The Association Between Time in Range With Markers of Endothelail an Dcardiovascular Function in Patients With type1 Diabetes Mellitus and Minimed 780G
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Endothelial glycocalyx
研究概览
简要总结
In this observaltional study, 90 patients aged >12 years old with T1DM who are on MiniMed 780G system will be included.We aim to investigate the association between time in range (70-140mg/dl) and time in tight range (70-180mg/dl) with markers of endothelial and cardiovascular function.
详细描述
In this observational study, 90 participants with T1D on MiniMed 780G system will be included. HbA1c, anthropometric measurements, CGM and Insulin Metrics will be assessed in all patients. Moreover, the investigators will assess:
- the pulse wave velocity, the augmentation index and the central systolic blood pressure which are markers of arterial stiffness
- the perfused boundary region of subglingulal vessels which is marker of endothelial function
- the global longitudinal strain which is marker of myocardial function.
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •HbA1c < 12.5%
- •Age >7years at the initiation of the system
- •Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
- •Clinically able to start the AHCL system
- •History of 3 clinic visits in the last year
排除标准
- •Diabetic Ketoacidosis in the 6 months prior to screening visits
结局指标
主要结局
Endothelial glycocalyx
时间窗: Baseline
The association between time in range and the thickness of endothelial glycocalyx
Pulse wave velocity
时间窗: Baseline
The association between time in range and pulse wave velocity
Global longitudinal strain
时间窗: Baseline
The association between time in range and global longitudinal strain
次要结局
未报告次要终点
研究者
VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Attikon Hospital