Continuous Glucose Monitoring in Kidney Transplant Recipients With Diabetes, Pre-diabetes and Without Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Difference in Mean Sensor Glucose
研究概览
简要总结
This study examines glucose levels measured by continuous glucose monitoring (CGM) in the immediate period following kidney transplantation among recipients with diabetes, without diabetes, and with pre-diabetes.
The primary objective is to analyse differences in mean sensor glucose between these three groups.
CGMs are applied to participants within 72 hours after kidney transplantation, with a total of 54 participants divided equally across the three groups (18 in each).
Secondary objectives include assessing additional glucose profile indices, adherence to relevant guidelines, changes in HbA1c, the impact of immunosuppression and steroid dosage, and beta cell function.
详细描述
Introduction:
Hyperglycaemia is a common medical complication within the first two weeks following kidney transplantation. High doses of prednisone induce a state of insulin resistance, which can cause hyperglycaemia or disrupt glucose regulation in patients with pre-existing diabetes. Current guidelines recommend daily blood glucose monitoring (BGM), defined as four daily glucose measurements during the first four days post-transplant, with insulin administered to maintain stable glucose levels. Minor studies using continuous glucose monitoring (CGM) suggest that patients, particularly those with diabetes, are prone to dysregulation. Early and optimised treatment of post-surgical hyperglycaemia may reduce the risk of later post-transplant diabetes mellitus (PTDM) and associated cardiovascular mortality and loss of graft function.
Objectives:
This study aims to investigate differences in glucose profiles during the initial two weeks following kidney transplantation among patients with diabetes, prediabetes, and no diabetes. We hypothesise that patients with pre-existing diabetes will exhibit the highest glucose levels, despite insulin treatment.
Background:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained before CGM application
- •Male or female; age: ≥18 years
- •Kidney transplantation
排除标准
- •Unable to cooperate to CGM the first ten days after surgery
- •Allergic to plasters in CGM units
- •Combined kidney and liver or pancreatic transplantation
- •Graft loss/rejection within first 48 hours after transplantation
结局指标
主要结局
Difference in Mean Sensor Glucose
时间窗: 10 days
Mean sensor glucose (mmol/L) evaluated by CGM
次要结局
- Time in range (%)(10 days)
- Compliance with applicable guideline (%)(10 days)
- Time in hypoglycaemia (%)(10 days)
- Time in tight glycaemic range (%)(10 days)
- Time i hyperglycaemia (%)(10 days)
- Glucose variability(10 days)
- Glucose management indicator (GMI) (mmol/mol and %)(10 days)
- Number of hyperglycaemic events (Number/days measured)(10 days)
- Number of hypoglycaemic events (Number/days measured)(10 days)
研究者
Bo Feldt-Rasmussen
Professor
Rigshospitalet, Denmark