Skip to main content

Advertisement

Log in

Japanese Clinical Practice Guideline for Diabetes 2016

Diabetology International Aims and scope Submit manuscript

A Correction to this article was published on 20 December 2019

A Correction to this article was published on 04 December 2018

This article has been updated

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Excerpt from: The Japanese Society of Hypertension, Guidelines for the Treatment of Hypertension, 2014, P.78

Fig. 7

Change history

  • 04 December 2018

    Correction to: Diabetology International.

  • 04 December 2018

    Correction to: Diabetology International.

  • 04 December 2018

    Correction to: Diabetology International.

  • 04 December 2018

    Correction to: Diabetology International.

  • 04 December 2018

    Correction to: Diabetology International.

  • 04 December 2018

    Correction to: Diabetology International.

  • 20 December 2019

    In the original version of the article, Table��5 was published incorrectly.

  • 20 December 2019

    In the original version of the article, Table��5 was published incorrectly.

References

1 Guideline for the diagnosis of diabetes mellitus

  1. Kosaka K,Akanuma Y, Goto Y, et al. Report of Committee on the classification and diagnostic criteria of diabetes mellitus.J Jpn Diabetes Soc. 1982;25:859–66 (in Japanese).

  2. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 1997;20:1183–97.

  3. World Health Organization. Report of a WHO consultation: definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus. Geneva: World Health Organization Department of Noncommunicable Disease Surveillance. 1999. http://www.staff.ncl.ac.uk/philip.home/who_dmc.htm.

  4. Kuzuya T, Nakagawa S, Satoh J, et al. Report of the Committee of Japan Diabetes Society on the classification and diagnostic criteria of diabetes mellitus. J Jpn Diabetes Soc. 1999;42:385–404 (in Japanese).

  5. Seino Y, Nanjo K, Tajima N. et al. Report of the Committee on the classification and diagnostic criteria of diabetes mellitus: The Committee of the Japan Diabetes Society on the diagnostic criteria of diabetes mellitus. Diabetol Int. 2010;1: 2.

  6. Kadowaki T, Haneda M, Tominaga M, et al. Report of the Japan Diabetes Society’s Committee on the diagnostic criteria for diabetes mellitus and glucose metabolism disorder—a new category of fasting plasma glucose values : “high-normal”. J Jpn Diabetes Soc. 2008;51:281–3 (in Japanese).

  7. Kawasaki E, Maruyama T, Imagawa A. et al. Diagnostic criteria for acute-onset type 1 diabetes mellitus (2012): Report of the Committee of Japan Diabetes Society on the Research of Fulminant and Acute-onset Type 1 Diabetes Mellitus. Diabetol Int. 2013;4:221.

  8. Tanaka S, Ohmori M, Awata T. et al. Erratum to: Diagnostic criteria for slowly progressive insulin-dependent (type 1) diabetes mellitus (SPIDDM) (2012): report by the Committee on Slowly Progressive Insulin-Dependent (Type 1) Diabetes Mellitus of the Japan Diabetes Society. Diabetol Int. 2015;6:149.

  9. Imagawa A., Hanafusa T., Awata T. et al. Report of the Committee of the Japan Diabetes Society on the Research of Fulminant and Acute-onset Type 1 Diabetes Mellitus: New Diagnostic Criteria of Fulminant Type 1 Diabetes Mellitus (2012). Diabetol Int. 2012;3:179–183.

  10. Imagawa A, Hanafusa T.et al. A nationwide survey of fulminant type 1 diabetes mellitus J Jpn Soc Inten Med. 2013;102:1829–1835 (in Japanese)

2 Goals and strategies for diabetes management

  1. United Kingdom Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS33). Lancet 1998;352:837–53 (level 1+).

  2. Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes—3-year outcome. N Engl J Med. 2014;370:2002–13 (level. 1).

  3. Sone H, Tanaka S, Tanaka S, et al. Serum level of triglycerides is a potent risk factor comparable to LDL cholesterol for coronary heart disease in Japanese patients with type 2 diabetes: subanalysis of the Japan Diabetes Complications Study (JDCS). J Clin Endocrinol Metab. 2011;96:3448–3456 (level 2).

3 Medical nutrition therapy (MNT)

  1. Nakagawa Y, Ishikawa Y, Watanabe K, et al. Impact of the duration of diabetes and frequency of counseling on the effectiveness of dietitian-led medical nutrition therapy in patients with type 2 diabetes. J Jpn Diabetes Soc. 2014;57:813–9 (in Japanese) (level 3).

  2. Pastors JG, Warshaw H, Daly A et al. The evidence for the effectiveness of medical nutrition therapy in diabetes management. Diabetes Care 2002;25:608–13 (level 3).

4 Physical activity/exercise

  1. American Diabetes Association. Foundations of care and comprehensive medical evaluation. Sec. 3. In: Standards of Medical Care in Diabetes-2016. Diabetes Care 2016;39(Suppl 1):S23–35.

  2. Marwick TH, Hordern MD, Miller T, et al. Exercise training for type 2 diabetes mellitus: impact on cardiovascular risk: a scientific statement from the American Heart Association. Circulation. 2009;119:3244–62.

