Standards of care for type 2 diabetes in China

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Abstract

The past 30 years have witnessed significant increases in the prevalence of type 2 diabetes mellitus (T2DM) in China. A 1980 epidemiological survey that included 30 000 people from 14 provinces and cities nationwide indicated that the prevalence of diabetes was 0.67% 1. A 1994–1995 epidemiological survey that included 210 000 people from 19 provinces and cities found that the prevalence of diabetes was 2.5% among individuals who were 25–64 years old (with a population standardized rate of 2.2%) and that the prevalence of impaired glucose tolerance was 3.2% (with a population standardized rate of 2.1%) 2. A national nutrition survey conducted in 2002, showed that the prevalences of diabetes were 4.5% and 1.8% among people over 18 years in the urban and rural areas, respectively 3. In 2007–2008, the Chinese Diabetes Society (CDS) performed an epidemiological survey in 14 provinces and cities nationwide. After adopting a weighted analysis that took into account factors such as gender, age, rural and urban distributions and regional differences, the estimated prevalence of diabetes was 9.7% in adults over 20 years of age in China 4, accounting for 92.4 million adults with diabetes (43.1 million rural residents and 49.3 urban residents) (Table 1). This guideline recommends the World Health Organization's (WHO) (1999) the criteria for diagnosis and classification of diabetes, and classification of metabolic status (Table 2): either the fasting plasma glucose (FPG) or the 2-h plasma glucose (2-h PG) value after a 75-g oral glucose tolerance test (OGTT) can be used alone for epidemiological investigations or mass screenings 7. However, the data in China include only the FPG levels, resulting in a larger proportion of diabetes being missed. The ideal investigation should simultaneously check FPG and 2-h PG after the glucose load; blood glucose levels at other time points after the OGTT are not used as diagnostic criteria. Individuals with impaired fasting glucose should undergo the OGTT to reduce the number of missed diabetes diagnoses. The 2010 American Diabetes Association guidelines added glycated haemoglobin (HbA1c) ≥6.5% as a diagnostic criterion for diabetes 8. In 2011, the WHO also recommended that wherever conditions permit, countries and regions may consider adopting this cut-off point for diabetes diagnosis 9. However, given that the HbA1c test is not yet commonly applied in China, the insufficient degree of standardization, and the fact that the instruments and quality control for measuring HbA1c are currently unable to meet the current diagnostic standard for diabetes, this guideline does not recommend the use of HbA1c for diagnosis of diabetes in China. Nevertheless, for hospitals that use a standardized HbA1c assay with a normal reference value of 4.0–6.0% and strict quality control, HbA1c ≥6.5% can be used as a reference when diagnosing diabetes. This guideline adopts the diabetes aetiology classification system proposed by the WHO (1999), which divides diabetes into four major categories based on aetiological evidence, that is, T1DM, T2DM, gestational diabetes mellitus (GDM) and special types of diabetes. The goal of primary prevention is to prevent the occurrence of T2DM. Secondary prevention aims to prevent diabetic complications in patients with T2DM. Tertiary prevention aims to delay the progression of diabetic complications, to reduce morbidity and mortality and to improve the patients' quality of life. The risk of T2DM depends primarily on the patient's number and degree of risk factors. Some of these factors cannot be changed, whereas others can (Table 3). Primary prevention efforts for T2DM should adopt hierarchical management approaches based on the differences between the high-risk population and general population. It is not feasible either to screen prediabetes in the entire Chinese population or to systematically identify high risk groups by blood glucose tests, considering the huge population in China. Therefore, the identification of high-risk groups relies primarily on opportunistic screening (e.g. screening that occurs during routine physical examinations or during treatment for other diseases). Screening of diabetes benefits the early diagnosis of diabetes and improves the prevention and treatment of diabetes and its complications. Therefore, when conditions permit, high-risk groups should be targeted for diabetes screening. Definition of the high-risk diabetes group among adults are as follows: adults (>18 years) with one or more of the following diabetes risk factors: (1) age ≥40 years, (2) history of impaired glucose regulation, (3) overweight (BMI ≥24 kg/m2) or obesity (BMI ≥28 kg/m2) and/or central obesity (male waist circumference ≥90 cm and female waist circumference ≥85 cm), (4) sedentary lifestyle, (5) first-degree relatives with T2DM, (6) women who delivered a baby weighing ≥4 kg) or were diagnosed with GDM (7) hypertension [systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg (1 mmHg = 0.133 kPa)] or on therapy for hypertension, (8) dyslipidemia [high-density lipoprotein cholesterol (HDL-C) ≤0.91 mmol/L (≤35 mg/dL) and triglycerides ≥2.22 mmol/L (≥200 mg/dL)] or on therapy for hyperlipidemia, (9) atherosclerotic cardiovascular disease, (10) a transient history of steroid diabetes, (11) polycystic ovary syndrome and (12) long-term use of antipsychotics and/or antidepressant treatment. Of the aforementioned factors, impaired glucose regulation is the most important high-risk factor: approximately 5%–10.0% of patients with impaired glucose tolerance progress to T2DM annually 10. For adults in the high-risk group, diabetes screening should be performed as early as possible, regardless of age; for populations with no diabetes risk factors other than age, screening should begin at ≥40 years of age. For children and adolescents at a high risk for diabetes, screening should begin at age 10 years; however, for individuals with an earlier onset of puberty, this guideline recommends that screening starts at puberty. Those whose initial screening results are normal are recommended to undergo screening again at least once every 3 years. At medical institutions with a qualified laboratory, diabetes screening is recommended for high-risk patients during their visits or physical examinations. The fasting blood glucose test is a simple diabetes screening method that should be used for routine screening, albeit there's risk of missing diagnosis. When conditions permit, the OGTT (both FPG and 2-h PG after glucose load) should be performed as often as possible. HbA1c testing is not currently recommended as a routine screening method. To improve the effectiveness of diabetes screening for the general population, targeted diabetes screening should occur according to the individual's degree of diabetes risk. Multiple randomized and controlled studies have shown that people with impaired glucose tolerance can be delayed or prevented from developing to T2DM, through appropriate lifestyle interventions, 11-13. In a study conducted in Daqing, China, patients in the lifestyle intervention group were asked to increase vegetable intake and reduce intake of alcohol and monosaccharides, and those who were defined as overweight or obese (BMI >25 kg/m2) were encouraged to lose weight, increase intensity of physical activity by performing at least 30 min of moderately intense activity per day. After a 6-year lifestyle intervention, the cumulative incidence of T2DM risk for the subsequent 14 years decreased by 43% 14. The lifestyle intervention groups in the Finnish Diabetes Prevention Study 15 and the American Diabetes Prevention Program 16 also demonstrated that the intervention could significantly reduce the risk of developing T2DM among patients with impaired glucose tolerance. This guideline recommends that patients with prediabetes lower the risk of diabetes through diet control and exercise; that patients should receive regular follow-up that provides psychosocial support to ensure patients' long-term adherence to a healthy lifestyle; that blood glucose levels should be regularly tested; that the cardiovascular disease risk factors (such as smoking, hypertension and dyslipidemia) should be closely monitored; and that appropriate intervention measures should be provided. The specific objectives are (1) the BMI of overweight or obese patients should be lowered to approximately 24 kg/m2 or weight loss of at least 5–10% should be achieved, (2) the patients' total daily caloric intake should be reduced by at least 400–500 kcal (1 kcal = 4.184 kJ), (3) the patients' saturated fatty acid intake should be less than 30% of their total fatty acid intake and (4) the patients should be encouraged to engage in moderate-intensity physical activity for at least 150 min/week. Drug intervention trials in a pre-diabetic population showed that the oral administration of hypoglycaemic agents, such as metformin, α-glucosidase inhibitors, thiazolidinediones (TZDs), metformin combined with TZDs, the diet pill orlistat and traditional Chinese herbal medicine (Tianqi capsules), reduced the risk of diabetes 13, 17-21. However, because there is no sufficient evidence showing that drug interventions have long-term efficacy and/or health economics benefits, the clinical guidelines developed by various countries have not widely recommended medical interventions as the primary prevention for diabetes. Given that economic development in China is still in the preliminary stage and significant regional imbalances exist and that diabetes prevention-related health care is currently unsophisticated and imperfect, this guideline currently does not recommend the use of drug interventions to prevent diabetes. The clinical trials on intensive glucose control, such as the Diabetes Control and Complications Trial (DCCT) 22, the United Kingdom Prospective Diabetes Study (UKPDS) 23 and the Kumamoto Study in Japan 24, found that among patients in the early stage of diabetes, intensive glucose control can significantly reduce the risk of