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Japanese Clinical Practice Guideline for Diabetes 2019

2020; Asian Association for the Study of Diabetes; Volume: 11; Issue: 4 Linguagem: Inglês

10.1111/jdi.13306

2040-1124

Eiichi Araki, Atsushi Goto, Tatsuya Kondo, Mitsuhiko Noda, Hiroshi Noto, Hideki Origasa, Haruhiko Osawa, Akihiko Taguchi, Yukio Tanizawa, Kazuyuki Tobe, Narihito Yoshioka,

Diet and metabolism studies

The current guideline represents the 6th edition of the 'Japanese Clinical Practice Guideline for Diabetes' which has been revised every three years since its first appearance in 2004 to promote evidence-based, rational, efficient and consistent clinical practice in diabetes. Of note, dramatic progress has been made in recent years in diabetes research and clinical practice, which includes approval of antidiabetic agents with novel mechanisms of action along with publication of clinical trial results with these drugs, and novel diagnostic and therapeutic devices, such as continuous glucose monitoring (CGM) and sensor augmented pumps (SAP). Again, results from large-scale clinical trials in Japan, such as J-DOIT 1 to 3 and JDCP studies, have recently been reported. Further, in the last three years, new guidelines for lipid and blood pressure control have been released in a timely fashion from the Japan Atherosclerosis Society and the Japanese Society of Hypertension. Therefore, the current guideline has been compiled to include not only relevant advances in clinical practice but novel findings and new lines of evidence that have been made available to date. While the current guideline has been organized along similar lines to those of the preceding 2016 edition and using the same clinical questions (CQs) and questions (Qs) format, each CQ or Q has been closely reviewed for revision and further CQs or Qs have been added as appropriate to further promote the use of the guidelines in clinical practice. Readers are therefore referred to the 'Methods of developing the "Japanese Clinical Practice Guideline for Diabetes 2019"' for a detailed account of the guideline development processes involved to make effective use of the current guideline. It is hoped that the guideline will prove a helpful guide to evidence-based medicine (EBM) in clinical settings thereby contributing not only to prolongation of healthy lifespan but to improved quality of life in patients with diabetes. The guideline consists of general questions (cited as Qs) and clinical questions (cited as CQs) followed by explanations. Statements of recommendation were developed solely for CQs. Clinical guideline committee (CGC) members conducted systematic review (SR) of evidence from several resources to develop a statement of recommendation for CQs and presented a strength of recommendation rated as a grade. SR support team helped CGC members to make literature retrieval and confirm an evidence level for articles that they obtained. A brief criterion of the literature retrieval process was shown in this guideline. We referred to all the important articles necessary for the judgement of a statement and its strength of recommendation for CQs. Abstract tables were constructed solely for the articles necessary to recommend a statement for CQs. They contained relevant articles with PICO (Populations, Interventions, Comparators, Outcomes of interest), study design, and evidence level as defined in Table 1. The quality of evidence was also summarized based on 5 items for meta-analysis or systematic review, and 3 items for randomized controlled trial as shown in Table 1. The grade of recommendation was determined by each CGC member with consideration given to certainty of overall evidence, balance of benefits and harms, patient preferences/values, and costs (Table 2). Grades A and B stand for strong and weak recommendations, respectively. The CGC members reviewed and discussed all CQ guidelines. Votes were taken for each recommendation statement. A 75% agreement among eligible CGC members was required to approve each recommendation and its strength. Satisfies all of the following 5 items: Satisfies all of the following 3 items: I. Type 1 (Characterized by pancreatic β-cell destruction usually leading to absolute insulin deficiency) III. Diabetes due to some other specific mechanism or disease Individuals who have met the above criteria 1–3 are to be diagnosed with acute-onset (autoimmune) type 1 diabetes. Those who have met the above criteria 1, 2, and 4 are to be diagnosed with acute-onset type 1 diabetes. Those who have met the above criteria 1 and 2 but not 3 and 4 are to be re-evaluated after an interval with the diagnosis put on hold. Those who have met the criteria for fulminant type 1 diabetes are to be diagnosed as such. Some may lead to the onset of ketosis or ketoacidosis within about 1–2 weeks. The onset of fulminant type 1 diabetes may be associated with pregnancy. Exocrine pancreatic enzymes, e.g., amylase, lipase, and esterase 1, are shown to be elevated in 98% of affected individuals. Upper airway and gastrointestinal symptoms are noted in 70% of affected individuals. Fulminant type 1 diabetes is shown to be linked to HLA DRB1*04:05–DQB1*04:01. [Q2-3] How is the glycemic goal to be set for each individual patient? (Figure 5) Glucose levels in affected individuals are to be controlled as close to normal as possible. Achieving and maintaining favorable glycemic control early after initiation of treatment is likely to lead to favorable long-term outcomes in these