  3. Umpierre D, Ribeiro PA, Kramer CK et al: Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011;305:1790–9 (level 1).

  4. Boulé NG, Kenny GP, Haddad E, et al. Meta-analysis of the effect of structured exercise training on cardiorespiratory fitness in type 2 diabetes mellitus. Diabetologia. 2003;46:1071–81 (level 1).

  5. Kelley GA, Kelley KS: Effects of aerobic exercise on lipids and lipoproteins in adults with type 2 diabetes: a meta-analysis of randomized-controlled trials. Public Health. 2007;121:643–55 (level 1).

  6. Schwingshackl L, Missbach B, Dias S, et al. Impact of different training modalities on glycaemic control and blood lipids in patients with type 2 diabetes. a systematic review and network meta-analysis. Diabetologia. 2014;57:1789–97 (level 1).

  7. Tonoli C, Heyman E, Roelands B, et al. Effects of different types of acute and chronic (training) exercise on glycaemic control in type 1 diabetes mellitus: a meta-analysis. Sports Med. 2012;42:1059–80 (level 3).

  8. Kennedy A, Nirantharakumar K, Chimen M, et al. Does exercise improve glycaemic control in type 1 diabetes? a systematic review and meta-analysis. PLoS One 2013;8:e58861. https://doi.org/10.1371/journal.pone.0058861 (level 3).

  9. Chiang JL, Kirkman MS, Laffel LM, et al. Type 1 diabetes sourcebook authors: type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care. 2014;37:2034–54.

5 Treatment with glucose-lowering agents (excluding insulin)

  1. United Kingdom Prospective Diabetes Study (UKPDS) 13. Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. BMJ. 1995;310:83–8 (level 1+).

  2. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–12 (level 2).

  3. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–53 (level 1+).

  4. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;381:140–9.

  5. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352:854–65 (level 1+).

  6. Selvin E, Bolen S, Yeh HC, et al. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008;168:2070–80 (level 1+).

  7. Zinman B, Wanner C, Lachin, JM, et al. Empagliflozin cardiovascular outcomes, and mortality in type 2 diabetes (EMPA-REG OUTCOME). N Engl J Med. 2015;373:2117–28 (level 1+).

  8. Bennett WL, Wilson LM, Bolen S, et al. AHRQ comparative effectiveness reviews. oral diabetes medications for adults with type 2 diabetes: an update. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 (level 2).

  9. 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, level 2).

  10. Meier C, Kraenzlin ME, Bodmer M, et al. Use of thiazolidinediones and fracture risk. Arch Intern Med. 2008;168:820–5 (level 3).

  11. 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 (level 2).

  12. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009;373:2125–35 (level 1+).

  13. Colhoun HM, Livingstone SJ, Looker HC, et al. Hospitalised hip fracture risk with rosiglitazone and pioglitazone use compared with other glucose-lowering drugs. Diabetologia. 2012;55:2929–37 (level 3).

  14. Nissen SE, Nicholls SJ, Wolski K, et al. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA. 2008;299:1561–73 (level 1).

  15. Tajima N, Kadowaki T, Odawara M, et al. Addition of sitagliptin to ongoing glimepiride therapy in Japanese patients with type 2 diabetes over 52 weeks leads to improved glycemic control. Diabetol Int. 2011;2:32–44 (level 1).

  16. Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014;16:418–25 (level 1).

  17. Hermansen K, Kipnes M, Luo E, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9:733–45 (level 1).

  18. 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, level 4).

  19. Kadowaki T, Tajima N, Odawara M, et al. Efficacy and safety of sitagliptin add-on therapy in Japanese patients with type 2 diabetes on insulin monotherapy. Diabetol Int. 2013;4:160–72 (level 1).

  20. Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a metaanalysis of randomized clinical trials. Diabetes Obes Metab. 2014;16:48–56 (level 1).

  21. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes (EXAMINE). N Engl J Med. 2013;369:1327–35 (level 1+).

  22. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus (SAVOR). N Engl J Med. 2013;369:1317–26 (level 1+).

  23. Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes (TECOS). N Engl J Med. 2015;373:232–42 (level 1+).

  24. Kaku K, Rasmussen MF, Clauson P, et al. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:341–7 (level 1).

  25. Seino Y, Min KW, Niemoeller E, et al, Investigators EG-LAS. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14:910–7 (level 1).

  26. Monami M, Dicembrini I, Nardini C, et al. Glucagon-like peptide-1 receptor agonists and pancreatitis: a meta-analysis of randomized clinical trials. Diabetes Res Clin Pract. 2014;103:269–75 (level 1).

  27. Pfeffer MA, Claggett B, Diaz R. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA). N Engl J Med. 2015;373:2247–57 (level 1+).

  28. Monami M, Nardini C, Mannucci E. Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2014;16:457–66 (level 1).

  29. Vasilakou D, Karagiannis T, Athanasiadou E, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159:262–74 (level 1).

  30. Bolinder J, Ljunggren O, Johansson L, et al. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014;16:159–69 (level 1).

