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SummaryConcept of diabetes mellitusDiabetes mellitus is a group of diseases associated with various metabolic disorders, the main feature of which is chronic hyperglycemia due to insufficient insulin action. If any of the criteria for diabetic type (i) through to (iv) is observed at the initial examination, the patient is judged to be a€?diabetic type.a€? Re-examination is conducted on another day, and if a€?diabetic typea€? is reconfirmed, diabetes mellitus is diagnosed.
If the plasma glucose level indicates diabetic type [any of (i), (ii), or (iii)] and either of the following conditions exists, diabetes mellitus can be diagnosed immediately at the initial examination.
The presence of typical symptoms of diabetes mellitus (thirst, polydipsia, polyuria, weight loss).
If it can be confirmed that the above conditionsA 1 or 2 existed in the past, diabetes mellitus can be diagnosed or suspected regardless of the current test results. If the diagnosis of diabetes cannot be established by these procedures, the patient is followed up and re-examined after an appropriate interval. The physician should assess not only the presence or absence of diabetes, but also its etiology and glycemic stage, and the presence and absence of diabetic complications or associated conditions. Epidemiological studyFor the purpose of estimating the frequency of diabetes mellitus, a€?diabetes mellitusa€? can be substituted for the determination of a€?diabetic typea€? from a single examination. However, diabetes mellitus that is diagnosed by the clinical diagnosis of diabetes mellitus defined earlier is excluded from GDM. Review of the history of diagnostic criteria for diabetes mellitus by the Japan Diabetes Society and international backgroundThe Japan Diabetes Society (JDS) has published reports on the diagnostic criteria for diabetes mellitus three times [2a€“4].
Concept of diabetes mellitusDiabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia due to insufficient insulin action. ClassificationEtiological classification and pathophysiological stagesEtiology and pathophysiological stages (or states) should be assessed separately for each patient. A scheme of the relationship between etiology (mechanism) and patho-physiological stages (states) of diabetes mellitus. The occurrence of diabetes-specific complications has not been confirmed in some of these conditions. Type 1 diabetes mellitusDiabetes mellitus is caused by insulin deficiency due to destruction of pancreatic I?-cells principally via an autoimmune reaction, which is itself triggered by different factors.
Diabetes mellitus with identified genetic abnormalities: With the recent progress in genetic technology, several single genetic abnormalities have now been identified as causing diabetes mellitus [24a€“29]. Various types of diabetes associated with other disorders and conditions: Some disorders, syndromes and conditions can be accompanied by a diabetic stage, and these have conventionally been called secondary diabetes. Gestational diabetes mellitusGlucose metabolism disorder that is first discovered or develops during pregnancy, excluding clinically diagnosed diabetes mellitus (details described later). Physical characteristics, such as obesity, history of weight changes in the past, hearing disturbance (mitochondrial DNA abnormality) and acanthosis nigricans (severe insulin resistance). For diagnosing type 1 diabetes mellitus, examination of islet-associated antibodies such as GAD antibody, IA-2 antibody, insulin autoantibody (IAA; present before the use of insulin), islet cell antibody (ICA) and ZnT8 antibody. Tests for insulin secretion and insulin resistance (fasting plasma insulin and C-peptide levels, insulin response to glucose loading, and, in particular cases, hyperinsulinemic euglycemic clamp or minimal model etc.). DNA analysis may give a definite diagnosis in special cases belonging to A(1) and A(2) in TableA 2. However, the etiological classification of diabetes mellitus based on these data is not immediately required for treatment.To assess the pathophysiological stage of diabetes, clinical information (history of the disease, glycemic level and its stability, ketosis-proneness, and response to diet and drug therapy), plasma insulin assays (fasting and after glucose load, and after intravenous glucagon), and C-peptide assays in plasma and urine will help to evaluate the degree of insulin deficiency. DiagnosisThe diagnosis of diabetes mellitus is the process of confirming that the subject conforms to the disease concept described earlier.
