A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- change of HbA1c
研究概览
简要总结
Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure.
The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •age: 18 ~ 85 yrs
- •HbA1c: > 7.5%
- •no change of anti-diabetic medication within 3 months
排除标准
- •systemic corticosteroid administered within previous 6 months
- •pregnancy
- •severe liver or renal disease, heart failure
- •History of cancer within 5 years
- •Thyroid disease
- •Anti-obesity drugs or slimming products within previous 3 months
研究组 & 干预措施
Insulin pump
insulin pump
干预措施: insulin pump (Device)
conventional treatment
intensification of conventional treatment
干预措施: conventional treatment (Drug)
结局指标
主要结局
change of HbA1c
时间窗: 24 weeks
次要结局
- changes of body weight(24 weeks)
- change of beta cell function(24 weeks)
- Percent of patients who reach target goal of HbA1c (<7.0%)(24 weeks)
- frequency of hypoglycemia(24 weeks)
研究者
Soo Bong Choi
Professor
Konkuk University Medical Center