  31. Charpentier G, Fleury F, Kabir M, et al. Improved glycaemic control by addition of glimepiride to metformin monotherapy in type 2 diabetic patients. Diabet Med. 2001;18:828–34 (level 1).

  32. Moses R, Slobodniuk R, Boyages S, et al. Effect of repaglinide addition to metformin monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 1999;22:119–24 (level 1).

  33. Van Gaal L, Maislos M, Schernthaner G, et al. Miglitol combined with metformin improves glycaemic control in type 2 diabetes. Diabetes Obes Metab. 2001;3:326–31 (level 1).

  34. Einhorn D, Rendell M, Rosenzweig J, et al. Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. Clin Ther. 2000;22:1395–409 (level 1).

  35. Taskinen MR, Rosenstock J, Tamminen I, et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2011;13:65–74 (level 1).

  36. DeFronzo RA, Ratner RE, Han J et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28:1092–100 (level 1).

  37. Derosa G, Salvadeo SA, D’Angelo A, et al. Metabolic effect of repaglinide or acarbose when added to a double oral antidiabetic treatment with sulphonylureas and metformin: a double-blind, cross-over, clinical trial. Curr Med Res Opin. 2009;25:607–15 (level 1).

  38. Scheen AJ, Tan MH, Betteridge DJ, et al. Long-term glycaemic control with metformin-sulphonylurea pioglitazone triple therapy in PROactive (PROactive 17). Diabet Med. 2009;26:1033–9 (level 3).

  39. Lukashevich V, Prato SD, Araga M, et al. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014;165:403–9 (level 1).

  40. Kendall DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005;285:1083–91 (level 1).

  41. Wilding JP, Charpentier G, Hollander P, et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;6712:1267–82 (level 1).

6 Insulin therapy

  1. The Diabetes Control and Complications Trial (DCCT) Research Group. Early worsening of diabetic retinopathy in the diabetes control and complications trial. Arch Ophthalmol. 1998;116:874–86 (level 1+).

  2. Takahashi Y, Takayama S, Ito T, et al. Clinical features of eighty-six diabetic patients with post-treatment painful neuropathy. J Jpn Diabetes Soc. 1998;41:165–70 (in Japanese, level 4).

  3. United Kingdom Prospective Diabetes Study (UKPDS) Group. United Kingdom Prospective Diabetes Study 24: a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. Ann Intern Med. 1998;128:165–75 (level 1).

  4. The Diabetes Control and Complications Trial (DCCT) Research Group. 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+).

  5. The Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive diabetes therapy on measures of autonomic nervous system function in the Diabetes Control and Complications Trial (DCCT). Diabetologia. 1998;41:416–23 (level 1+).

  6. Lawson ML, Gerstein HC, Tsui E, et al. Effect of intensive therapy on early macrovascular disease in young individuals with type 1 diabetes: a systematic review and meta-analysis. Diabetes Care. 1999;22(Suppl 2):B35–9 (level 1).

  7. Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353:2643–53 (level 1+).

  8. 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 1).

  9. United Kingdom Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–53 (level 1+).

  10. Shichiri M, Kishikawa H, Ohkubo Y, et al. Long-term results of the Kumamoto Study on optimal diabetes control in type 2 diabetic patients. Diabetes Care. 2000;23(Suppl 2):B21–9 (level 1).

  11. Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007;357:1716–30 (level 1).

  12. Liebl A, Prager R, Binz K, et al. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER study: a randomized controlled trial. Diabetes Obes Metab. 2009;11:45–52 (level 1).

  13. Feinglos MN, Thacker CR, Lobaugh B, et al. Combination insulin and sulfonylurea therapy in insulin requiring type 2 diabetes mellitus. Diabetes Res Clin Pract. 1998;39:193–9 (level 1).

  14. Wright A, Burden AC, Paisey RB, et al. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK Prospective Diabetes Study (UKPDS 57). Diabetes Care. 2002;25:330–6 (level 1).

  15. Ozbek M, Erdogan M, Karadeniz M, et al. Preprandial repaglinide decreases exogenous insulin requirements and HbA1c levels in type 2 diabetic patients taking intensive insulin treatment. Acta Diabetol. 2006;43:148–51 (level 3).

  16. De Luis DA, Aller R, Cuellar L, et al. Effect of repaglinide addition to NPH insulin monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2001;24:1844–55 (level 3).

  17. Yamada S, Watanabe M, Funae O, et al. Effect of combination therapy of a rapid-acting insulin secretagogue (glinide) with premixed insulin in type 2 diabetes mellitus. Intern Med. 2007;46:1893–7 (level 3).

  18. Avilés-Santa L, Sinding J, Raskin P. Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1999;131:182–8 (level 1).

  19. Relimpio F, Pumar A, Losada F, et al. Adding metformin versus insulin dose increase in insulin-treated but poorly controlled type 2 diabetes mellitus: an open-label randomized trial. Diabet Med. 1998;15:997–1002 (level 1).

  20. Yki-Järvinen H, Ryysy L, Nikkilä K, et al. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus: a randomized, controlled trial. Ann Intern Med. 1999;130:389–96 (level 1).