The plasma glucose is often elevated temporarily in cases of severe stress (for example, infections, myocardial infarction, stroke and surgery). If the plasma glucose level indicates diabetic type [any of (i)a€“(iii)] and either of the following conditions exists, diabetes mellitus can be diagnosed, even at the initial examination. A a€? If HbA1c is used at initial examination, another method of determination is required for diagnosis at re-examination. For the purpose of estimating the frequency of diabetes mellitus, determination of "diabetic type" from a single test can be considered to represent "diabetes mellitus". It is important to detect diabetes mellitus and identify high risk groups without overlooking anyone.
If it can be confirmed that either of the conditionsA 1 or 2 existed in the past, diabetes mellitus must be diagnosed or suspected, even if the present test values do not meet these conditions. If diabetes mellitus is suspected, but the diagnosis cannot be made by conditions 1a€“3, diabetes mellitus should be suspected, and plasma glucose level and HbA1c should be measured again within 3a€“6A months. Points to keep in mind are that when fasting plasma glucose level is used for determination, it is important to confirm the fasting conditions. OGTT evaluates the rate of glucose disposal after an oral glucose challenge, and is the most sensitive test to detect a mild disturbance of glucose metabolism. Normal type: Normal type is defined as a range of glycemia that is unlikely to develop into diabetes after several years of observation.
Borderline type: This category is defined when the pattern of OGTT is neither diabetic nor normal type.
All recommendations have been updated and reorganized to clarify management considerations for women with pregestational or gestational diabetes in the prepregnancy period, during pregnancy, and in the intrapartum and postpartum periods. 1.All women of reproductive age with type 1 or type 2 diabetes should receive advice on reliable birth control, the importance of glycemic control prior to pregnancy, the impact of BMI on pregnancy outcomes, the need for folic acid and the need to stop potentially embryopathic drugs prior to pregnancy [Grade D, Level 4 (1)]. 4.Women with type 2 diabetes who are planning a pregnancy should switch from noninsulin antihyperglycemic agents to insulin for glycemic control [Grade D, Consensus]. 6.Women should be screened for chronic kidney disease prior to pregnancy (see Chronic Kidney Disease chapter, p. 9.Detemir [Grade C, Level 2 (24)] or glargine [Grade C, Level 3 (25)] may be used in women with pregestational diabetes as an alternative to NPH.
11.Women should receive adequate glucose during labour in order to meet their high-energy requirements [Grade D, Consensus]. 12.Women with pregestational diabetes should be carefully monitored postpartum as they have a high risk of hypoglycemia [Grade D, Consensus].
15.All women should be encouraged to breastfeed since this may reduce offspring obesity, especially in the setting of maternal obesity [Grade C, Level 3 (28)]. 17.If there is a high risk of GDM based on multiple clinical factors, screening should be offered at any stage in the pregnancy [Grade D, Consensus].
21.Receive nutrition counselling from a registered dietitian during pregnancy [Grade C, Level 3 (37)] and postpartum [Grade D, Consensus]. 22.If women with GDM do not achieve glycemic targets within 2 weeks from nutritional therapy alone, insulin therapy should be initiated [Grade D, Consensus].
23.Insulin therapy in the form of multiple injections should be used [Grade A, Level 1 (20)].
24.Rapid-acting bolus analogue insulin may be used over regular insulin for postprandial glucose control, although perinatal outcomes are similar [Grade B, Level 2 (38,39)]. 27.Women should receive adequate glucose during labour in order to meet their high-energy requirements [Grade D, Consensus]. 29.Women should be screened with a 75 g OGTT between 6 weeks and 6 months postpartum to detect prediabetes and diabetes [Grade D, Consensus].
