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Cited by 545Diabetes Treatment and ManagementClinical practice guidelines implementationDiabetes Management and Research

The DOI matches its Crossref record; 451 of the 451 references it cites were found in a registry or an index; 5 of the 281 sources its claims cite were checked for support.

Japanese Clinical Practice Guideline for Diabetes 2019

Open access
Araki, Eiichi, Goto, Atsushi, Kondo, Tatsuya, Noda, Mitsuhiko, Noto, Hiroshi, Origasa, Hideki, Osawa, Haruhiko, Taguchi, Akihiko, Tanizawa, Yukio, Tobe, Kazuyuki, Yoshioka, Narihito·2020·Diabetology International
DOI 10.1007/s13340-020-00439-5PMC PMC7378414
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Overview

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TL;DR

This is the 6th edition of the Japanese Clinical Practice Guideline for Diabetes 2019, developed by the Japan Diabetes Society to promote evidence-based, rational, efficient and consistent diabetes care. It presents graded recommendations (Grade A/B) across diagnosis, management, complications, and special populations using a clinical question (CQ)/question (Q) format.

Key findings

  • Diagnosis is confirmed by two assessments of diabetic type (one blood glucose mandatory), one assessment plus typical hyperglycemia symptoms, or evidence of prior diagnosis; fasting glucose 100–109 mg/dL is classified as "high normal" within the normal type.
  • Glycemic target is generally HbA1c <7.0% (corresponding to fasting glucose <130 mg/dL and 2-h postprandial <180 mg/dL), set individually by age, duration, organ damage, hypoglycemia risk, and support.
  • Numerous Grade A recommendations with stated agreement: MNT effective (100%), MNT education by registered dieticians (95%), physical activity/exercise (100%), organized self-management education (100%), intensive insulin therapy for microangiopathy in type 1 (100%) and type 2 (94%) diabetes, routine ophthalmologic check-up (95%), glycemic control for nephropathy (100%), and glycemic control for neuropathy (90%).
  • For elderly patients, appropriate glycemic control focused on safety rather than tight control is recommended (Grade A), with a J-curve noted between HbA1c and macroangiopathy/mortality.

Methods

  • Guideline development used general questions (Qs) and clinical questions (CQs); recommendation statements were developed solely for CQs.
  • Clinical Guideline Committee members conducted systematic reviews, with a support team assisting literature retrieval and evidence-level confirmation; abstract tables used PICO, study design, and evidence level (1+ highest to 3 lowest).
  • Grades were determined considering certainty of overall evidence, balance of benefits and harms, patient preferences/values, and costs; Grade A = strongly recommended, Grade B = weakly recommended; a 75% agreement among eligible committee members was required to approve each recommendation.

Limitations

  • The paper states a paucity of evidence in several areas, including routine foot examinations for preventing diabetic foot, protein restriction for diabetic nephropathy, behavioral therapy for glycemic control in type 2 diabetes with obesity, and increased physical activity/exercise in pregnancy.
  • It states no clear evidence exists for ideal energy-producing nutrient ratios, and that no evidence supports long-term safety of protein intake ≥20% of total energy.
  • Evident from the text: several recommendations rest on consensus rather than trial evidence (e.g., routine foot examination graded "A by consensus," foot care education "B by consensus"), and the document is a guideline synthesis rather than a primary study generating new data.

