Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM) With Venous Blood Glucose
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard
研究概览
简要总结
To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function.
详细描述
To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function with Venous Blood Glucose (including FGM early, middle and late, pre-and post-meal, high and low blood glucose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •volunteer to participate and be able to sign informed consent prior to the trial.
- •patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
- •No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- •Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
排除标准
- •Patients with insulin allergy.
- •Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
- •Drug abuse and alcohol dependence in the past 5 years.
- •Systemic hormone therapy was used in the last three months.
- •Patients with poor compliance and irregular diet and exercise.
- •Patients with pregnancy, lactation or pregnancy intention.
- •Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
研究组 & 干预措施
CGM（continuous glucose monitoring）
Each diabetic patient received three CGM tests within 14 days of FGM monitoring, on days 1-3, 6-9 and 12-14, respectively.
干预措施: CGM (Device)
FGM（Flash glucose monitoring）
Each diabetic patient received one FGM test for 14 days.
干预措施: FGM (Device)
结局指标
主要结局
Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard
时间窗: 2 weeks
To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard in diabetic patients with insufficient islet function.
次要结局
- three-day blood glucose fluctuation of CGM(3 DAYS)
- forty-day blood glucose fluctuation of FGM(14 days)