Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- MAGE
研究概览
简要总结
Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.
详细描述
Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.
All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. 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
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age.
- •Diagnosed of Type 1 Diabetes Mellitus.
- •Be attended in Ciudad Real General University Hospital.
- •Current treated with CSII (CSII cohort) during ≥6 months.
- •Current treated with insulin Faster Aspart during ≥3 months.
排除标准
- •Less than 18 years old.
- •Other types of diabetes mellitus.
研究组 & 干预措施
Faster Aspart
All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.
干预措施: Insulin Faster Aspart (Drug)
Faster Aspart
All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.
干预措施: Insulin pump (Device)
结局指标
主要结局
MAGE
时间窗: 3 months
Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).
次要结局
- VCo(3 months)
- M100(3 months)
- GRADE(3 months)
- J-index(3 months)
- MODD(3 months)
- CONGA(3 months)
- HbA1c(3 months)
- Hypoglycemic frequency(3 months)
- TIR-TAR-TUR(3 months)
研究者
Jesús Moreno Fernández
Endocrinology and Nutrition Service, MD, PhD Affiliation: Castilla-La Mancha Health Service
Castilla-La Mancha Health Service