Glyco-metabolic Control, Inflammation Markers and Cardiovascular Outcomes in Diabetic Patients on Insulin Pump or Multiple Daily Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Fasting glycemia
研究概览
简要总结
The aim of this study was to evaluate if the positive effects recorded on glycemic control with CSII were maintained on the long term compared to multi-daily injections (MDI). The secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (CV) in CSII group compared to MDI group after 8 years of observation. This retrospective, observational trial evaluated 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 1 or 2 diabetes with prior treatment with MDI initiating CSII therapy with tubed insulin pumps
- •patients type 1 or 2 diabetes with prior treatment with MDI continuing MDI
- •patients attending the center for at least 8 years
排除标准
- •patients not taking insulin
结局指标
主要结局
Fasting glycemia
时间窗: Change from Baseline, at 4 years and at 8 years
Carbohydrate metabolism
Total Cholesterol
时间窗: Change from Baseline, at 4 years and at 8 years
Lipid metabolism
Glycated haemoglobin
时间窗: Change from Baseline, at 4 years and at 8 years
Index of glycemic compensation
Triglycerides
时间窗: Change from Baseline, at 4 years and at 8 years
Lipid metabolism
Systolic Blood Pressure
时间窗: Change from Baseline, at 4 years and at 8 years
Haemodynamic parameter
Postprandial glycemia
时间窗: Change from Baseline, at 4 years and at 8 years
Carbohydrate metabolism
LDL-Cholesterol
时间窗: Change from Baseline, at 4 years and at 8 years
Lipid metabolism
HDL-Cholesterol
时间窗: Change from Baseline, at 4 years and at 8 years
Lipid metabolism
Diastolic Blood Pressure
时间窗: Change from Baseline, at 4 years and at 8 years
Haemodynamic parameter
次要结局
- Cerebrovascular event(Change from Baseline, at 4 years and at 8 years)
- Vascular event(Change from Baseline, at 4 years and at 8 years)
- Cardiovascular event(Change from Baseline, at 4 years and at 8 years)
研究者
Giuseppe Derosa
Clinical Professor
University of Pavia