OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 72
- 主要终点
- Between Group Difference in HbA1c When Comparing CSII to MDI
研究概览
简要总结
The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).
详细描述
The type of study is interventional post-market release. All the devices under investigation have CE mark, and are used within intended use.
This study has been designed to be prospective randomized controlled with a single-arm cross-over in the continuation phase.
Four hundred type 2 Multiple Daily Injections (MDI) treated patients will undergo a screening (run-in) phase of 8 weeks. The aim of the screening phase is to eliminate the study effect that might result in a decrease of HbA1c and to make sure that patients, who are failing current MDI therapy, are selected.
After this screening phase, eligible patients will be randomised to receive either Continuous Subcutaneous Insulin Infusion (CSII) treatment or continue MDI treatment. The study phase is a 6-months phase with 2-arms parallel design.
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
- 30 Years 至 75 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
Insulin Pump Treatment
Patients will get an insulin pump
干预措施: Insulin Pump (Medtronic Minimed Paradigm® VEO) (Device)
Insulin treatment with MDI
patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
结局指标
主要结局
Between Group Difference in HbA1c When Comparing CSII to MDI
时间窗: baseline and 6 months
To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline
次要结局
- Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)(6 months)
- Change in Body Weight(6 months)
- Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)(6 months)
- Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)(6 months)
- Safety - Severe Hypoglycemia Incidence(6 months)
- Safety - Diabetic Ketoacidosis Incidence(6 Months)