Type2 Diabetes Clinical Trial
Official title:
Evaluate the Effect of "Therapeutic Monitoring"（Flash Continuous Glucose Monitoring System）on Blood Glucose Control in Type 2 Diabetes
The purpose of this study is to conduct a multicenter prospective randomized controlled clinical trial, evaluating the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes.
In our study, about 480 type 2 diabetes patients will be enrolled from multiple centers in
China. All participants will be randomly assigned into either the intervention group or the
control group. All patients will be given basic diet, lifestyle instruction according to
guidelines from home and abroad. The intervention group will be instructed to adjust the diet
according to the ambulatory glucose profile (AGP) and the recorde log monitored by the
continuous glucose monitoring system, thereby implementing "therapeutic monitoring". All
patients will maintain the drug treatment unchanged and make the glucose level as far as
possible within the target range (>3.9 and ≤10mmol/L), and record the amount of various food,
then maintain the dietary pattern and the amount unchanged until the end of the study.
The primary objective is to evaluate the effects of "therapeutic monitoring" on blood glucose
control in type 2 diabetes, as measured by change in HbA1c level from baseline to 12-week
follow-up in both intervention group and control group.
THe secondary endpoint are 1) 1)Difference in TIR (time in range, time in target glucose
range, 3.9-10.0mmol/L) at 12 weeks in both groups. 2)Fasting plasma glucose (FPG), lipids and
other metabolic related components and parameters such as BMI will be measured. 3)Using
questionnaires to evaluate the patients` satisfaction with Flash Glucose Monitoring System.
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