  21. Ponssen HH, Elte JW, Lehert P, et al. Combined metformin and insulin therapy for patients with type 2 diabetes mellitus. Clin Ther. 2000;22:709–18 (level 1).

  22. Juntti-Berggren L, Pigon J, Hellström P, et al. Influence of acarbose on post-prandial insulin requirements in patients with type 1 diabetes. Diabetes Nutr Metab. 2000;13:7–12 (level 1).

  23. 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, level 1).

  24. Schwartz S, Raskin P, Fonseca ,V et al. Effect of troglitazone in insulin-treated patients with type II diabetes mellitus: Troglitazone and Exogenous Insulin Study Group. N Engl J Med. 1998;338:861–6 (level 1).

  25. Mattoo V, Eckland D, Widel M, et al. Metabolic effects of pioglitazone in combination with insulin in patients with type 2 diabetes mellitus whose disease is not adequately controlled with insulin therapy: results of a six-month, randomized, double-blind, prospective, multicenter, parallel-group study. Clin Ther. 2005;27:554–67 (level 1).

  26. Bhat R, Bhansali A, Bhadada S, et al. Effect of pioglitazone therapy in lean type 1 diabetes mellitus. Diabetes Res Clin Pract. 2007;78:349–54 (level 1).

  27. Raskin P, Rendell M, Riddle MC, et al. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care. 2001;24:1226–32 (level 1).

  28. Vilsbøll T, Rosenstock J, Yki-Järvinen H, et al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:167–77 (level 1).

  29. Eng C, Kramer CK, Zinman B, Retnakaran R. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet. 2014;384:2228–34 (level 1).

  30. Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359:1577–89 (level 1+).

  31. The ACCORD Study Group. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011;364:818–28 (level 1+).

7 Diabetes Self-management education and support and education for the self-management of diabetes

  1. Tshiananga JK, Kocher S, Weber C, et al. The effect of nurse-led diabetes self-management education on glycosylated hemoglobin and cardiovascular risk factors: a meta-analysis. Diabetes Educ. 2012;38:108–23 (level 1).

  2. Minet L, Moller S, Vach W, et al. Mediating the effect of self-care management intervention in type 2 diabetes: a meta-analysis of 47 randomised controlled trials. Patient Educ Couns. 2010;80:29–41 (level 1).

  3. Deakin T, McShane CE, Cade JE. Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005:CD003417 (level 1).

  4. Duke SA, Colagiuri S, Colagiuri R. Individual patient education for people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2009:CD005268 (level 1).

  5. The Diabetes Control and Complications Trial Research Group. 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).

  6. Karter AJ, Ackerson LM, Darbinian JA, et al. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med. 2001;111:1–9 (level 3).

  7. Avery L, Flynn D, van Wersch A, et al. Changing physical activity behavior in type 2 diabetes: a systematic review and meta-analysis of behavioral interventions. Diabetes Care. 2012;35:2681–9 (level 1).

  8. Young RJ, Taylor J, Friede T, et al. Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2005;28:278–82 (level 1).

  9. Katon WJ, Lin EH, Von Korff M, et al. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010;363:2611–20 (level 1).

  10. Huang Y, Wei X, Wu T, et al. Collaborative care for patients with depression and diabetes mellitus: a systematic review and meta-analysis. BMC Psychiatry. 2013;13:260 (level 1).

8 Diabetic retinopathy

  1. Klein R, Klein BE, Moss SE, et al. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: IX. Fouryear incidence and progression of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1989;107:237–43 (level 2).

  2. Klein R, Klein BE, Moss SE, et al. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: X. Fouryear incidence and progression of diabetic retinopathy when age at diagnosis is 30 years or more. Arch Ophthalmol. 1989;107:244–9 (level 2).

  3. Younis N, Broadbent DM, Vora JP, et al. Incidence of sight-threatening retinopathy in patients with type 2 diabetes in the Liverpool Diabetic Eye Study: a cohort study. Lancet. 2003;361:195–200 (level 2).

  4. Misra A, Bachmann MO, Greenwood RH, et al. Trends in yield and effects of screening intervals during 17 years of a large UK community-based diabetic retinopathy screening programme. Diabet Med. 2009;26:1040–7 (level 2).

  5. Diabetes Control and Complications Trial Research Group. 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+).

  6. United Kingdom Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–53 (level 1+).

  7. Chew EY, Ambrosius WT, Davis MD, et al. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010;363:233–44 (level 1+).

  8. United Kingdom Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317:703–13 (level 1+).

  9. UK Prospective Diabetes Study (UKPDS) Group. Risks of progression of retinopathy and vision loss related to tight blood pressure control in type 2 diabetes mellitus: UKPDS 69. Arch Opthalmol. 2004;122:1631–40 (level 1+).

  10. Keech AC, Mitchell P, Summanen PA, et al. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet. 2007;370:1687–97 (level 1+).

  11. The Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. Ophthalmology. 1978;85:82–106 (level 1).

  12. Evans JR, Michelessi M, Virgili G. Laser photocoagulation for proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2014;11:CD011234 (level 1).

  13. Chew EY, Mills JL, Metzger BE, et al. Metabolic control and progression of retinopathy: the diabetes in early pregnancy study. National Institute of Child Health and Human Development Diabetes in Early Pregnancy Study. Diabetes Care. 1995;18:631–7 (level 2).

