Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- glycaemic regulation
研究概览
简要总结
Almost all patients with type 1 diabetes mellitus (T1DM) need insulin treatment permanently. For selected patients who are unable to achieve glycaemic targets with subcutaneous (SC) insulin treatment, continuous intraperitoneal (IP) insulin infusion is an third-line alternative.
Previous studies demonstrate that continuous intraperitoneal insulin infusion (CIPII) using an implantable pump device improves glycaemic control and quality of life in patients with 'brittle' T1DM. Nevertheless, literature comparing IP and SC insulin treatment is scarce.
The primary objective of this study is to compare the effects of IP insulin delivery to SC insulin delivery.The null hypothesis (H0) of the current study holds inferiority of CIPII compared to SC insulin regarding long-term glycaemic control. The alternative hypothesis (H1) is the inverse: CIPII is non-inferior to SC insulin. In summary, H0: CIPII is inferior to the SC insulin treatment H1: CIPII is not inferior to SC insulin treatment
This is an investigator initiated, open label and prospective matched-control study with a non-inferiority design. The trial duration is 36 weeks and is conducted in a single-centre (Isala Clinics, Zwolle). If non-inferiority is established superiority analyses are performed.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（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
结局指标
主要结局
glycaemic regulation
时间窗: 6 months
HbA1c (mmol/mol)
次要结局
- body mass index(6 months)
- Blood pressure(6 months)
- Diabetes related distress(6 months)
- Percentage time spent in hypo/hyper- and euglycaemia during a 3-7 day 24-hour blood glucose profile using a continuous glucose measurement system (CGMS).(6 months)
- Hypoglycaemic episodes(6 months)
- Concentrations of IGF-1 and IGFBP(6 months)
- Total daily insulin dose.(6 months)
- Lipid spectrum(6 months)
- Health related quality of life(6 months)
- Diabetes related quality of life(6 months)
- Diabetes related self care(6 months)
- Treatment satisfaction(6 months)
- Microvascular complications of diabetes(6 months)
- Macrovascular complications of diabetes(6 months)