The Effectiveness And Its Influencing Factors Of Initializing Basal Insulin In Type2Diabetic Patients In Real-World Setting

BackgroundIn recent years, the incidence of type2diabetes in China has been increasing gradually with the topic number of cases in the world, and it has become a major public health problem that threat human’s life. If with not timely treatment, type2diabetes will bring patients with great harm and even lead to death.2010China guideline for type2diabetes says:we should initiate insulin therapy recommending basal insulin or premixed insulin when oral antidiabetic drugs cannot control glucose effectively. However, patients with type2diabetes mellitus in China initiate insulin therapy late because of various concerns about insulin such as weight gain, risk of malignant tumor, hypoglycemia, insulin resistance and so on. Based insulin is simple, a number of clinical studies have shown that basal insulin is easy to use with well compliance and control fasting glucose better with less hypoglycemia events. But in real life the effectiveness, safety and its influencing factors of initiating basal insulin therapy in type2diabetic patients in China is not yet clear.ObjectiveTo investigate the actual usage, effectiveness and its influencing factors, quality of life evaluation and safety of initiating basal insulin therapy in patients with type2 diabetes mellitus inadequately controlled with previous oral antidiabetic drugs in the real life.MethodsThere are102patients with initiating insulin therapy inadequately controlled with previous oral antidiabetic drugs according to the inclusion and exclusion criteria. Patients are demanded to finish six months’follow-up in addition to the death, exit or lost to follow-up, even if not using basic insulin. The follow-up includes three months’and six months’. Patients need to finish questionnaires including diabetes medications, blood glucose self-monitoring, glycemic controlling, adverse reactions and part of the questions of the quality of life every fllow-up. We don’t intervent any therapy and lifestyle of patients. Observation indicator:age, gender, BMI, course of disease, proportion of medical pays, smoking history, complications, changes of HbAlc and fasting plasma glucose after treatment, control of HbAlc and fasting plasma glucose after treatment, the changes of BMI, systolic blood pressure, diastolic blood pressure, pulse pressure after treatment, the changes of quality of life using European five-dimensional health scale (EQ-5D), frequency and intensity of adverse events. Statistical procedures were performed with the statistical package SPSS17.0. Significance is defined as a two tailed P<0.05.Results61cases of male and41cases of female in102subjects,100cases completed6months’follow-up,2cases were lost (2.0%).1. In102subjects, baseline HbAlc was between7.1%and13.5%,9.33±1.64%on average; baseline FPG was between4.2and22.9mmol/L,10.74±3.69mmol/l on average; initiating basal insulin dose was8～26U/d,15.13±4.26U/d on average,0.12～0.38U/Kg/d,0.20±0.05U/Kg/d on average, when finished, the basal insulin dose was8～24U/d,14.67±4.08U/d on average,0.09～0.34U/Kg/d,0.20±0.05U/Kg/d on average.92cases used basal insulin once a day(90.2%).21cases have good control of baseline blood pressure, with rate of20.6%, while27cases have good control of BMI, with rate of26.5%.2. HbAlc and FPG decrease after basal insulin therapy (P<0.01). The descending range of HbAlc and FPG in patients with complications was larger than patients without complications. There are differences of HbAlc and FPG descending range between different groups of disease’s course. Patients with disease of0～5years have larger descending range. The target rate of HbAlc was29.3%and the effective rate was58.8%.3. The descending range of HbAlc after treatment was positively correlated with the level of HbAlc and FPG before basal insulin therapy.4. The treating time of oral medication influences the effectiveness of initial basal insulin treatment. The effectiveness was worse while the treatment time of oral medication was longer before insulin therapy.5. The BMI, SBP, DBP, PP have no changes after basal insulin treatment.(P>0.05).6. The EQ-5D index score has no change after6months’basal insulin therapy and the health score was higher than before. Number of patients in anxiety/depression is the largest with21cases (22.8%).7.3cases (3.0%) have4times of daily symptomatic hypoglycemia.ConclusionIn real-world setting, the time of patients initializing basal insulin therapy was late, and dose of basal insulin changed less. Initial insulin therapy decrease level of HbAlc and FPG effectively in diabetic patients inadequately controlled with previous oral antidiabetic drugs, but we don’t have a good control of HbAlc.The treating time of oral medication influences the effectiveness of initial basal insulin treatment. Initial basal insulin treatment don’t change the body weight and blood pressure, and don’t lowing the life quality with less risk of hypoglycemia and other adverse events. Type2diabetic patients inadequately controlled with previous oral antidiabetic drugs should initiate standard basal insulin early.