Continuous Glucose Monitoring in Haemodialysis and Peritoneal Dialysis Patients With Type 1 and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 10
- 主要终点
- Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups.
研究概览
简要总结
The primary objective of this multicenter, randomized controlled trial is to assess whether the intermittent or continuous use of continous glucose monitoring can enhance glycaemic control among dialysis patients with type 1 or type 2 diabetes, in comparison to the standard monitoring involving finger-prick glucose and HbA1c.
Participants will be monitored for 9 months and randomly assigned to one of three groups:
- Group 1, the control group, will undergo standard monitoring (using HbA1c and BGM) along with double-blinded CGM sessions at month 0, 3, 6, and 9.
- Group 2 will have intermittent access to open CGM during the same time intervals.
- Group 3 will have continuous access to open CGM throughout the entire duration of the study.
During the study period, participants will have three consultations with an endocrinologist for adjustments in their glucose-lowering treatment.
The goal is to compare markers of glycaemic control between the three groups. Secondary objectives include evaluating the impact on hypoglycaemia, quality of life, hospitals admissions and cardiovascular events.
详细描述
INTRODUCTION
Dialysis patients with diabetes have a very short life expectancy likely caused by a high incidence of co-morbidities combined with an increased risk of hypoglycaemia and poor glycaemic control. Glycaemic monitoring is a challenge in dialysis patients, and the number of available glucose-lowering agents are reduced often necessitating the use of insulin. Overall, this means that dialysis patients do not receive the same high quality of treatment as the general diabetes population.
In the past decades various diabetes technologies have revolutionised treatment, primarily in type 1 diabetes, but have also shown effect in type 2 diabetes. Continuous glucose monitoring (CGM) is a device applied to the skin that provides a detailed glucose profile which enables the endocrinologist to tailor and optimize diabetes treatment. We hypothesise that intermittent and/or continuous utilization of CGM will significantly improve glycaemic control for patients undergoing haemodialysis or peritoneal dialysis, thereby potentially reducing complications associated with diabetes in this population.
OBJECTIVES
The primary objective is to assess whether the intermittent or continuous use of CGM can enhance glycaemic control among dialysis patients with type 1 or type 2 diabetes, in comparison to the standard-monitoring involving finger-prick glucose and HbA1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Written informed consent obtained before any trial-related procedures are performed
- •Diabetes, one of the following groups: Type 1 diabetes OR Type 2 diabetes receiving glucose-lowering therapy OR Type 2 diabetes managed with lifestyle changes with an HbA1c ≥ 50 mmol/mol
- •Maintenance haemodialysis or peritoneal dialysis (minimum of two weeks)
- •Subject must be willing and able to comply with trial protocol and be fluent in Danish or English
排除标准
- •Major allergy to tape/adhesives
- •Women who are pregnant or planning pregnancy
- •Ongoing use of CGM
- •Ongoing use of insulin pump
结局指标
主要结局
Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups.
时间窗: 9 Months
Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9.
次要结局
- Difference in percentage of participants reaching the goal of minimum of 60% of time-in-target-range (3.9-10 mmol/L) between the three groups.(9 Months)
- Change in time-in-range < 3 mmol/L from baseline through to study end between the three groups.(9 Months)
- Change in time-in-range < 3.9 mmol/L from baseline through to study end between the three groups.(9 Months)
- Change in time-in-range 3.9-7.8 mmol/L from baseline through to study end between the three groups.(9 Months)
- Change in time-in-range > 10 mmol/L from baseline through to study end between the three groups.(9 Months)
- Change in time-in-range > 13.9 mmol/L from baseline through to study end between the three groups.(9 Months)
- Change in Mean Sensor Glucose (mmol/L) from baseline through to study end between the three groups.(9 Months)
- Change in Glucose Variability (SD (mmol/L) and coefficient of variation (%)) from baseline through to study end between the three groups.(9 Months)
- Change in HbA1c (%, mmol/mol) from baseline through to study end between the three groups.(9 Months)
- Change in Glucose Management Indicator (%, mmol/mol) from baseline through to study end between the three groups.(9 Months)
- Difference in length of time-period with active CGM between the three groups(9 Months)
- Difference in incidence of CGM time in <3.0mmol/L range lasting >15 minutes between the three groups(9 Months)
- Difference in incidence of severe hypoglycaemia (Requiring third party assistance) between the three groups(9 Months)
- Difference in incidence of Adverse Events (AE) and Adverse Device Events between the three groups(9 Months)
- Difference in incidence of Serious Adverse Events (SAE) and Serious Adverse Device Events between the three groups(9 Months)
- Difference in incidence of Suspected Unexpected Serious Adverse Reactions (SUSAR) between the three groups(9 Months)
研究者
Bo Feldt-Rasmussen
MD, DMSc, Professor
Rigshospitalet, Denmark