individuals1. [Q2-4] How is the onset of chronic diabetic complications prevented or their progression delayed? Diabetes management is aimed not merely at glycemic control1 but also at ensuring continued smoking cessation and control of blood pressure and lipid levels, thereby preventing chronic diabetic complications or delaying their progression2-5. [CQ3-2] Is MNT education by registered dieticians effective? MNT education by registered dieticians is effective10, 11 (grade A: 95% agreement). As per the statement on target body weight vs total energy intake, for each patient, his/her target body weight and total energy intake is to be individually determined. Again, all values given below are primarily intended as suggested targets only and therefore need to be modified, as required, during patient consultation, in consideration of each patient's current body weight, glycemic control and other parameters. There is also a need for accumulating evidence for body weight and total energy intake determination. For elderly patients, the coefficient could be made larger than that associated with their actual level of physical activity to prevent them from developing frailty. Conversely, for obese patients in a weight loss program, the coefficient could be made lower than that associated with their actual level of physical activity. In either case, individuals whose actual body weight widely differs from their target body weight, the coefficient could be flexibly determined with consideration given to the levels of physical activity and corresponding energy coefficients to given above. Given that insulin is shown to have a wide-ranging action affecting not only glucose metabolism but lipid and protein metabolism, all of which are closely linked, energy-producing nutrients as components of MNT must be assessed for their balance and validity against each patient's disease condition, as well as associated risks including hyperglycemia. Furthermore, consideration is to be given not only to the safety of the dietary components but to Japanese cuisine culture and patient preferences, to ensure long-term implementation of MNT. However, there is no evidence available to support the effectiveness of any particular dietary nutrient ratios that contribute to long-term management of diabetes. To ensure long-term implementation of MNT in patients with diabetes, priority is to be given to honoring their eating habits and preferences thus allowing them to enjoy their meals as far as they do not defeat the purpose of MNT medically, while at the same time giving consideration to any potential risks associated with their individual diet regimens. Advantage: This Scr-based formula offers convenience by allowing renal function to be estimated with a blood test alone. With this formula, eGFR is likely to fall ± 30% of measured GFR (mGFR) in 75% of patients. Disadvantage: Adjusted for average body surface area (BSA) (1.73 m2), the formula is likely to be associated with a greater estimation error in patients of large and small build. The formula is also associated with overestimated values in patients with low muscle mass. Advantage: Secreted from all nucleated cells, cysteine C is thought less likely to be influenced by muscle mass or dietary content. Disadvantage: Adjusted for average BSA (1.73 m2), the formula is also likely to be associated with a greater estimation error in patients of large and small build. Subjective symptoms of diabetic polyneuropathy are characterized as: Findings of interest (diabetic neuropathy is to be confirmed if one of the following two has been met, despite failure to meet the criteria described above) [Q15-3] What is the office blood pressure threshold for initiating antihypertensive therapy in patients with diabetes? (Table 7, Figure 6) [CQ15-4] Is controlling office blood pressure to <130/80 mmHg effective in preventing the onset of complications in patients with diabetes and hypertension? (Figure 7) GDM is diagnosed if one or more of the following criteria have been met in a 75 g OGTT: ① Fasting blood glucose value ≥92 mg/dL ② 1-h post-OGTT glucose value ≥180 mg/dL ③ 2-h post-OGTT glucose value ≥153 mg/dL Overt diabetes in pregnancy is diagnosed if ① or ② below has been met: ① Fasting blood glucose value ≥126 mg/dL ② HbA1c ≥6.5% ① Diabetes mellitus diagnosed before pregnancy ② Pregnancy associated with unequivocal evidence of diabetic retinopathy <5.3 mmol/L*4 (<95 mg/dL) 1-h PPG <140 mg/dL Or 2-h PPG <120 mg/dL 1-h PPG <140 mg/dL Or 2-h PPG <120 mg/dL 1-h PPG <7.8 mmol/L (<140 mg/dL) Or 2-h PPG 80% of all pancreas transplants performed in Japan and the rest of the world. Data from the 361 brain-dead and non-heart beating donor pancreas transplants, performed in Japan as of the end of 2014, demonstrated a 5-year graft survival rate of 94.9%, with the 5-year pancreas and kidney survival rates of 76.0% and 91.4%, respectively. Islet transplantation is a form of tissue transplantation that involves transplanting islets isolated from a donor pancreas into the portal vein of a recipient. Islet transplantation is performed on insulin-depleted patients with diabetes shown to have severe hypoglycemia repeatedly despite receiving specialist diabetes care. While, unlike pancreas transplantation, islet transplantation may not allow its recipients to remain off insulin therapy for prolonged periods of time, it is expected to reduce the frequency of hypoglycemia and mean glucose values by stabilizing glycemic variations. Islets transplantation from