  14. Soubrane G, Canivet J, Coscas G. Influence of pregnancy on the evolution of background retinopathy. Int Ophthalmol. 1985;8:249–55 (level 2).

  15. Diabetes Control and Complications Trial Research Group. Effect of pregnancy on microvascular complications in the diabetes control and complications trial. Diabetes Care. 2000;23:1084–91 (level 3).

  16. Rossing P, Hougaard P, Parving HH. Risk factors for development of incipient and overt diabetic nephropathy in type 1 diabetic patients: a 10-year prospective observational study. Diabetes Care. 2002;25:859–64 (level 2).

  17. Cheung N, Wang JJ, Klein R, et al. Diabetic retinopathy and the risk of coronary heart disease: the Atherosclerosis Risk in Communities Study. Diabetes Care. 2007;30:1742–6 (level 2).

  18. Cheung N, Rogers S, Couper DJ, et al. Is diabetic retinopathy an independent risk factor for ischemic stroke? Stroke. 2007;38:398–401 (level 2).

  19. Gerstein HC, Ambrosius WT, Danis R, et al. Diabetic retinopathy, its progression, and incident cardiovascular events in the ACCORD trial. Diabetes Care. 2013;36:1266–71 (level 3).

  20. Kawasaki R, Tanaka S, Tanaka S, et al. Risk of cardiovascular diseases is increased even with mild diabetic retinopathy: the Japan diabetes complications study. Ophthalmology. 2013;120:574–82 (level 2).

9 Diabetic nephropathy

  1. Katayama S, Moriya T, Tanaka S, et al. Low transition rate from normo- and low microalbuminuria to proteinuria in Japanese type 2 diabetic individuals: the Japan Diabetes Complications Study (JDCS). Diabetologia. 2011;54:1025–31 (level 2).

  2. 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 1).

  3. Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560–72 (level 1+).

  4. Shurraw S, Hemmelgarn B, Lin M, et al. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: a population-based cohort study. Arch Intern Med. 2011;171:1920–7 (level 3).

  5. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317:703–13 (level 1+).

  6. Makino H, Haneda M, Babazono T, et al. Prevention of transition from incipient to overt nephropathy with telmisartan in patients with type 2 diabetes. Diabetes Care. 2007;30:1577–8 (level 1+).

  7. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:85–60 (level 1+).

  8. Colhoun HM, Betteridge DJ, Durrington PN, et al. Effects of atorvastatin on kidney outcomes and cardiovascular disease in patients with diabetes: an analysis from the Collaborative Atorvastatin Diabetes Study (CARDS). Am J Kidney Dis. 2009;54:810–9 (level 1+).

  9. Kimura S, Inoguchi T, Yokomizo H, et al. Randomized comparison of pitavastatin and pravastatin treatment on the reduction of urinary albumin in patients with type 2 diabetic nephropathy. Diabetes Obes Metab. 2012;14:666–9 (level 1+).

  10. Haneda M, Kikkawa R, Sakai H, et al. Antiproteinuric effect of candesartan cilexetil in Japanese subjects with type 2 diabetes and nephropathy. Diabetes Res Clin Pract. 2004;66:87–95 (level 1).

  11. Casas JP, Chua W, Loukogeorgakis S et al. Effect of inhibitors of the renin–angiotensin system and other antihypertensive drugs on renal outcomes: systematic review and meta-analysis. Lancet. 2005;366:2026–33 (level 1+).

  12. Suckling RJ, He FJ, Macgregor GA. Altered dietary salt intake for preventing and treating diabetic kidney disease. Cochrane Database Syst Rev. 2010:CD006763 (level 1).

  13. Imanishi M, Yoshioka K, Okumura M, et al. Sodium sensitivity related to albuminuria appearing before hypertension in type 2 diabetic patients. Diabetes Care. 2001;24:111–6 (level 2).

  14. Hansen HP, Tauber-Lassen E, Jensen BR, et al. Effect of dietary protein restriction on prognosis in patients with diabetic nephropathy. Kidney Int. 2002;62:220–8 (level 1).

  15. Koya D, Haneda M, Inomata S, et al. Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: a randomised controlled trial. Diabetologia. 2009;52:2037–45 (level 1).

  16. Kuriyama S, Tomonari H, Yoshida H, et al. Reversal of anemia by erythropoietin therapy retards the progression of chronic renal failure, especially in nondiabetic patients. Nephron. 1997;77:176–85 (level 2).

  17. Matsuo S, Imai E, Horio M, et al. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009;5:982–92.

  18. Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24:302–8.

  19. Horio M, Imai E, Yasuda Y. Collaborators Developing the Japanese Equation for Estimated GFR: GFR estimation using standardized serum cystatin C in Japan. Am J Kidney Dis. 2013;61:197–203.

10 Diabetic neuropathy

  1. Hotta N, Toyoda R, et al. Diabetic neuropathy. Kanehara, Tokyo ;1996. p. 145–54 (in Japanese).

  2. Boulton AJ, Vinik AI, Arezzo JC, et al. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005;28:956–62.

  3. Tesfaye S, Chaturvedi N, Eaton SE, et al. Vascular risk factors and diabetic neuropathy. N Engl J Med 2005;352:341–50 (level 2).

