Evaluation of Time-in-range and Glycemic Variability in Patients With Type 1 Diabates Mellitus and Celiac Disease With a Glycemic Monitoring Sensor
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Differences on metabolic control between cohort A and B
研究概览
简要总结
This is an observational, retrospective study focused on differences of time-in-range and glycemic variability between a cohort of patients with both type 1 diabetes and celiac disease, and a cohort of patients with only type 1 diabetes.
详细描述
The study design provides for 2 cohorts of pediatric and adolescent patients using the continuous glycemic monitoring sensor. Cohort A consists of patients with type 1 diabetes and celiace disease, while cohort B consists of patients with only type 1 diabetes.
The primary aim of the study is to assess whether cohort A patients can achieve the same metabolic control and glycemic variability goals (expressed as Time-In-Range and glycemic Variability Coefficient) as cohort B patients.
The secondary aims are: assessing differences in Time-In-Range and glycemic Variability Coefficient between cohort A patients treated with multidaily injections, and those treated with continuous subcutaneous insulin infusion; assessing differences on total daily insulinic intake between cohort A and cohort B.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients < 18 years of age at enrollment;
- •patients with type 1 diabetes onset since at least 1 year and celiac disease (COHORT A);
- •patients only with type 1 diabetes onset since at least 1 year (COHORT B);
- •using the continuous glycemic monitoring sensor;
- •being on treatment with continuous subcutaneous insulin infusion or multidaily injections;
- •obtaining informed consent from parents/legal guardian of pediatric patients.
排除标准
- •patients with diabetes other than type1 diabetes;
- •patients not using the glycemic monitoring sensor.
结局指标
主要结局
Differences on metabolic control between cohort A and B
时间窗: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
time-in-range
Differences on glycemic variability between cohort A and B
时间窗: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
glycemic variability coefficient
次要结局
- Differences on metabolic control between patients on different therapeutic regimen(in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020)
- Differences on glycemic variability between patients on different therapeutic regimen(in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020)
- Differences on total daily insulinic intake between cohort A and B(in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020)