non-heart-beating donors were conducted 34 times to a total of 18 patients (male/female, 5/13) with the modified Edmonton protocol between 2004 and 2007 in Japan1. As in Western studies, HbA1c was improved, and severe hypoglycemia resolved, among those with successful islet engraftment1. While the need for multiple transplants and improvement of long-term prognosis were among the challenges with islet transplantation, the University of Minnesota protocol, which consists of induction immunotherapy with antithymocyte globulin (thymoglobulin) or an anti-TNF-α receptor antibody followed by maintenance therapy with a low-dose calcineurin inhibitor (tacrolimus) and an mTOR inhibitor (sirolimus) or an anti-metabolic agent (mycofenolate mofetil), was reported to lead to the secession from insulin therapy in all 8 patients with type 1 diabetes receiving islet transplants from each single donor2. In Japan, from 2012 onwards, islet transplantation was resumed as a part of advanced medical care B program in insulin-depleted patients presenting with severe hypoglycemic episodes, employing a similar protocol to that of University of Minnesota and is currently being implemented as First-class Regenerative Medicine according to the 'Act on Securing Safety of Regenerative Medicine'. Between March 2007 and March 2012, the Japan Diabetes Outcome Intervention Trial 1 (J-DOIT1) was conducted to investigate the effectiveness of non-face-to-face, telephone-based intervention in individuals at high risk of diabetes in preventing incident diabetes. Of the people undergoing health check-ups in the fiscal year 2006, high-risk individuals (i.e., those with impaired fasting glucose [IFG]) aged 20–65 years were identified and allocated to the intervention group (n = 1,367) and the self-management group (n = 1,240). After completion of one-year intervention, the study followed up all subjects for 5.5 years on average by way of annual health check-ups and questionnaires and found no significant difference in cumulative incidence of diabetes between the intervention and self-management groups but did find a significantly lower incidence (−41%) among those receiving telephone counselling 10 times per year than among those receiving such counselling 3 or 6 times per year in the intervention group when analyzed at each study site. The 'Japan Diabetes Outcome Intervention Trial 2 (J-DOIT 2)' was an interventional study intended to address how to decrease consultation interruptions by patients with type 2 diabetes. The interventional measures implemented in the study included encouraging patients who were being treated by their family physicians to continue treatment/consultation, providing healthcare instructions, and assisting their family physicians in their treatment/consultations. The results of the study demonstrated that treatment/consultation interruptions decreased by 63%, suggesting that the interventional measures were significantly effective. In J-DOIT3, a total of 2,542 patients with type 2 diabetes and hypertension/dyslipidemia aged 45 to 69 years were randomly assigned to receive current guideline-consistent treatment (conventional therapy group; targets, HbA1c <6.9%, blood pressure 130/80 mmHg, LDL-cholesterol <120 mg/dL [or <100 mg/dL in those with a history of cardiovascular disease]) or to receive treatment aimed at more stringent control (intensive therapy group; targets, HbA1c <6.2%, blood pressure 120/75 mmHg, LDL-cholesterol <80 mg/dL [or <70 mg/dL in those with a history of cardiovascular disease]). At median follow-up of 8.5 years, the primary endpoints of the study (i.e., all-cause mortality, myocardial infarction, stroke, coronary/cerebral artery revascularization) were reduced by 19% in the intensive therapy group, while this reduction was not significantly different from that in the conventional therapy group (P = 0.094) but were significantly reduced by 24% after adjustment for all pre-specified factors, such as smoking (P = 0.042), compared to that in the conventional therapy group1. The JDCP study was a large-scale prospective observational study of Japanese patients with type 1 and type 2 diabetes. The study was conducted to identify the risk factors for diabetes-related comorbidities that they develop during follow-up. The JDCP study enrolled a total of 6,338 patients, 40–74 years of age who were being treated at participating sites nationwide between June 2007 and November 2009. The primary endpoints of the study included the onset/progression of nephropathy, retinopathy, neuropathy, macroangiopathy, and periodontal disease. All events observed in the course of the study are currently being reviewed by the 8 subspecialty working groups involved in the study. A large-scale registry needs to be built in an attempt to clarify how patients with diabetes are being currently treated and how diabetic complications may occur as a result, as well as to provide recommendations toward improved diabetes care and healthcare policy. Thus, with these objectives in mind, a large-scale registry has been built since 2015 as a joint project between the Japan Diabetes Society (JDS) and the National Center for Global Health and Medicine, solicitating the participation of JDS-accredited diabetes education facilities. At the end of 2018, a total of 51 university and other facilities have participated in the project, with the number of patients registered totaling some 54,000, of whom 1,900 or more patients have type 1 diabetes. 1 GUIDELINE FOR THE DIAGNOSIS OF DIABETES MELLITUS