  4. The Diabetes Control and Complications Trial (DCCT) Research Group. 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+).

  5. 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 1).

  6. Max MB, Culnane M, Schafer SC, et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology 1987;37:589–96 (level 1).

  7. Freeman R, Durso-Decruz E, Emir B. Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care. 2008;31:1448–54 (level 1).

  8. Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabet Med. 2011;28:109–16 (level 1).

  9. Pritchett YL, McCarberg BH, Watkin JG, et al. Duloxetine for the management of diabetic peripheral neuropathic pain: response profile. Pain Med. 2007;8:397–409 (level 1).

  10. Yasuda H, Hotta N, Nakao K, et al. Superiority of duloxetine to placebo in improving diabetic neuropathic pain: results of a randomized controlled trial in Japan. J Diabetes Investig. 2011;2:132–9 (level 1).

  11. Charles M, Soedamah-Muthu SS, Tesfaye S, et al. Low peripheral nerve conduction velocities and amplitudes are strongly related to diabetic microvascular complications in type 1 diabetes: the EURODIAB Prospective Complications Study. Diabetes Care. 2010;33:2648–53 (level 4).

  12. Tesfaye S, Boulton AJ, Dyck PJ et al. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010;33:2285–2293

  13. Japanese Study Group on Diabetic Neuropathy. Simplified diagnostic criteria and clinical staging of diabetic polyneuropathy. Peripheral Nerve. 2012;23:109–111

11 Diabetic foot

  1. International Working Group on the Diabetic Foot (IWGDF). Guidance 2015. http://iwgdf.org/guidelines-2/.

  2. Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders: a clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006;45:S1–66.

  3. Resnick HE, Carter EA, Lindsay R, et al. Relation of lower-extremity amputation to all-cause and cardiovascular disease mortality in American Indians: the Strong Heart Study. Diabetes Care. 2004;27:1286–93 (level 2).

  4. Krishinan S, Nash F, Baker N, et al. Reduction in diabetic amputations over 11 years in a defined UK population benefits of multidisciplinary team work and continuous prospective audit. Diabetes Care. 2008;31:99–101 (level 2).

  5. Malone JM, Snyder M, Anderson G, et al. Prevention of amputation by diabetic education. Am J Surg. 1989;1508:520–4 (level 1).

  6. Stratton IM, Adler A, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–12 (level 2).

  7. Edmonds ME, Blundell MP, Morris ME, et al. Improved survival of the diabetic foot: the role of a specialized foot clinic. Q J Med. 1986;60:763–71 (level 4).

  8. Armstrong DG, Bharara M, White M, et al. The impact and outcomes of establishing an integrated interdisciplinary surgical team to care for the diabetic foot. Diabetes Metab Res Rev. 2012;28:514–8 (level 3).

  9. Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011;58:2020–45.

  10. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54:e132–73.

  11. Holstein P, Ellitsgaard N, Olsen BB, et al. Decreasing incidence of major amputations in people with diabetes. Diabetologia. 2000;43:844–7 (level 4).

  12. Valensi P, Girod I, Baron F, et al. Quality of life and clinical correlates in patients with diabetic foot ulcers. Diabetes Metab. 2005;31:263–71 (level 4).

  13. Ribu L, Birkeland K, Hanestad BR, et al. A longitudinal study of patients with diabetes and foot ulcers and their health-related quality of life: wound healing and quality-of-life changes. J Diabetes Complications. 2008;22:400–7 (level 2).

  14. Brownrigg JR, Davey J, Holt PJ, et al. The association of ulceration of the foot with cardiovascular and all cause mortality in patients with diabetes. Diabetologia. 2012;55:2906–12 (level 2).

12 Diabetic macroangiopathy

  1. Gaede P, Vedel P, Larsen N, et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348:383–93 (level 1).

  2. Miller ME, Williamson JD, Gerstein HC, et al, ACCORD Investigators. Effects of randomization to intensive glucose control on adverse events, cardiovascular disease, and mortality in older versus younger adults in the ACCORD Trial. Diabetes Care. 2014;37:634–43 (level 3).

  3. Wing RR, Look AHEAD Research Group. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010;170:1566–75 (level 1).

  4. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–12 (level 2).

  5. Adler AI, Stratton IM, Neil HA, et al. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000;321:412–9 (level 2).

  6. de Vries FM, Denig P, Pouwels KB et al. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis. Drugs 2012;72:2365–73 (level 1).

  7. de Vries FM, Kolthof J, Postma MJ, et al. Efficacy of standard and intensive statin treatment for the secondary prevention of cardiovascular and cerebrovascular events in diabetes patients: a meta-analysis. PLoS One. 2014;9:e111247 (level 1).

  8. Simpson SH, Gamble JM, Mereu L, et al. Effect of aspirin dose on mortality and cardiovascular events in people with diabetes: a meta-analysis. J Gen Intern Med. 2011;26:1336–44 (level 2).