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Registry

Crossref · 10.1007/s13340-020-00439-5

Cites

451 of 451 references verified0 citation errors · 0 not checkable

Statistics

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Figures

Figure 1 Flowchart outlining the steps in the clinical diagnosis of diabetes mellitus. OGTT, oral glucose tolerance test (Adapted from Seino Y et al. J Jpn Diabetes Soc 2012; 55: 485–504 4 ).
Figure 1 Flowchart outlining the steps in the clinical diagnosis of diabetes mellitus. OGTT, oral glucose tolerance test (Adapted from Seino Y et al. J Jpn Diabetes Soc 2012; 55: 485–504 4 ).CC BY-NC-ND · PubMed Central
Figure 2 Categories of glycemia as indicated by fasting plasma glucose levels and 75 g OGTT results. *1 The impaired fasting glucose (IFG) category refers to individuals with fasting plasma glucose (FPG) levels of 110–125 mg/dL and 2‐h plasma glucose (PG) levels of <140 mg/dL in a 75 g OGTT (WHO), with the caveat, however, that IFG is defined as an FPG 100–125 mg/dL and only FPG is used in the diagnosis of IFG in the American Diabetes Association criteria. *2 Individuals with FPG 100–109 mg/dL are defined as the normal high FPG sub‐category as part of the normal FPG category. It is advisable to perform OGTTs in this population who are shown to be quite heterogeneous in their susceptibility to diabetes or the severity of IGT confirmed at OGTT. *3 As one of the definitions included in the diagnostic criteria proposed by the WHO, IGT is diagnosed in individuals with FPG <126 mg/dL or 2‐h 75 g OGTT PG ranging between 140 and 199 mg/dL.
Figure 2 Categories of glycemia as indicated by fasting plasma glucose levels and 75 g OGTT results. *1 The impaired fasting glucose (IFG) category refers to individuals with fasting plasma glucose (FPG) levels of 110–125 mg/dL and 2‐h plasma glucose (PG) levels of <140 mg/dL in a 75 g OGTT (WHO), with the caveat, however, that IFG is defined as an FPG 100–125 mg/dL and only FPG is used in the diagnosis of IFG in the American Diabetes Association criteria. *2 Individuals with FPG 100–109 mg/dL are defined as the normal high FPG sub‐category as part of the normal FPG category. It is advisable to perform OGTTs in this population who are shown to be quite heterogeneous in their susceptibility to diabetes or the severity of IGT confirmed at OGTT. *3 As one of the definitions included in the diagnostic criteria proposed by the WHO, IGT is diagnosed in individuals with FPG <126 mg/dL or 2‐h 75 g OGTT PG ranging between 140 and 199 mg/dL.CC BY-NC-ND · PubMed Central
Figure 3 Schematic diagram showing the etiology (mechanisms of onset) and pathophysiological stages (phases) of diabetes mellitus (Adapted from Seino Y, et al. J Jpn Diabetes Soc 2012; 55: 485–504 4 ).
Figure 3 Schematic diagram showing the etiology (mechanisms of onset) and pathophysiological stages (phases) of diabetes mellitus (Adapted from Seino Y, et al. J Jpn Diabetes Soc 2012; 55: 485–504 4 ).CC BY-NC-ND · PubMed Central
Figure 4 Treatment of type 2 diabetes patients in non‐insulin‐dependent state. This provides a guide to the management of patients without acute metabolic disorder [i.e., those who had a casual blood glucose level of 250–300 mg/dL or less than 250–300 mg/dL with a negative urinary ketone test]. The glycemic goal should be determined individually depending on the disease condition or age of the patient but is generally set at HbA1c <7.0%. ‘Diet therapy’ and ‘exercise therapy’ are referred to as ‘medical nutrition therapy (MNT)’ and ‘physical activity/exercise’, respectively, elsewhere in this guideline.
Figure 4 Treatment of type 2 diabetes patients in non‐insulin‐dependent state. This provides a guide to the management of patients without acute metabolic disorder [i.e., those who had a casual blood glucose level of 250–300 mg/dL or less than 250–300 mg/dL with a negative urinary ketone test]. The glycemic goal should be determined individually depending on the disease condition or age of the patient but is generally set at HbA1c <7.0%. ‘Diet therapy’ and ‘exercise therapy’ are referred to as ‘medical nutrition therapy (MNT)’ and ‘physical activity/exercise’, respectively, elsewhere in this guideline.CC BY-NC-ND · PubMed Central
Figure 5 Glycemic control targets (see Figure 8 for those for patients 65 years of age or older). The glycemic control target should be determined for each individual in light of his/her age, duration of diabetes, presence of organ damage, risk of hypoglycemia, and access to any support available. *1 Intended for individuals capable of achieving glycemic control with appropriate diet therapy (MNT) or exercise therapy or those capable of achieving glycemic control while on pharmacotherapy without developing hypoglycemia. *2 Defined as HbA1c <7.0% for prevention of diabetic complications, which is assumed to correspond to fasting glucose <130 mg/dL and postprandial 2‐h glucose <180 mg/dL as measured glucose values. *3 Intended for individuals deemed less amenable to treatment intensification due to associated hypoglycemia or for some other reason. *4 All these targets are intended for use by adults except for pregnant women.
Figure 5 Glycemic control targets (see Figure 8 for those for patients 65 years of age or older). The glycemic control target should be determined for each individual in light of his/her age, duration of diabetes, presence of organ damage, risk of hypoglycemia, and access to any support available. *1 Intended for individuals capable of achieving glycemic control with appropriate diet therapy (MNT) or exercise therapy or those capable of achieving glycemic control while on pharmacotherapy without developing hypoglycemia. *2 Defined as HbA1c <7.0% for prevention of diabetic complications, which is assumed to correspond to fasting glucose <130 mg/dL and postprandial 2‐h glucose <180 mg/dL as measured glucose values. *3 Intended for individuals deemed less amenable to treatment intensification due to associated hypoglycemia or for some other reason. *4 All these targets are intended for use by adults except for pregnant women.CC BY-NC-ND · PubMed Central
Figure 6 Blood pressure measurement and procedure for hypertension diagnosis. (Cited from Umemura, S., Arima, H., Arima, S. et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) Hypertens Res. 2019 Sep;42(9):1256. https://doi.org/10.1038/s41440‐019‐0284‐9, with the permission of the JSH).