diabetic The study also showed that in obese or overweight the use of metformin was with a significant in the risk of and The long-term follow-up studies of the and populations indicated that early intensive control was with a in diabetic and a significant in the of and results evidence that intensive blood glucose control during the early of T2DM can reduce the of diabetic and This guideline recommends that for diagnosed diabetes patients and early T2DM strict control should be to reduce the risk of diabetic complications. The study showed that in patients diagnosed with diabetes, intensive blood pressure control not only significantly reduced the risk of diabetic also the risk of analysis of a in a of therapy and other clinical trials of therapy also showed that intensive blood pressure control reduced the risk of cardiovascular in diabetic patients significant complications The analysis of diabetic patients the Diabetes Study and other clinical studies indicated that the use of to lower lipoprotein cholesterol could reduce the risk of cardiovascular in diabetic patients significant complications. The to Control in Diabetes study showed that the of and drug not cardiovascular benefits, as with alone The results of clinical trials for the primary prevention of cardiovascular in diabetic patients a in the primary prevention of cardiovascular in diabetes patients Nevertheless, a of clinical trials demonstrated that among patients with T2DM and cardiovascular disease risk factors, showed a cardiovascular This guideline recommends that for T2DM patients significant diabetic complications with risk factors for cardiovascular blood blood pressure and to reduce and therapy are to prevent cardiovascular and diabetic The clinical in intensive glucose control trials such as The in Diabetes and and and the Diabetes Trial that intensive glucose control reduced the progression of diabetic (e.g. diabetic and 22, 24, patients who have developed diabetic clinical evidence is still to intensive glucose control measures can reduce the of and The results of clinical trials such as and that for patients with a of diabetes, who are in age and who have cardiovascular risk factors or cardiovascular the use of intensive glucose control measures does not reduce the of cardiovascular and the study showed that in the aforementioned population, intensive glucose control was with an risk of mortality This guideline recommends that for patients who are and who have a diabetes and cardiovascular the and of adopting intensive glucose control be In an should be used a diabetes management system should be developed to control is sufficient clinical evidence that in patients with T2DM who have cardiovascular blood or the use of therapy alone or in can reduce the risk of cardiovascular disease and In patients with diabetic the use of blood agents, the use of or significantly reduced the risk of diabetic progression This guideline recommends that for patients who have a diabetes and cardiovascular disease, in of control, measures such as blood to reduce and should be used to reduce the risk of cardiovascular and and to reduce the risk of diabetic The of and in diabetic patients are significantly than in and these in diabetic patients depends not only on high blood glucose also on other cardiovascular disease risk factors and In to drug diabetes control also blood glucose and other cardiovascular risk factors as to the control the or the treatment be as diabetes is a disease, the and are to diabetes diabetes control is not a treatment in the traditional a management in The ideal control of T2DM according to the age, and complications of patients (Table A treatment that does not the control should not be as a because in the control benefits to the and the with for in HbA1c are closely with in complications and The primary for the for T2DM control is which should consider age, disease of complications or and other factors of is a of diabetes. patients and those with a disease may not treatment to reduce blood pressure to mmHg or The blood pressure value for patients may be to T2DM is a The blood glucose to increase as the disease the intensity of control treatment should be intervention is the for T2DM treatment and should be applied the diabetes treatment When lifestyle alone is unable to blood glucose drug treatment should be The drug for T2DM is no are metformin should of the diabetes treatment who could not metformin may use α-glucosidase or When metformin alone is unable to blood glucose α-glucosidase inhibitors, or can be who could not metformin may undergo therapy with other oral When a therapy of types of oral still unable to blood glucose may be added or or or a of types of oral may be can be used as a treatment. When or combined with other oral is still unable to blood glucose the should be to include daily of or When with and use should be on the and the of Diabetes the American Diabetes Association and for Health and the treatment for in T2DM are proposed and shown in 1. with diabetes or prediabetes medical nutrition treatment should be the