We examined the restoration of first-phase and total insulin response as well as hepatic and peripheral insulin sensitivity. In 2009, a minor revision was made regarding the normal range of fasting plasma glucose level [5].In 1970, the JDSa€™s first committee proposed reference values for plasma glucose determination in the oral glucose tolerance tests (OGTT) [2]. The common feature of this group of diseases is a deficiency of insulin action, which leads to abnormalities in almost the entire metabolic system, including carbohydrate, lipid and protein metabolism.
Before development of overt diabetes, patients will pass stages at which different degrees of deficiency of insulin action exist.
Arrows pointing right represent worsening of glucose metabolism disorders (including onset of diabetes mellitus). The terms insulin-dependent and non-insulin-dependent are used for pathophysiological staging of diabetes mellitus regardless of the etiology.
These are divided into (i) genetic abnormalities related to pancreatic I?-cell function; and (ii) genetic abnormalities relevant to mechanisms of insulin action. They include diabetes associated with pancreatic disease, endocrine disease, liver disease, drug use, exposure to chemical substances, viral infections, and various genetic syndromes.
The etiology is presumably based on common pathogenic mechanisms with type 1 and type 2, with pregnancy triggering the manifestation of a glucose metabolism disorder. Re-examination is conducted at another date, and diabetes mellitus is diagnosed if a€?diabetic typea€? is reconfirmed.
When the results of the fasting plasma glucose level, casual plasma glucose level or HbA1c measurement are not definite, OGTT results provide solid information for diagnosing diabetes mellitus.
In clinical cases, it is recommended also to measure plasma glucose at 30 and 60A min to enhance the accuracy of diagnosis. As in past JDS committee reports, the results are classified as normal, borderline and diabetic types [2a€“4].
Borderline type includes heterogeneous conditions: a subject in transition to developing diabetes, diabetes in remission, insulin resistance syndrome and temporary deterioration of glucose tolerance due to stress in an essentially healthy individual.
Women with pregestational diabetes who also have PCOS may continue metformin for ovulation induction [Grade D, Consensus]. S129) [Grade D, Level 4, for type 1 diabetes (17) ; Grade D, Consensus, for type 2 diabetes]. If the initial screening is performed before 24 weeks of gestation and is negative, rescreen between 24 and 28 weeks of gestation.
Recommendations for weight gain during pregnancy should be based on pregravid BMI [Grade D, Consensus]. Use of oral agents in pregnancy is off-label and should be discussed with the patient [Grade D, Consensus]. Effectiveness of a regional prepregnancy care program in women with type 1 and type 2 diabetes: benefits beyond glycemic control. Preconception care for diabetic women for improving maternal and fetal outcomes: a systematic review and meta-analysis.


Preconception care and the risk of congenital anomalies in the offspring of women with diabetes mellitus: a meta-analysis.
Poor glycated hemoglobin control and adverse pregnancy outcomes in type 1 and type 2 diabetes mellitus: systematic review of observational studies. Glycemic control during early pregnancy and fetal malformations in women with type 1 diabetes mellitus. Use of maternal GHb concentration to estimate the risk of congenital anomalies in the offspring of women with pre-pregnancy diabetes. Glycaemic control is associated with preeclampsia but not with pregnancy-induced hypertension in women with type 1 diabetes mellitus. Strategies for reducing the frequency of preeclampsia in pregnancies with insulin-dependent diabetes mellitus. Effect of pregnancy on microvascular complications in the Diabetes Control and Complications Trial. Maternal exposure to angiotensin converting enzyme inhibitors in the first trimester and risk of malformations in offspring: a retrospective cohort study. Central nervous system and limb anomalies in case reports of first-trimester statin exposure.
Microalbuminuria, preeclampsia, and preterm delivery in pregnancy women with type 1 diabetes: results from a nationwide Danish study. Improved pregnancy outcome in type 1 diabetic women with microalbuminuria or diabetic nephropathy: effect of intensified antihypertensive therapy? Twice daily versus four times daily insulin dose regimens for diabetes in pregnancy: randomised controlled trial.
Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women.