Figure 6 Blood pressure measurement and procedure for hypertension diagnosis. (Cited from Umemura, S., Arima, H., Arima, S. et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) Hypertens Res. 2019 Sep;42(9):1256. https://doi.org/10.1038/s41440‐019‐0284‐9, with the permission of the JSH).CC BY-NC-ND · PubMed Central
Figure 7 Treatment plan for hypertension complicated by diabetes mellitus. (Cited from Umemura, S., Arima, H., Arima, S. et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) Hypertens Res. 2019 Sep;42(9):1356. https://doi.org/10.1038/s41440‐019‐0284‐9, with the permission of the JSH).
Figure 7 Treatment plan for hypertension complicated by diabetes mellitus. (Cited from Umemura, S., Arima, H., Arima, S. et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) Hypertens Res. 2019 Sep;42(9):1356. https://doi.org/10.1038/s41440‐019‐0284‐9, with the permission of the JSH).CC BY-NC-ND · PubMed Central
Figure 8 Glycemic control targets (HbA1c values) for elderly patients with diabetes. The glycemic target is to be determined for each patient by taking into account his/her age, duration of diabetes, risk for hypoglycemia, and any support available to the patient, as well as the patient’s cognitive function, basic/instrumental ADL, and comorbidities/functional impairments, while noting the potential risk of hypoglycemia that increases with age in each patient. Note 1: Refer to the Japan Geriatrics Society website (https://www.jpn‐geriat‐soc.or.jp/tool/index.html), for the evaluation of the cognitive function, basic ADL (e.g. self‐care abilities such as dressing, mobility, bathing, and toileting), and instrumental ADL (e.g. abilities to maintain an independent household such as shopping, meal preparation, taking medication, and handling finances). In end‐of‐life care, priority is to be given to preventing significant hyperglycemia and subsequent dehydration and acute complications through appropriate therapeutic measures. Note 2: As in other age groups, the glycemic target is set at <7.0% in the elderly for preventing diabetic complications. However, this could be set at <6.0% for those likely to achieve glycemic control through diet and exercise therapy alone or those likely to achieve glycemic control with drug therapy without adverse reactions, or 8.0% for those in whom intensifying therapy may prove difficult. In either case, no lower limit is specified for the glycemic target. A glycemic target of <8.5% may be allowed in patients thought to be in category III and therefore at risk of developing adverse reactions to multi‐drug combination therapy or in those with serious comorbidities or poor social support. Note 3: In patients in whom priority should be given to preventing the onset/progression of diabetic complications due to their duration of disease, the glycemic control target or its lower limit may be set for each elderly patient with appropriate measures in order to prevent severe hypoglycemia. In patients in whom any of these agents was initiated before the age of 65 and whose HbA1c values are shown to fall below their glycemic control targets described above, current treatments are to be continued, with utmost care being taken to avoid potential severe hypoglycemia. Glinides may be classified as drugs unlikely to be associated with severe hypoglycemia, as the onset of severe hypoglycemia varies depending on the type and amount of glinide used in a particular patient relative to the patient’s glucose level. (Cited from Haneda, M., Inagaki, N., Suzuki, R. et al. Glycemic targets for elderly patients with diabetes. Diabetol Int 7, 331–333 (2016). https://doi.org/10.1007/s13340‐016‐0293‐8).
Figure 8 Glycemic control targets (HbA1c values) for elderly patients with diabetes. The glycemic target is to be determined for each patient by taking into account his/her age, duration of diabetes, risk for hypoglycemia, and any support available to the patient, as well as the patient’s cognitive function, basic/instrumental ADL, and comorbidities/functional impairments, while noting the potential risk of hypoglycemia that increases with age in each patient. Note 1: Refer to the Japan Geriatrics Society website (https://www.jpn‐geriat‐soc.or.jp/tool/index.html), for the evaluation of the cognitive function, basic ADL (e.g. self‐care abilities such as dressing, mobility, bathing, and toileting), and instrumental ADL (e.g. abilities to maintain an independent household such as shopping, meal preparation, taking medication, and handling finances). In end‐of‐life care, priority is to be given to preventing significant hyperglycemia and subsequent dehydration and acute complications through appropriate therapeutic measures. Note 2: As in other age groups, the glycemic target is set at <7.0% in the elderly for preventing diabetic complications. However, this could be set at <6.0% for those likely to achieve glycemic control through diet and exercise therapy alone or those likely to achieve glycemic control with drug therapy without adverse reactions, or 8.0% for those in whom intensifying therapy may prove difficult. In either case, no lower limit is specified for the glycemic target. A glycemic target of <8.5% may be allowed in patients thought to be in category III and therefore at risk of developing adverse reactions to multi‐drug combination therapy or in those with serious comorbidities or poor social support. Note 3: In patients in whom priority should be given to preventing the onset/progression of diabetic complications due to their duration of disease, the glycemic control target or its lower limit may be set for each elderly patient with appropriate measures in order to prevent severe hypoglycemia. In patients in whom any of these agents was initiated before the age of 65 and whose HbA1c values are shown to fall below their glycemic control targets described above, current treatments are to be continued, with utmost care being taken to avoid potential severe hypoglycemia. Glinides may be classified as drugs unlikely to be associated with severe hypoglycemia, as the onset of severe hypoglycemia varies depending on the type and amount of glinide used in a particular patient relative to the patient’s glucose level. (Cited from Haneda, M., Inagaki, N., Suzuki, R. et al. Glycemic targets for elderly patients with diabetes. Diabetol Int 7, 331–333 (2016). https://doi.org/10.1007/s13340‐016‐0293‐8).CC BY-NC-ND · PubMed Central

