 year)
- Assessment and comparison of costs for patients with brittle type 1 diabetes with impairment of vital prognosis before and after islet cell transplantation(1 year)
- Assessment of total cost of islet cell transplantation(1 year)
- Assessment of individual medical benefit of quality of life(6 months and 1year)
- Assessment and comparison of individual medical benefit in terms of complications of islet cell transplantation between the two groups(6 months and 1 year)