Glycemic control and perinatal outcomes of pregnancies complicated by type 1 diabetes: influence of continuous subcutaneous insulin and lispro insulin.
A comparison of lispro and regular insulin for the management of type 1 and type 2 diabetes in pregnancy. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. Breast-feeding and risk for childhood obesity: does maternal diabetes or obesity status matter?
Fasting plasma glucose versus glucose challenge test: screening for gestational diabetes and cost effectiveness. Impact of increasing carbohydrate intolerance on maternal-fetal outcomes in 3637 women without gestational diabetes.
Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy.
Recommendations for nutrition best practice in the management of gestational diabetes mellitus. Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus.
Prospective observational study to establish predictors of glyburide success in women with gestational diabetes mellitus. Comparative placental transport of oral hypoglycemic agents in humans: a model of human placental drug transfer. Comparison of glyburide and insulin for the management of gestational diabetes in a large managed care organization. Effects of early breastfeeding on neonatal glucose levels of term infants born to women with gestational diabetes.
Association of breast-feeding and early childhood overweight in children from mothers with gestational diabetes mellitus.
Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort.
Additionally, to examine the mechanistic basis of observed outcomes, we quantified the change in fat content of the pancreas and liver The data are consistent with the hypothesis that the abnormalities of insulin secretion and insulin resistance that underlie type 2 diabetes have a single, common aetiology, i.e.
The long-term persistence of metabolic disorders can cause susceptibility to specific complications and also foster arteriosclerosis.
Moreover, if the plasma glucose values [any of criteria (i), (ii), or (iii)] and the HbA1c [criterion (iv)] in the same blood sample both indicate diabetic type, diabetes mellitus is diagnosed based on the initial examination alone.
GDM is diagnosed if one or more of the following criteria is met in a 75A g OGTT during pregnancy: 1. At that time, glucose tolerance was assessed using the OGTT, and the JDS took the position that the diagnosis of diabetes mellitus should be carried out comprehensively, and should include an evaluation of glucose tolerance. The mechanism for a lack of insulin action in this group of diseases includes insufficient insulin secretion (absolute or relative) and decreased insulin sensitivity (insulin resistance) in organs (cells) on which insulin acts.The causes of diabetes mellitus are various, including both genetic and environmental factors. The abnormal glucose metabolism not only progresses, but may regress spontaneously or in response to treatment.
In this case, failure to administer insulin in an insulin-dependent condition can lead to ketosis and can be life threatening.
It is debated whether gestational diabetes mellitus (GDM) should be treated as an independent etiological classification, but due to its clinical importance, the need for special consideration and different features from diabetes in the absence of pregnancy, it is treated as a separate category. Plasma glucose level after glucose load in oral glucose tolerance test (OGTT) is not included in casual plasma glucose levels. In the present report, plasma glucose and HbA1c levels are described as a€?type,a€? as in past reports of the JDS. Re-examination is carried out at another date, and diabetes mellitus is diagnosed if a€?diabetic typea€? is confirmed againb.
In clinical practice, OGTT is recommended for confirming glucose tolerance in cases as shown in TableA 6, except when overt symptoms of diabetes, marked hyperglycemia or ketosis are present. The measurement of plasma insulin can help to predict the risk for future development of diabetes. The normal range and the diabetic range of fasting plasma glucose levels and OGTT 2-h values are shown in TableA 3. In a previous JDS report, normal type was considered as a€?patients mostly do not develop diabetes mellitus even after several years of follow up,a€? and the plasma glucose criteria were thus set at lower levels [2, 3].
Subjects with borderline type are at little risk of developing diabetes-specific microangiopathy, but at increased risk of progressing to diabetes and to developing macroangiopathy. Women with microalbuminuria or overt nephropathy are at increased risk for development of hypertension and preeclampsia [Grade A, Level 1 (17,18)] and should be followed closely for these conditions [Grade D, Consensus].