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145 Not checked yet · 72 No basis given · 10 Own interpretation · 3 Own method · accuracy not yet measured

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  • It may state two separate claims as one. 58
  • Probably not a substantial claim. 18
  • The quote only partly states this claim. 1
72 of 72

  • The paper relies on this without support.

    The BMI value least associated with all-cause mortality varies with age and falls within a certain range.

    “Given that the body mass index (BMI) value least associated with all‐cause mortality is expected to vary with age and fall within a certain range, the target body weight is to be calculated for each patient by the following formula:”

  • The paper relies on this without support.

    Insulin has a wide-ranging action affecting not only glucose metabolism but lipid and protein metabolism, all of which are closely linked.

    “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.”

  • The paper relies on this without support.

    The treatment strategy for diabetes varies depending on disease type, disease condition, patient age, metabolic abnormalities, and status of diabetic complications.

    “The treatment strategy for diabetes may vary depending on the disease type, disease condition, patient age, metabolic abnormalities, and status of diabetic complications.”

  • The paper relies on this without support.

    Obesity is associated with abnormal eating behavior, such as speed eating, impulse eating, and eating between meals from post-lunch to nighttime, which can be problematic in many patients with type 2 diabetes and obesity.

    “Obesity is associated with abnormal eating behavior, such as speed eating characterized by an excessive intake of energy over a short time, impulse eating, and eating between meals from post‐lunch to nighttime, can be problematic in many of these patients.”

  • The paper relies on this without support.

    Behavioral enhancement through routine motivation measures is effective in maintaining desired behavioral changes.

    “Behavioral enhancement through routine motivation measures is thought to be effective in maintaining desired behavioral changes.”

  • The paper relies on this without support.

    SGLT2 inhibitor is associated with a weight loss of about 3 kg in obese patients with type 2 diabetes.

    “SGLT2 inhibitor is shown to be associated with a weight loss of about 3 kg in obese patients with type 2 diabetes.”

  • The paper relies on this without support.

    Concomitant hypertension in patients with diabetes is a risk factor for microangiopathy, such as diabetic neuropathy, diabetic retinopathy, and diabetic nephropathy.

    “Concomitant hypertension in patients with diabetes is a risk factor for microangiopathy, such as diabetic neuropathy, diabetic retinopathy, and diabetic nephropathy (see also relevant pages for diabetic neuropathy, diabetic retinopathy, and diabetic nephropathy).”

  • The paper relies on this without support.

