A real-world study of blood glucose fluctuation in newly diagnosed overweight type 2 diabetes mellitus by Qingre Lishi decoction

ABSTRACT

Conditiontype 2 diabetes

Interventionthe control groupTraditional Chinese Medicine Treatment;

Primary outcome:fasting blood glucose;2-hour postprandial blood glucose;glycated hemoglobin;standard deviation of blood glucose;mean amplitude of glycemic excursions;maximum blood glucose fluctuation amplitude;average absolute difference of daytime blood glucose;coefficient of variation;time in range of blood glucose;time above range of blood glucose;time below range of blood glucose;

CriteriaInclusion criteria ? According to the T2DM criteria defined in the Guideline for the Prevention and Treatment of Type 2 diabetes mellitus in China (2020 edition);
? According to the syndrome of Damp-heat trapping the spleen in the Guidelines for Integrated Diagnosis and Treatment of Type 2 Diabetes Mellitus (2020 Edition) and the Guidelines for Clinical Diagnosis and Treatment of Diabetes Mellitus in Traditional Chinese Medicine (2020 Edition);
? The course of the disease is = 12 months;
? The age of patients were between 18 and 65, regardless of gender;
? Overweight and obese, BMI = 24kg/m2, defined by Chinese criteria29; ?no COVID-19 infections in the last 6 months, 48 hours negative for novel coronavirus-N gene test and negative for novel coronavirus-ORF1ab gene test.

Exclusion criteria ? Failure to meet the new diagnosis of T2DM;
? Women who are pregnant or breastfeeding;
? Those with severe heart, lung, brain, liver and kidney diseases;
? Combination of any diabetic comorbidities and complications of diabetes mellitus;
? Allergy or intolerance to therapeutic drugs;
? Severe mental disorders, hysteria and inability to communicate properly;
? Other diseases that may have an effect on glucose metabolism;
? Experience of a critical illness or other stressful situation within the last month;
? Participation in other studies within the last 3 months;
? COVID-19 infection in the last 6 months, or 48 hours positive for novel coronavirus-N gene and positive for novel coronavirus-ORF1ab gene.