If HbA1c is used, it is essential that the plasma glucose level [criteria (i), (ii), or (iii)] also indicates diabetic type for a diagnosis of diabetes mellitus.
Insufficient insulin secretion can occur in association with destruction of pancreatic islet I?-cells or due to dysfunction within the pancreatic I?-cells themselves.
For example, islet autoantibodies are occasionally detected before recognition of hyperglycemia, suggesting that the autoimmune process of type 1 diabetes has already begun. Patients whose conditions do not require insulin treatment for prevention of ketosis or for survival, but require insulin for glycemic control are considered to be in a non-insulin-dependent state.Etiological classificationEtiological classifications of diabetes mellitus and glucose metabolism disorders are shown in TableA 1, and use the terms type 1 and type 2. As destruction of pancreatic I?-cells progresses, an absolute deficiency in insulin often occurs. This is because pregnancy itself worsens glucose metabolism, and diagnosis and control require special considerations that are different from those in the absence of pregnancy, and even a comparatively mild disorder in glucose metabolism during pregnancy can exert significant influence on the infant and mother. Fasting plasma glucose is measured before breakfast under fasting conditions, at least 10A h from the night before (water may be consumed). If the same blood sample is confirmed to be a diabetic type both by the plasma glucose level and HbA1c [any of (i)a€“(iii) plus (iv)], then diabetes mellitus can be diagnosed from the initial examination. In case of the disorders and conditions shown in TableA 5, in which HbA1c may be apparently low, the plasma glucose level should be used for diagnosis. The solution should be consumed within 5A min, and evaluation should be timed from the time that the patient starts to drink.
However, in the 1999 JDS report, the upper limit of normal type was set at the same value as the lower limit of the WHO IGT reference value. This provides a unified hypothesis to explain a common disease that previously appeared to require separate disease processes affecting the pancreas and insulin-sensitive tissues.
When diabetes mellitus is suspected, HbA1c should be measured at the same time as examination for plasma glucose. Besides the decrease in insulin supply, decreased insulin sensitivity can contribute to relative insufficient insulin action.
Obese diabetic patients may be improved to borderline type or even to normal glucose tolerance after weight reduction with diet therapy. In recent years, various forms of diabetes with genetic abnormalities have been identified, and are treated as a separate category.
It is typically regarded as developing rapidly in young people, but it can occur in any age group.In many cases, autoantibodies against islet antigens (islet-associated antibodies) are verifiable in the early phase of the disease, and because pancreatic I?-cell destruction involves autoimmune mechanisms, these are called a€?autoimmunea€? type 1 diabetes mellitus.
When HbA1c is used, it is essential that the plasma glucose level [any of (i)a€“(iii)] also indicates diabetic type for a diagnosis of diabetes mellitus. OGTT is an important diagnostic tool allowing physicians to avoid the risk of overlooking these patients [5, 33, 34]. This position is still maintained today.In 1979, the American National Diabetes Data Group published diagnostic criteria based on the 75A g OGTT and classifications such as insulin-dependent diabetes mellitus and non-insulin-dependent diabetes mellitus [6].
In either case, the principal mechanism for development of diabetes is decreased functional pancreatic I?-cell mass that results in failure to provide adequate insulin action on the organs.
The horizontal axis in FigureA 1 shows the degree of deficiency of insulin action associated with a disorder of glucose metabolism.
An individual patient may have diabetes mellitus resulting from multiple etiological causes.


There are also cases that reach an insulin-dependent state without verifiable autoantibodies, and these are called a€?idiopathica€? type 1 diabetes mellitus.
Mitochondrial genetic abnormalities [26] and amylin genetic abnormalities [27] are also included in (i). In particular, OGTT is strongly recommended in the case of (i) and should be carried out if possible in case of (ii). Nothing, except for water, can be consumed until the test is completed, and the patient should remain as quiet as possible and may not smoke during the test. Prior to the onset of spontaneous diabetes in rodents, both total pancreatic fat and islet triacylglycerol content increase sharply. Type 2 diabetes is characterized by combinations of decreased insulin secretion and decreased insulin sensitivity (insulin resistance).