  9. Baigent C, Blackwell L, Collins R, et al, Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009;373:1849–60 (level 1+).

13 Diabetes and periodontitis

  1. Takahashi K, Nishimura F, Kurihara M, et al. Subgingival microflora and antibody responses against periodontal bacteria of young Japanese patients with type 1 diabetes mellitus. J Int Acad Periodontol. 2001;3:104–11 (level 3).

  2. Morita I, Inagaki K, Nakamura F, et al. Relationship between periodontal status and levels of glycated hemoglobin. J Dent Res. 2012;91:161–6 (level 3).

  3. Borgnakke WS, Ylöstalo PV, Taylor GW, et al. Effect of periodontal disease on diabetes: systematic review of epidemiologic observational evidence. J Periodontol. 2013;84:S135–52 (level 2).

  4. Katagiri S, Nitta H, Nagasawa T, et al. Effect of glycemic control on periodontitis in type 2 diabetic patients with periodontal disease. J Diabetes Investig. 2013;4:320–5 (level 3).

  5. Demmer RT, Jacobs DR, Desvarieux M. Periodontal disease and incident type 2 diabetes: results from the First National Health and Nutrition Examination Survey and its epidemiologic follow-up study. Diabetes Care. 2008;31:1373–9 (level 2).

  6. Engebretson S, Kocher T. Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol. 2013;84:S153–69 (level 1).

14 Diabetes complicated by obesity (including metabolic syndrome)

  1. Matsuzawa Y, Sakata T, Ikeda Y, et al: Guidelines for the management of obesity disease 2006. 2006:1–91 (in Japanese).

  2. Saito Y, Shirai A, Nakamura M, et al: Diagnostic criteria for obesity disease 2011. 2011:1–78 (in Japanese).

  3. Van Gaal L, Scheen A. Weight management in type 2 diabetes: current and emerging approaches to treatment. Diabetes Care. 2015;38:1161–72.

  4. Madigan CD, Aveyard P, Jolly K, et al. Regular self-weighing to promote weight maintenance after intentional weight loss: a quasi-randomized controlled trail. J Public Health (Oxf). 2014;36:259–67 (level 2).

  5. Ribaric G, Buchwald JN, McGlennon TW. Diabetes and weight in comparative studies of bariatric surgery vs conventional medical therapy: a systematic review and meta-analysis. Obes Surg. 2014;24:437–55 (level 2).

  6. Committee on Diagnostic Criteria for Metabolic Syndrome. Metabolic syndrome: its definition and diagnostic criteria. J Jpn Soc Intern. 2005;94:794–9 (in Japanese).

15 Hypertension associated with diabetes

  1. Kengne AP, Patel A, Barzi F, et al, Asia Pacific Cohort Studies Collaboration. Systolic blood pressure, diabetes and the risk of cardiovascular diseases in the Asia-Pacific region. J Hypertens. 2007;25:205–13 (level 2).

  2. Patel A, MacMahon S, Chalmers J, et al. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007;370:829–40 (level 1+).

  3. American Diabetes Association. Microvascular complications and foot care: standards of medical care in diabetes 2016. Diabetes Care. 2016;39:S72–80.

  4. American Diabetes Association. Standards of medical care in diabetes 2010. Diabetes Care. 2010;30:S4–10.

  5. Bangalore S, Kumar S, Lobach I, et al. Blood pressure targets in subjects with type 2 diabetes mellitus/impaired fasting glucose: observations from traditional and bayesian random-effects meta analyses of randomized trials. Circulation. 2011;123:2799–810 (level 1).

  6. Eguchi K, Hoshide S, Ishikawa S, et al. Aggressive blood pressure-lowering therapy guided by home blood pressure monitoring improves target organ damage in hypertensive patients with type 2 diabetes/prediabetes. J Clin Hypertens. 2012;14:422–8 (level 3).

  7. Cooper-DeHoff RM, Gong Y, Handberg EM, et al. Tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease. JAMA. 2010;304:61–8 (level 3).

  8. Haller H, Ito S, Izzo JL Jr, et al. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011;364:907–17 (level 1+).

  9. Heart Outcomes Prevention Evaluation Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet. 2000;355:253–9 (level 1+).

  10. Lewis JB, Berl T, Bain RP, et al. Effect of intensive blood pressure control on the course of type 1 diabetic nephropathy: Collaborative Study Group. Am J Kidney Dis. 1999;34:809–17 (level 1).

16 Dyslipidemia associated with diabetes

  1. Wang Y, Lammi-Keefe CJ, Hou L, et al. Impact of low-density lipoprotein cholesterol on cardiovascular outcomes in people with type 2 diabetes: a meta-analysis of prospective cohort studies. Diabetes Res Clin Pract. 2013;102:65–75 (level 2).

  2. Turner RC, Millns H, Neil HA, et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS 23). BMJ. 1998;316:823–8 (level 3).

  3. Sacks FM, Hermans MP, Fioretto P, et al. Association between plasma triglycerides and high-density lipoprotein cholesterol and microvascular kidney disease and retinopathy in type 2 diabetes mellitus: a global case-control study in 13 countries. Circulation. 2014;129:999–1008 (level 3).

