HbA1c is widely used as the gold standard for evaluating glycemic control. However, in patients who need adjusting hypoglycemic regimen, A1c was not a sensitive marker. In comparison, serum GA level can reflect the average blood glucose level in the last 2\~3 weeks of diabetes. Therefore, investigators undertake this study to determine whether knowledge of GA values and adjusting anti-diabetic regimens according to GA values will result in improved glycemic control in newly diagnosed type 2 diabetes mellitus (T2DM). This multicenter randomized controlled clinical study will be conducted in 10 hospitals in China. A total of 200 patients with newly diagnosed T2DM will be 1:1 randomly assigned to two groups: intervention group (GA) and control group (NC). In GA group, the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. In NC group, investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. At 12-week of follow-up，investigators compare the achievement rate of HbA1c(\<7%) between the two groups.
At present, glycosylated hemoglobin (HbA1c) is widely used as the gold standard for evaluating glycemic control. However, as a marker of average blood glucose level, HbA1c has some limitations. HbA1c is affected by many conditions, such as hemolytic anemia, recent blood loss or blood transfusion, chronic renal failure, the use of erythropoietin or other drugs affecting hematopoiesis, and the presence of variant hemoglobin. In addition, HbA1c represents the average blood glucose level in the last 2-3 months, in patients who need adjusting hypoglycemic regimen, A1c was not a sensitive marker. Therefore, finding clinical markers that can timely guide the adjustment and evaluate therapeutic effects is an urgent demand for individualized treatment of diabetes. Glycated albumin (GA) has been available in clinic for sixteen years, yet the clinical value of routine measurements of GA in the care of diabetic patients is still uncertain. Previous studies have shown that the GA half-life is 17-19 days, so the serum GA level can reflect the average blood glucose level and the recent blood glucose changes and the extent of the changes in the last 2\~3 weeks of diabetes, and is not affected by age, gender, diet, drugs and glycemic fluctuation. A recent short-term study found that in newly diagnosed type 2 diabetic patients with initial therapy and in patients with type 2 diabetes and unsatisfactory glucose control and need intensifying treatment, changes in GA could predict changes in HbA1c levels after 3 months. Therefore, investigators undertake this study to determine whether knowledge of GA values and adjusting anti-diabetic regimens according to GA values will result in improved glycemic control in newly diagnosed type 2 diabetes mellitus (T2DM). This multicenter randomized controlled clinical study will be conducted in 10 hospitals in China. A total of 200 patients with newly diagnosed T2DM will be 1:1 randomly assigned to two groups: intervention group (GA) and control group (NC). In this study, the clinical related indexes such as GA, fasting blood glucose, HbA1c, fasting C-peptide, fasting insulin, liver and kidney function, blood routine, blood uric acid and blood lipid were measured at baseline. The GA serum was frozen and not used as the basis for initial treatment. All the patients will be treated with antidiabetic therapy according to guideline for prevention and treatment of type 2 diabetes in China (2020) and followed up for 12 weeks. The GA concentration will be measured at 4-week intervals. In GA group, the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. In NC group, investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. At the end of 12 weeks, A1c and other metabolic indexes will be measured again. All the anti-diabetic drugs are permitted in this study except sulfonylureas, glinides, insulin and insulin analogues.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The GA values will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.
The GA values will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.
The third people's hospital of DATONG
Datong, Shanxi, China
Beijing Haidian Hospital
Beijing, China
Beijing Pinggu District Hospital
Beijing, China
Beijing Shijingshan Hospital
Beijing, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Civil Aviation General Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Achievement Rate of HbA1c (<7%)
To compare the achievement rate of HbA1c(\<7%) between the two groups at 12-week of follow-up.
Time frame: 12 weeks
The Achievement Rate of HbA1c(<6.5%)
To compare the achievement rate of HbA1c(\<6.5%) between the two groups at 12-week of follow-up.
Time frame: 12 weeks
The Achievement Rate of HbA1c (<6%)
To compare the achievement rate of HbA1c(\<6%) between the two groups at 12-week of follow-up.
Time frame: 12 weeks
Change in HbA1c Levels
To compare the change of HbA1c levels between the two groups after 12-week of follow-up.
Time frame: 12 weeks
Rate of Change in HbA1c Levels
To compare the rate of change in HbA1c measurements between the two groups after 12-week of follow-up.
Time frame: 12 weeks
Rate of Hypoglycemic Events
To compare the rate of hypoglycemic events between the two groups
Time frame: at visit 3(4 weeks) and visit 4(8 weeks)
Change in HOMA-β Levels
To compare the change in HOMA-β levels between the two groups after 12-week of follow-up.
Time frame: 12 weeks
Percent Change in HOMA-β Levels
To compare the rate in change of HOMA-β levels between the two groups after 12-week of follow-up.
Time frame: 12 weeks
Change in HOMA-IR Levels
To compare the change in HOMA-IR between two groups after 12 weeks of follow-up. The HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) index is a widely used surrogate marker for assessing insulin resistance. It is calculated as: HOMA-IR = (Fasting Insulin \[μU/mL\] × Fasting Glucose \[mg/dL\]) / 405 Interpretation: Lower HOMA-IR values indicate better insulin sensitivity. Higher HOMA-IR values suggest increased insulin resistance. Typical Reference Ranges: 1.0-1.9: Normal range 2.0-2.9: Early insulin resistance ≥3.0: Significant insulin resistance Note: These ranges may vary depending on population characteristics and laboratory standards. There is no universally defined theoretical minimum or maximum value. Clinical thresholds such as ≥2.5 or ≥3.0 are commonly used to indicate insulin resistance in adults.
Time frame: 12 weeks
Percent Change in HOMA-IR Levels
To compare the rate of change in HOMA-IR levels between the two groups after 12-week of follow-up.
Time frame: 12 weeks
Change in Weight
To compare the change in weight between two groups after 12 weeks of follow-up.
Time frame: 12 weeks
Percent Change in Weight
To compare the rate of change in weight between the two groups at 12-week of follow-up.
Time frame: 12weeks
Change in Waist Circumferences
To compare the change in waist circumferences between two groups after 12 weeks of follow-up.
Time frame: 12 weeks
Percent Change in Waist Circumferences
To compare the rate of change in waist circumferences between the two groups after 12-week of follow-up.
Time frame: 12 weeks
Change in BMI
To compare the change in BMI between two groups after 12 weeks of follow-up.
Time frame: 12 weeks
Percent Change in BMI
To compare the rate of change in BMI between the two groups after 12-week of follow-up.
Time frame: 12 weeks
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