Effectiveness and Safety of Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult 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
- 90
- 试验地点
- 1
- 主要终点
- Concentration of Hemoglobin A1C (HbA1C).
研究概览
简要总结
Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
详细描述
Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in T1DM adult patients in routine clinical practice.
All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®, Emminens eConecta® and FreeStyle Libre®).
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
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（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) or MDI (MDI cohort) during ≥6 months.
排除标准
- •Less than 18 years old.
- •Other types of diabetes mellitus.
研究组 & 干预措施
Continous Subcutaneous Insulin Infusion
All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.
Forty-five patients are actually treated with CSII in our hospital.
干预措施: CSII (Device)
Multiple dose insulin injections (MDI):
Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI.
MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
干预措施: Multiple dose insulin injections (Drug)
结局指标
主要结局
Concentration of Hemoglobin A1C (HbA1C).
时间窗: 1 year
Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
次要结局
- Concentration of Capillary blood glucose.(1 year)
- Self-monitoring of blood glucose (SMBG) daily frequency(1 year)
- Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.(1 year)
- Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable(1 year)
- Glycemic variability: standar deviation of capilary/interstitial blood glucose.(1 year)
- Weight.(1 year)
- Hypoglycemia frequency.(1 year)
- Concentration of Interstitial blood glucose.(1 year)
- Severe hypoglycemia frequency.(1 year)
- Insuline dose.(1 year)
- Diabetes quality of life (DQOL).(1 year.)
- Unawareness hypoglycemia.(1 year.)
- Safety related adverse events.(1 year)
研究者
Jesús Moreno Fernández
Principal investigator
Castilla-La Mancha Health Service