of a or an management a diabetes who is with diabetes treatment. To the metabolic control for patients and or quality should be In to control the total intake and various in a and the nutrition status should be quality For overweight or obese this guideline recommends weight loss measures combined with physical and to weight loss an important in the management of T2DM. increases control blood cardiovascular risk factors, weight and improves a primary on populations at high risk of diabetes studies have shown that the regular of more than reduced the HbA1c by and that the mortality of diabetes patients who to regular for years significantly diabetic should be to or status and the of should be and for should be and should be to patients nutrition therapy and treatment are for high blood glucose in T2DM. When diet and cannot control the blood glucose oral should be in a T2DM is a the of T2DM, less as T2DM the on control measures treatment often the use of oral and a of oral and (e.g. and is the primary currently used in medical The major of is blood glucose by the glucose and The diabetes treatment guidelines of countries and recommend metformin as the among the and for control of in T2DM of clinical trials have shown that metformin can reduce HbA1c by and can also reduce weight The efficacy of metformin shown to be from the weight The study results showed that metformin also decreased the of cardiovascular and in obese patients with T2DM In China, randomized controlled clinical trials have conducted to the of metformin and on cardiovascular in patients with T2DM combined with disease, and the results showed that metformin treatment was with a significant of major cardiovascular alone not the of metformin and or the risk of The of metformin was with a and the was an to reduce The efficacy of metformin was by weight The between and risk is are in patients with mg/dL) for mg/dL) for women or estimated rate or those major should be for patients with are and their is the by from the blood glucose trials have shown that can reduce HbA1c by At are the primary recommended in the diabetes treatment guidelines of countries and Prospective and randomized clinical studies have shown that the use of was with reduced of diabetic and the in China are and used can to in patients and in those with and may also weight with should use who can once a day. is a drug and various traditional Chinese that have a to that of with a lower risk of and a more of blood glucose primarily by the to the of the in China are and trials have shown that can HbA1c by not when used may increase the risk of when used in with or and are of TZDs, and these are more when are used in with use with increase risk of and with Association classification and disease, the of and and should not are The currently in China are and This of blood glucose by in the early and can lower HbA1c by be a and can be used or in with other The of clinical studies conducted on T2DM patients in China showed that in of was to and and was to α-glucosidase inhibitors, metformin and A of clinical studies of populations with T2DM, Chinese showed that in of than α-glucosidase and was to and For diagnosed T2DM therapy with metformin reduced HbA1c more significantly than alone with a significantly risk of of are and weight the risk and degree of are lower with than with can be used in patients with reduce blood glucose by in the are for patients who as their and In China, α-glucosidase include and of clinical studies conducted on the T2DM population, Chinese showed that α-glucosidase could reduce HbA1c by and weight loss studies of Chinese people with T2DM showed that the hypoglycaemic of a daily of of was to that of a daily of of metformin can be combined with or to α-glucosidase are such as and with a and the are to reduce The use of this alone does not to and may reduce the risk of no in and are for no increase in the incidence of occurs and this is When patients therapy with α-glucosidase glucose or can be used as and have a to levels of by the of in through of in a glucose and the in China include and trials in T2DM patients in China showed that and can reduce HbA1c by and respectively a study showed that the of was to that of and that and can reduce HbA1c by and the of is to the patient's HbA1c that is, the the HbA1c the be reduced by The use of alone does not increase the risk of have a on weight or may increase and not increase the risk of cardiovascular disease, and When or is for patients with the be reduced according to the of When in patients with or are reduce blood glucose by and in a glucose and can delay intake central in the Chinese the are and lower blood and also significantly reduce weight and improve triglycerides and blood alone not significantly increase the risk of trials of patients with T2DM, Chinese showed that the of was to that of to a weight loss of and a in blood pressure of approximately 3 mmHg reduced HbA1c by and weight by may be used alone or in with other oral A number of clinical studies have shown that when used after the of an oral or showed