At that time, mild glucose intolerance was categorized as impaired glucose tolerance (IGT). The associated metabolic disorders can be improved by various therapeutic means to ameliorate insufficient insulin action.If the metabolic abnormality is mild, patients may be asymptomatic, and thus may neglect it for a long time. The patients are judged to have diabetes when hyperglycemia has exceeded a certain level, which is presumed to confer risk for specific complications.
However, patients who are dependent on insulin therapy and are autoantibody negative, but due to an identified cause, such as a genetic abnormality, and those with temporary insulin dependence, such as soft drink ketosis, are not included in the idiopathic category.
Recently, in neonatal diabetes, genetic abnormalities in Kir6.2 and SUR1, which form the KATP channel in pancreatic I?-cells, have been identified [31, 32].
Measuring urinary glucose at the same time is useful to estimate the urinary glucose excretion threshold. In vitro, chronic saturated fatty acid exposure of beta cells inhibits the acute insulin response to glucose, and removal of fatty acids allows recovery of this response. Glucose metabolism disorders in category (iii) are divided into two subgroups; subgroup A is diabetes in which a genetic abnormality has been identified, and subgroup B is diabetes associated with other pathologic disorders or clinical conditions. In 1980, the World Health Organization (WHO) Expert Committee issued a report based on this definition [7].
However, in a metabolic state with markedly high plasma glucose levels, thirst, polydipsia, polyuria and weight loss can be seen.
Depending on the manner of onset and progression, it is classified as fulminant, acute or slowly progressive [16a€“20].Type 2 diabetes mellitusDiabetes mellitus develops in association with multiple genetic factors that lead to decreased insulin secretion or insulin resistance augmented by lifestyle habits, such as overeating (especially high fat diet), lack of exercise and resultant obesity, as environmental factors and results in insufficient insulin action. For a diagnosis of diabetes mellitus, at least fasting and 2-h plasma glucose levels are measured. The present data provide clear evidence that decreasing total pancreatic fat is associated with a return of beta cell function.
The staging of glucose metabolism includes normal, borderline and diabetic stages depending on the degree of hyperglycemia occurring as a result of the lack of insulin action or clinical condition.
In light of this, the JDS established a second committee and published criteria using the 75A g OGTT [3].
In the most extreme cases, ketoacidosis or a marked hyperosmotic, hyperglycemic state occurs, which can lead to disturbance of consciousness, coma and even death if no effective treatment is provided.With long duration of diabetic metabolism, diabetes-specific complications, chiefly involving small vessels (retinopathy, nephropathy and neuropathy), may ensue and lead to serious outcomes, such as visual disturbance, renal failure and gangrene. It is presumed that most cases involve multiple genetic factors, with some of these now elucidated [21, 22].
However, it is probable that the negative effect on beta cell function is exerted by toxic intermediaries such as diacylglycerol and ceramides, which change rapidly in response to acute metabolic changes, rather than by stored triacylglycerol per se, which acts as an index of fatty acid intermediary concentration.
The diabetic stage is then subdivided into three substages: non-insulin-requiring, insulin-requiring for glycemic control, and insulin-dependent for survival.
Diabetes accelerates and exacerbates the occurrence of arteriosclerosis, increasing the risks for myocardial infarction, stroke and occlusive artery disease of the lower extremities. Decreased insulin secretion and decreased insulin sensitivity are both involved in the onset of type 2 diabetes mellitus, but the proportion of their involvement differs according to the patient. In patients who have undergone a gastrectomy, the plasma glucose level may rise dramatically soon after the glucose load. The two former conditions are called non-insulin-dependent diabetes and the latter is known as insulin-dependent diabetes. The report at that time also recommended making a diagnosis using the fasting plasma glucose level without OGTT in routine clinical practice. These complications constitute the major causes of morbidity and mortality in diabetic patients. Endless access to abundant calories from carbohydrate may be an evolutionarily novel, and thus pathology-inducing, situation.
