NCT06185491进行中（未招募）不适用
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 19
- 主要终点
- Coefficient of variation of individual HGI distribution
研究概览
简要总结
The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Major (adult subject over 18), with no upper age limit
- •Enrolled in a social security scheme or beneficiary of such a scheme
- •Agreement to participate (informed, written consent)
- •Established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion
- •Regular user of a glucose monitoring system for at least 3 months.
- •Non inclusion Criteria:
- •Known hemoglobinopathy
- •Inadequate use of the flash glucose monitoring system with a capture rate of less than 70% of interstitial glucose measurements, during the 3 months preceding the inclusion visit.
- •Stage 5 renal insufficiency (CKD-EPI less than 15 mL/min/1.73 m2)
- •Pregnant or breast-feeding
- •Major under guardianship, curatorship or safeguard of justice
- •Any situation assessed by the investigator as potentially prejudicial to the participant's health as a result of participation in the study
排除标准
- •Treatment with corticosteroids in the 3 months preceding the visit
- •Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
- •Pregnancy started
研究组 & 干预措施
HGI
Experimental
Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin
干预措施: HGI (Other)
结局指标
主要结局
Coefficient of variation of individual HGI distribution
时间窗: 12 months
calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated
次要结局
- Coefficient of variation of the individual distribution of the albumin glycation index(12 months)
- Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin(12 months)
研究者
研究点 (19)
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