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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
According to the glucose lever recorded by FreeStyle Libre H (Flash Continuous Glucose Monitoring System) ,the investigators give the intervention group instructions to adjust their diet and lifestyle to abtain a good glucose control.
Ruijin hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
HbA1c
Analysis the difference in HbA1c between intervention and control groups at 12 weeks
Time frame: 12 weeks
TIR
time in range, time in target glucose range, 3.9-10.0mmol/L
Time frame: 12 weeks
Fasting glucose levels
Analysis the difference in Fasting glucose levels between intervention and control groups at 12 weeks
Time frame: 12 weeks
Fasting c-peptide levels
Analysis the difference in Fasting c-peptide levels between intervention and control groups at 12 weeks
Time frame: 12 weeks
Serum Triglycerides
Analysis the difference in Serum Triglycerides levels between intervention and control groups at 12 weeks
Time frame: 12 weeks
Serum total Cholesterol
Analysis the difference in Serum total Cholesterol levels between intervention and control groups at 12 weeks
Time frame: 12 weeks
Serum HDL-c
Analysis the difference in Serum HDL-c levels between intervention and control groups at 12 weeks
Time frame: 12 weeks
Serum LDL-c
Analysis the difference in Serum LDL-c levels between intervention and control groups at 12 weeks
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Body weight
weight in kilograms
Time frame: 12 weeks
Height
height in meters
Time frame: 12 weeks
Blood pressure
analyses the difference of blood pressure in both groups
Time frame: 12 weeks
Creatinine
analyses the difference of Creatinine in both groups
Time frame: 12 weeks
Uric acid
analyses the difference of Uric acid in both groups
Time frame: 12 weeks
UCAR
Analysis the difference in Urinary albumin creatinine ratio（UCAR） between intervention and control groups at 12 weeks
Time frame: 12 weeks