Because IGT, which is defined by the 2-h plasma glucose level, cannot be determined without conducting an OGTT, a fasting plasma glucose level between normal and diabetes mellitus values was defined as impaired fasting glucose (IFG) instead.
Pancreatic I?-cell function is retained to a certain degree, and insulin injections are rarely required for survival. The WHO expert committee issued a similar proposal in 1999, although continuing to recognize the necessity of OGTT in clinical practice [9].Meanwhile, the JDS had established a third committee on diagnosis and classification in 1995, and had begun updating opinions from an academic panel. They considered the new reports from the ADA and the WHO, and a report on classification and diagnostic criteria for diabetes mellitus was issued in 1999, which has been used until this revision [4]. Insulin secretion is particularly decreased in the early secretory response after a glucose load.
Borderline type (neither diabetic nor normal type) is defined as falling between the diabetic and normal values. Etiological classification was emphasized, and diabetes mellitus was divided into type 1, type 2, other types, and gestational diabetes mellitus, together with classification according to pathophysiological stage. Obesity or a history of obesity is common.Onset is commonly regarded to be in middle age or later, but this type of diabetes mellitus has recently been shown to be increasing in children and young people [23]. According to the current revision, in addition to the earlier listed plasma glucose values, hemoglobin A1c (HbA1c) has been given a more prominent position as one of the diagnostic criteria. Clinical diagnosis of diabetes mellitus requires observation of a diabetic type at least twice in tests on different days. Although borderline cases show few of the specific complications of diabetes mellitus, the risk of arteriosclerosis is higher than those of normal type. And yet everything happens only a certain number of times, and a very small number really Leave a Reply Cancel reply You must be logged in to post a comment. The principal reason for this reduction was that IGT was often overlooked in conventional testing based on fasting plasma glucose level alone.
In 2008, this segment was called a€?high-normala€™ within the range of normal fasting plasma glucose [5].Furthermore, the JDS newly established a committee for diagnostic criteria that reviewed the current diagnostic criteria and examined the practical use of HbA1c. The standardization of HbA1c measurement in Japan was examined in the early stage [12], and in the 1999 committee report on the classification and diagnostic criteria for diabetes mellitus, the JDS took global initiative by including HbA1c as an additional tool for diabetes mellitus diagnosis [4]. The main reason for this is that HbA1c measurement had not been sufficiently standardized [8]. Thereafter, the standardization of HbA1c measurement was investigated by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and an international expert committee formed by members of the ADA, the European Diabetes Association, and the International Diabetes Federation recommended the use of the HbA1c values of the National Glycohemoglobin Standardization Program (NGSP) for the diagnosis of diabetes mellitus in June 2009 [13]. HbA1c has several advantages in that it is a suitable index of chronic hyperglycemia, a characteristic of diabetes mellitus, blood samples can be taken without concern about the effects of meals, it shows less day-to-day changes than the plasma glucose level, and its relation to the risk of retinopathy is equivalent to that of the plasma glucose level.
Although HbA1c is widely used as an index for treatment or for epidemiological data, this test alone has not generally been used to diagnose diabetes mellitus.
The ADA's expert committee therefore examined the validity of using HbA1c for diagnosis, and in a 1997 report recommended against the use of HbA1c for diagnosing diabetes mellitus. This position was taken mainly because of the lack of progress in standardizing the test [8]. In an additional 2003 report, although HbA1c standardization became possible by applying NGSP, it was still considered that there were disadvantages when using it for diagnosis [10]. However, according to a 2009 report, evaluation of HbA1c as a diagnostic tool was improved, as the accuracy and precision of HbA1c measurement were shown to be similar to those of plasma glucose levels [13].
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