Japanese Clinical Practice Guideline for Diabetes 2019

Abstract

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 favo