    Hypoglycemia is likely to be associated with cognitive impairment.

    “Hypoglycemia is likely to be associated with cognitive impairment.”

  • The paper relies on this without support.

    Hypoglycemia may not be recognized in patients below 6–7 years of age and may therefore become severe.

    “Hypoglycemia may not be recognized in patients below 6–7 years of age and may therefore become severe.”

  • The paper relies on this without support.

    Persistent hyperglycemia is associated with cognitive impairment.

    “It is also to be noted that persistent hyperglycemia is associated with cognitive impairment.”
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Citations

Cites

Items 401–451 of 451

Research works printed but not linked: 29

  1. Kaku K, Tajima N, Kawamori R, et al. Melbin Observational Research (MORE) study of metformin therapy in patients with type 2 diabetes mellitus. J Jpn Diabetes Soc. 2006;49:325–31 (in Japanese).
  2. Iwakura T, Fujimoto K, Tahara Y, et al. A case of severe hypoglycemia induced by sitagliptin added to ongoing glimepiride therapy in patients with type 2 diabetes. J Jpn Diabetes Soc. 2010;53:505–8 (in Japanese).
  3. Han A, Katoh S, Nemoto M, et al. Effect of combination therapy of premixtured 50 R and voglibose in patients with type 2 diabetes. J Jpn Diabetes Soc. 2004;47:137–40 (in Japanese).
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  10. Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary, P et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977–86 [level 1] · DOI · Paper page
  11. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995;28:103–17 [level 2] · DOI · Paper page
  12. Ismail-Beigi F, Craven T, Banerji MA, et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet. 2010;376:419–30 [level 1] · DOI · Paper page
  13. Stratton IM, Adler A, Meil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. 2000;321:405–2 [level 2] · DOI · Paper page
  14. Ueki K, Sasako T, Okazaki Y, et al. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:951–64. · DOI · Paper page
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  22. Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006;CD002968 [level 1+] · DOI · Paper page
  23. Gaede P, Lund-Andersen H, Parving HH, et al. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358:580–91 [level 2] · DOI · Paper page
  24. Ueki K, Sasako T, Okazaki Y, et al.; J-DOIT3 Study Group. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:951–64 [level 1]
  25. Hiramatsu Y. Workshop “Gestational diabetes mellitus and self monitoring of blood glucose (SMBG)”. Diabetes Pregnancy. 2015;15:89–90 (in Japanese).
  26. Hiramatsu Y, Haneda M, et al. The joint committee with the Japan Society of Diabetes and Pregnancy and the Japan Diabetes Society “An abnormal glucose metabolism during pregnancy and the standardization of its diagnostic criteria.”. J Jpn Diabetes Soc. 2015;58:801–3 (in Japanese).
  27. Matsuura N, Takeuchi M, Amemiya S, et al. Trial of metformin clinical trial of metformin monotherapy in children and adolescents with type 2 diabetes mellitus in Japan. J Jpn Diabet Soc. 2008;51(5):427–34.
  28. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403. · DOI · Paper page
  29. Loke YK, Singh S, Furberg CD. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ. 2009;180:32–9. · DOI

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Metadata

Authors
Araki, E., Goto, A., Kondo, T., Noda, M., Noto, H., Origasa, H., Osawa, H., Taguchi, A., Tanizawa, Y., Tobe, K., & Yoshioka, N.
Affiliations
  • Kumamoto University (JP)
  • Yokohama City University (JP)
  • Kumamoto University Hospital (JP)
  • International University of Health and Welfare Ichikawa Medical Center (JP)
  • St. Luke's International Hospital (JP)
  • University of Toyama (JP)
  • Ehime University (JP)
  • Yamaguchi University (JP)
  • NTT Medical Center Sapporo (JP)
Corresponding author
Araki, Eiichi
ORCID
Venue
Diabetology International
Publisher
Springer Science and Business Media LLC
Published
2020-07
Volume
11
Issue
3
Pages
165-223
ISSN
  • 2190-1678 (ISSN-L)
  • 2190-1686
DOI
10.1007/s13340-020-00439-5
PMC
PMC7378414
OpenAlex
W3044697752
Cited by
545
References
451
Citations by year
2026: 27 · 2025: 86 · 2024: 116 · 2023: 123 · 2022: 107 · 2021: 71 · 2020: 11
FWCI
11.97
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetology International (publishedVersion)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Japan Society for the Promotion of Science (18K08482)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
diabetes mellitus, diabetes management, glycemic control, diabetes complications

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