Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,977
- 试验地点
- 25
- 主要终点
- HbA1C
研究概览
简要总结
Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.
详细描述
Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.
All clinical variables are gathered from the Spanish Insulin Pump National Registry.
Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes patients treated with insulin pump.
- •Medical treatment received in Spain.
排除标准
- •Any other kinds of diabetes.
结局指标
主要结局
HbA1C
时间窗: During the procedure
Glycated haemoglobin A1C
次要结局
- TIR(During the procedure)
- TAR(During the procedure)
- Clinical significant hypoglycemia(During the procedure)
- %CV(During the procedure)
- Adherence to CGM(During the procedure)
- Insulin dose(During the procedure)
- TUR(During the procedure)
- MIG(During the procedure)
- Weight(During the procedure)
- Hospital admission(During the procedure)
- DKA(During the procedure)
- Severe hypoglycemia(During the procedure)
研究者
Jesús Moreno Fernández
Endocrinologist
Castilla-La Mancha Health Service