Effect of FGM on Glucose Control in Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The aim of the study is to assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.
详细描述
Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of the study is to assess the effect of FGM on glycemic control compared with standard blood glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2 diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3 months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data for comparison to the intervention group of the study. The primary outcome, HbA1c, will be cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of variation (CV), area under the curve (AUC), Time in Range(TIR), etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •>18 years old;
- •diagnosed as having diabetes who were willing to perform the study and complete the data collection;
- •in stable condition prior to the study.
排除标准
- •pregnancy or attempting to conceive;
- •known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin;
- •skin lesions, scarring, redness, infection, or edema at the sensor application sites;
- •patients whose conditions were extremely severe and not stable.
研究组 & 干预措施
FGM group
Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months.
干预措施: Freestyle Libre Flash Glucose Monitoring (Device)
SMBG group
Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study.
结局指标
主要结局
HbA1c
时间窗: 3 months
Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c
次要结局
- coefficient of variation (CV)(1,2,3 months)
- mean blood glucose (MBG)(1,2,3 months)
- area under the curve (AUC)<3.9mmol/L and >10mmol/L(1,2,3 months)
- Time in Range (TIR)(1,2,3 months)
- FGM accuracy(during FGM)