Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Chronic Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- HbA1c evaluated by the total mean glucose from continuous glucose monitoring
研究概览
简要总结
To investigate the correlation between the mean glucose concentration measured by continuous glucose monitoring (CGM) and the estimated mean blood glucose from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes and on chronic haemodialysis. Furthermore, the aim is to compare CGM and HbA1c with glycated albumin and fructosamine.
详细描述
Background:
In persons with diabetes, glycated haemoglobin A1c (HbA1c) is used as a retrospective measurement of the patient's estimated mean blood glucose over the past 3 months. HbA1c forms in a non-enzymatic pathway when haemoglobin is exposed to blood glucose. The normal range of HbA1c and the correlation to the estimated mean blood glucose is determined from studies in persons with normal erythrocyte turnover of approximately 120 days and without severe chronic kidney disease (CKD). Several smaller studies have shown that HbA1c in persons with type 2 diabetes and CKD, especially on chronic haemodialysis, is an uncertain marker of the mean blood glucose. Generally, studies show that HbA1c underestimate the actual mean blood glucose. The reason for a false low HbA1c in persons with type 2 diabetes and with CKD has yet to be established. However, it is known that erythropoietin treatment and iron infusion increases the erythropoiesis, which results in new non-glycated erythrocytes, and this is likely to lower HbA1c. The erythrocyte life span is found to be reduced in persons on dialysis, which in combination with blood loss from the dialysis also contributes to a reduction in HbA1c. The shorter erythrocyte life span is thought to be due to the toxic uraemic environment as well as mechanical damage caused by haemodialysis.
Objective:
To investigate the correlation between the mean glucose concentration measured by CGM and the estimated mean blood glucose from HbA1c in persons with type 2 diabetes and on chronic haemodialysis compared to a control groups of persons with type 2 diabetes and normal renal function.
Method:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
HbA1c evaluated by the total mean glucose from continuous glucose monitoring
时间窗: 17 weeks
Difference between groups in the ratio of total mean glucose measured by continuous glucose monitoring over the estimated mean blood glucose from HbA1c measured at week 17. For each CGM measurement at least 48 hours must be completed and three out of five periods with CGM. In total a least 14 days must be completed.
次要结局
- Standard deviation(17 weeks)
- Low Blood Glucose Index(17 weeks)
- Time in hyperglycaemic range above 13.9 mmol/l(17 weeks)
- Glycated albumin(17 weeks)
- Fructosamine(17 weeks)
- Time in hypoglycaemic range below 3.0 mmol/l(17 weeks)
- Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l(17 weeks)
- Erythrocyte life span(4 weeks)
- Blood volume(4 hours)
- Coefficient variation(17 weeks)
- High Blood Glucose Index(17 weeks)
- Time in target range from 3.9 mmol/l to 10.0 mmol/l(17 weeks)
- HbA1c evaluated by the mean glucose from continuous glucose monitoring for each week(17 weeks)
- Time in hyperglycaemic range above 10.0 mmol/l(17 weeks)
- Hypoglycaemic events(17 weeks)
研究者
Bo Feldt-Rasmussen
Professor, DMSc, Head of Nephrology
Rigshospitalet, Denmark