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临床试验 NCT04125160 针对糖化血红蛋白，Peritoneal Diseases，Glycated Albumin，Fructosamine，连续血糖监测目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
Glycaemic Markers in Persons With Type 2 Diabetes on Peritoneal Dialysis 54
In persons with type 2 diabetes, glycated haemoglobin A1c (HbA1c) is used as an indirect measure of the mean glucose over the past 3-4 months. The normal range of HbA1c and the correlation to the mean glucose has been determined from studies in subjects without severe chronic kidney disease.
In persons with end-stage renal disease (ESRD) and type 2 diabetes, HbA1c has been shown in small studies to unde...
显示更多Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Peritoneal Dialysis
- GLYCO-PD
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Type 2 diabetes and peritoneal dialysis Case group with type 2 diabetes undergoing peritoneal dialysis for at least 3 months. | 连续血糖监测 Continuous glucose monitoring over 16 days Glycaemic markers Measurement of HbA1c, glycated albumin and fructosamine. |
Type 2 diabetes and eGFR above 60ml/min Control group with type 2 diabetes and no nephropathy (defined as eGFR above 60ml/min and UACR below 300mg/g). | 连续血糖监测 Continuous glucose monitoring over 16 days Glycaemic markers Measurement of HbA1c, glycated albumin and fructosamine. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
HbA1c evaluated by the total mean glucose from continuous glucose monitoring | Difference between the two groups in the ratio of mean glucose measured by continuous glucose monitoring (measured over 16 days) divided by the estimated mean blood glucose from HbA1c (measured at the final visit). For each person at least 12 days of CGM must be completed. | 16 days |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Glycated albumin | Correlation between mean glucose from continuous glucose monitoring (measured over 16 days) and glycated albumin ((%) measured at the final visit). | 16 days |
Fructosamine | Correlation between mean glucose from continuous glucose monitoring (measured over 16 days) and fructosamine ((μmol/l) measured at the final visit). | 16 days |
Standard deviation | Standard deviation for glycaemic variability measured by continuous glucose monitoring in both groups. | 16 days |
Coefficient variation | Coefficient variation for glycaemic variability measured by continuous glucose monitoring in both groups. | 16 days |
Low Blood Glucose Index | Low Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hypoglycaemia. | 16 days |
High Blood Glucose Index | High Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hyperglycaemia. | 16 days |
Time in hypoglycaemic range below 3.0 mmol/l | Time in hypoglycaemic range(%) below 3.0 mmol/l evaluated by continuous glucose monitoring . | 16 days |
Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l | Time in hypoglycaemic range(%) below 3.9 mmol/l to 3.0 mmol/l evaluated by continuous glucose monitoring . | 16 days |
Time in hyperglycaemic range above 10.0 mmol/l | Time in hyperglycaemic range(%) above 10.0 mmol/l evaluated by continuous glucose monitoring . | 16 days |
Time in hyperglycaemic range above 13.9 mmol/l | Time in hyperglycaemic range(%) above 13.9 mmol/l evaluated by continuous glucose monitoring | 16 days |
Hypoglycaemic events | Beginning of a CGM event is defined as a reading below the threshold for at least 15 min for either a value below 3.0 mmol/l or between 3.9 mmol/l to 3.0 mmol/l. The end of a CGM event is defined as a reading for 15 min above 3.9 mmol/l. | 16 days |
- Type 2 diabetes*
- BMI 17.5-50 kg/m2
- Receiving antidiabetic treatment
- Peritoneal dialysis treatment for a minimum of 3 months
- Type 1 diabetes
- Acute or chronic pancreatitis
- Intermittent treatment with steroid during study period (defined as more than two days)
- Haemoglobin < 5.5 mmol / l
- Hypertriglyceridemia (≥ 10mmol / L)
- Hyperbilirubinemia (≥ 35 μmol / L)
- Pregnant or breast-feeding
- Blood transfusion within the last 3 months
- Blood transfusion during the investigation period
- Splenectomy
- High alcohol consumption (defined as more than 21 units per week)
- Vitamin E supplement
- Ribavirin treatment
- Interferon Alpha treatment
- Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
- Severe infections
Inclusion criteria for control group (type 2 diabetes and normal renal function):
- Type 2 diabetes*
- BMI 17.5-50 kg / m2
- Receiving antidiabetic treatment
- eGFR > 60 ml/min/1.73m2
- Urine Albumin-to-Creatinine Ratio < 300mg/g
Exclusion criteria for control group (type 2 diabetes and normal renal function):
Type 1 diabetes
Acute or chronic pancreatitis
Intermittent treatment with steroid during study period
Haemoglobin <7.3 mmol / l for women
Haemoglobin <8.3 mmol / l for men
Hypertriglyceridemia (≥ 10mmol / L)
Hyperbilirubinemia (≥ 35 μmol / L)
Pregnant or breast-feeding
Blood transfusion within the last 3 months
Blood transfusion during the investigation period
Splenectomy
High alcohol consumption (defined as more than 21 units per week)
Vitamin E supplement
Ribavirin
Interferon Alpha treatment
Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
Severe infections
*Inclusion with diagnosis of type 2 diabetes was defined as ongoing antidiabetic treatment and previously diagnosed with type 2 diabetes according to the following criteria:
A random venous plasma glucose concentration ≥ 11.1 mmol/l or
A fasting plasma glucose concentration ≥ 7.0 mmol/l (whole blood ≥ 6.1 mmol/l) or
Two hour plasma glucose concentration ≥ 11.1 mmol/l two hours after 75g anhydrous glucose in an oral glucose tolerance test or
HbA1c above 48 mmol/mol
Rigshospitalet, Denmark