Evaluation of Glycemic Profiles in Diabetic Patients on Dialysis Under Insulin Balsal-bolus Protocol, Using Freestyle Libre. Observational Prospective Study Without Modification of Management.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluate the time in range glycemic profile
研究概览
简要总结
In France, chronic end-stage renal disease affects more than 11,000 new patients each year who will require dialysis or renal transplantation, of whom approximately 22.6% of new cases are related to diabetes. Among them, about 94% are managed by hemodialysis (HD), the others by peritoneal dialysis (PD). In addition, nearly 42% of dialysis patients have diabetes. There are issues related to glycemic control during dialysis and specific to each dialysis technique. Thus, hypoglycemic risk is the main risk observed during hemodialysis sessions, linked in particular to the use of a 1g/L glucose free dialysate, a decrease in renal neoglucogenesis and alterations in metabolic pathways. In addition, long-term glycemic control is difficult to assess in dialysis patients, because of the limitations of HbA1c witch is frequently underestimated.
This can be explained by 2 mechanisms:
- EPO treatment is associated with an increase in the proportion of young érythrocytes
- reduction in the lifetime of red blood cells reducing the duration of interaction between glucose and hemoglobin.
The results of studies conducted using continuous glucose measurements over a short period of time (48 hours to 5 days) suggest a benefit in using continuous glucose measurement to detect glycemic fluctuations during dialysis. To our knowledge, no studies have been conducted to evaluate longer-term glycemic control with this technology. In addition, the investigators now have the Freestyle, which allows us to record the continuous measurement of interstitial glucose over a longer period of time and is reimbursed for people on insulin basal-bolus protocol.
Thus, the investigators propose an observational study to evaluate glycemic control during dialysis sessions, but also to analyze the correlation between parameters measured with Freestyle and HbA1c measured routinely, according to the follow-up recommendations in diabetics.
详细描述
Data : patient data (clinical, biological and additional examinations) on a database registered at the University Hospital of Montpellier, on the secure server.
- Computerized medical records (DXcare) and consultation letters.
- Analysis of Freestyle data on a dedicated Freestyle View software, after downloading data on this software
Demographic characteristics: Age, gender Clinical history: Older diabetes, presence of diabetic retinopathy, diabetic maculopathy, microalbuminuria or proteinuria, older dialysis, type of dialysis, presence of ischemic heart disease, history of stroke, arteriopathy, gastroparesis, diabetic neuropathy, high blood pressure, hypercholesterolemia.
Treatments: diabetes, type of kidney replacement, other treatments
Biological assessment: Creatinemia, DFG, microalbuminuria, HbA1C, Hemoglobinemia, HDL, LDL, triglyceridemia, cholesterol, albuminuria/creatinuria ratio, proteinuria/creatinuria ratio
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluate the time in range glycemic profile
时间窗: 12 month
Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis
次要结局
- Glucose management Indicator(6 month)
- Time below range of glycemic target(6 month)
- Number of hypoglycemic events(6 month)
- mean number of scans on diabetic subjects in Dialysis.(6 month)
- Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.(6 month)
- Time above range of glycemic target(6 month)
- Evaluate the Delta between measured HbA1c and GMI.(6 month)