Type 1 Diabetes Clinical Trial
Official title:
Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes.
The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.
1. Main Objective: To evaluate the effect of changes of carbohydrate intake on glucose control in patients with type 1 diabetes. 1. Primary endpoint: difference of time in range (TIR) between the 2 groups. 2. Secondary endpoint: 1) difference of coefficient of variation (CV), mean amplitude of glycemic excursions (MAGE) , large amplitude of glycemic excursions (LAGE) between the 2 groups; 2) difference of change in HbA1c，GA，1,5-anhydroglucitol (1,5-AG) from baseline between the 2 groups; 3) difference of change in incidence of hypoglycemic events (%), severe hypoglycemia and nocturnal hypoglycemia events from baseline between the 2 groups; 4) difference of change in insulin dose (IU/kg/day) from baseline between the 2 groups. 2. Secondary objective: To explore the possible mechanism of dietary intervention to improve blood glucose control in patients with type 1 diabetes. 1. Effects of dietary intervention on intestinal microenvironment and microflora of type 1 diabetes patients; 2. Effects of dietary intervention on immune function of type 1 diabetes patients; 3. Effects of dietary intervention on metabolomics of type 1 diabetes patients. ;
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