efficacy than the control drug of are (e.g. and which occur in the initial stage of treatment and with treatment time or can be used to intensive therapy for diagnosed T2DM For diagnosed T2DM patients with HbA1c or FPG mmol/L and with intensive therapy may be The appropriate treatment is 2 with a of mmol/L for fasting blood glucose and mmol/L for blood considering the HbA1c as treatment therapy should be combined with medical therapy and diabetes treatment include a or or or a day. For patients who to treatment after intensive the to therapy or to to should be based on the conditions as by a diabetes For patients have the therapy regular (e.g. every 3 follow-up should be blood glucose increases again FPG mmol/L or 2-h PG the should be is a of intensive therapy delivered an The appropriate populations are women with diabetes who are or to women who therapy and patients with T2DM who intensive The treatment are shown in 2. patients may which may and can be a major to the blood glucose and special of diabetic patients from diabetic which is the of in diabetes patients of diabetic is into which are also used for stage rate and stage stage early diabetic with stage clinical diabetic with and stage is an important type of for diabetic the should be the of in Study or the (Table is the most of onset among adults years. with diabetic and may have no clinical in of regular examinations are diabetic patients are recommended to undergo follow-up once every years; patients with should be once a and patients with should be once every The of should be for is according to the after The clinical standard for diabetic is shown in is one of the most complications of diabetes. may the central system more the to or in diabetic patients that cannot be to other is a diabetic The diagnosis of other diabetic relies on the screening of clinical or (1) blood glucose control, of dyslipidemia and hypertension (2) disease screening and patients should undergo screening for diabetic at least once a after the diagnosis of diabetes. For patients with a of diabetes or complications, such as and should occur every (3) patients from should receive care to reduce the incidence of (1) (2) commonly used such as and factors, may be (3) commonly used such as may be (4) commonly used include and blood for the treatment of diabetic include and and and and disease to is not a specific to diabetes, the risk of disease in patients with diabetes significantly increases with patients diabetes. In patients with diabetes also have an earlier age of onset and of lower disease, as as more and disease is a of disease that as lower or For diabetes patients over age of years, screening should be conducted For diabetes patients with risk factors (e.g. cardiovascular disease, hypertension, or a diabetes of more than years) should be at least once a For diabetes patients with and regardless of their age, a and of disease should be (1) the a regardless of the of lower a diagnosis should be (2) For a who and a by after a a diagnosis should be (3) the a or pressure mmHg or pressure a diagnosis should be The to the prevention of atherosclerotic disease the prevention of cardiovascular the prevention of and the prevention of or the of the and the of the status of patients with Therefore, the standard treatment for diabetic of primary prevention prevent or delay the occurrence of prevention and delay and prevention and reduce and cardiovascular Diabetes is an risk for cardiovascular and with diabetes have risk of cardiovascular and with patients diabetes. FPG and are with an risk of cardiovascular and when not the diagnostic criteria for diabetes. patients often important risk factors for cardiovascular and such as dyslipidemia and hypertension evidence that strict control in patients with T2DM a on the of cardiovascular and and from those among patients with a disease who are and who have a history of cardiovascular or cardiovascular risk factors However, the management of risk factors can significantly the risk of cardiovascular and and from those in patients with diabetes. Therefore, the prevention of diabetic the and control of cardiovascular disease risk factors (e.g. high blood hypertension and dyslipidemia) and appropriate At the incidence of cardiovascular risk factors is high among T2DM patients in China, and are with T2DM, only for blood and total cholesterol The use of also more screening and treatment of cardiovascular risk factors and an rate of therapy are The clinical for screening and the and for patients with T2DM are shown in 3. to an epidemiological analysis of metabolic syndrome in the current Chinese population, this guideline the of the metabolic syndrome based on the The diagnostic criteria are as follows: (1) waist ≥90 cm and women ≥85 (2) high blood fasting blood glucose mmol/L or glucose at 2 after glucose mmol/L and/or diabetes diagnosis and (3) high blood blood pressure mmHg and/or diagnosed and on (4) fasting mmol/L and (5) fasting with or more of the aforementioned are diagnosed with metabolic

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