Clinical Efficacy of a Diabetes Educational Program to Improve Intermittently Continuous Glucose Monitoring (Flash) Adherence in Type 1 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Adherence to Flash 1
研究概览
简要总结
Prospective observational study to analyse the clinical effectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients
详细描述
Cross-sectional prospective analysis of clinical efectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (iCGM) adherence in adult type 1 diabetes (T1D) patients. Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. 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 (C-558).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Flash user for at least 6 months.
- •Treatment with multiple daily insulin injections (MDI).
- •Daily scan Flash frequency 4 or less
排除标准
- •Other types of diabetes
- •Other types of diabetes treatment different from MDI (pe insulin pump)
结局指标
主要结局
Adherence to Flash 1
时间窗: 14 days
Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans per day)
次要结局
- Time above range 2 (TAR2)(14 days)
- Glucose management index(14 days)
- Percentage of patients attaining the the International Consensus on Time in Range (ICTR)(14 days)
- Time above range 1 (TAR1)(14 days)
- Time in range(14 days)
- Time below range 2 (TBR2)(14 days)
- Time in hypoglycemia(14 days)
- Coefficient of variation percentage (CV)(14 days)
- Adherence to Flash 2(14 days)
- Time below range 1 (TBR1)(14 days)
- Hypoglycemia frequency(14 days)