  4. Toth PP, Simko RJ, Palli SR, et al. The impact of serum lipids on risk for microangiopathy in patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2012;11:109–9 (level 3).

  5. Heilbronn LK, Noakes M, Clifton PM. Effect of energy restriction, weight loss, and diet composition on plasma lipids and glucose in patients with type 2 diabetes. Diabetes Care. 1999;22:889–95 (level 1).

  6. Hartweg J, Perera R, Montori V, et al. Omega-3 polyunsaturated fatty acids (PUFA) for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2008:CD003205–CD003205 (level 1).

  7. Hayashino Y, Jackson JL, Fukumori N, et al. Effects of supervised exercise on lipid profiles and blood pressure control in people with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2012;98:349–60 (level 1).

  8. Cholesterol Treatment Trialists C, Kearney PM, Blackwell L, et al. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008;371:117–25 (level 1).

  9. Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364:685–96 (level 1+).

  10. Keech A, Simes RJ, Barter P, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366:1849–61 (level 1+).

  11. Group AS, Ginsberg HN, Elam MB, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010;362:1563–74 (level 1+).

17 Impaired glucose metabolism in pregnancy

  1. Ray JG, O’Brien TE, Chan WS. Preconception care and the risk of congenital anomalies in the offspring of women with diabetes mellitus: a meta-analysis. QJM. 2001;94:435–44 (level 2).

  2. Falavigna M, Schmidt MI, Trujillo J, et al. Effectiveness of gestational diabetes treatment: a systematic review with quality of evidence assessment. Diabetes Res Clin Pract. 2012;98:396–405 (level 2).

  3. Ekbom P, Damm P, Feldt-Rasmussen B, et al. Pregnancy outcome in type 1 diabetic women with microalbuminuria. Diabetes Care. 2001;24:1739–44 (level 2).

  4. Metzger BE, Lowe LP, Dyer AR, HAPO Study Cooperative Research Group, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358:1991–2002 (level 2).

  5. Chew EY, Mills JL, Metzger BE, et al. Metabolic control and progression of retinopathy. The Diabetes in Early Pregnancy Study. National Institute of Child Health and Human Development Diabetes in Early Pregnancy Study. Diabetes Care. 1995;18:631–7 (level 2).

  6. Sanaka M,Minei S,Iwamoto Y. The allowance for pregnancy of women with diabetic nephropathy. J Jpn Soc Diabetes Pregnancy. 2006;6:127–35 (in Japanese, level 4).

  7. Griffin ME, Coffey M, Johnson H, et al. Universal vs. risk factor-based screening for gestational diabetes mellitus: detection rates, gestation at diagnosis and outcome. Diabet Med. 2000;17:26–32 (level 2).

  8. Ludwig DS, Currie J. The association between pregnancy weight gain and birthweight: a within-family comparison. Lancet. 2010;376:984–90 (level 2).

  9. Langer O, Rodriguez DA, Xenakis EM, et al. Intensified versus conventional management of gestational diabetes. Am J Obstet Gynecol. 1994;170:1036–1046 (discussion 1046–1047, level 3).

  10. Bellamy L, Casas JP, Hingorani AD, et al. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009;373:1773–9 (level 1).

  11. 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;58:801–803 (in Japanese)

18 Pediatric/adolescent diabetes

  1. ISPAD Clinical Practice Consensus Guidelines for Pediatric and Adolescent Diabetes 2014. Nankodo, Tokyo. 2015.

  2. Ascerini C, Craig ME, de Beaufort C, et al. ISPAD clinical practice consensus guidelines 2014 compendium. Introduction. Pediatr Diabetes. 2014;15(Suppl 20):1–3.

  3. Craig ME, Jefferies C, Dabelea D, et al. ISPAD clinical practice consensus guidelines 2014 compendium. Definition, epidemiology, and classification of diabetes in children and adlescents. Pediatr Diabetes 2014;15(Suppl 20):4–17.

  4. Ly TT, Maahs DM, Rewers A, et al. ISPAD clinical practice consensus guidelines 2014 compendium. Assessment and management of hypoglycemia in children and adolescents with diabetes. Pediatr Diabetes. 2014;15(Suppl 20):180–92.

  5. Zeitler P, Fu J, Tandon N, et al. ISPAD clinical practice consensus guidelines 2014 compendium. Type 2 diabetes in the child and adolescent. Pediatr Diabetes. 2014;15(Suppl 20):26–46.

  6. Urakami T, Suzuki J, Mugishima H, et al. Screening and treatment of childhood type 1 and type 2 diabetes mellitus in Japan. Pediatr Endocrinol Rev. 2012;10(Supple 1):51–61.

  7. Rubio-Cabezas O, Hattersley AT, Njölstad PR, et al. ISPAD clinical practice consensus guidelines 2014 compendium. The diagnosis and management of monogenic diabetes in children and adolescents. Pediatr Diabetes. 2014;15(Suppl 20):47–64.

  8. Sugihara S, Sasaki N, Kohno H, et al. Survey of current medical treatments for child-onset type 2 diabetes mellitus in Japan. Clin Pediatr Endocrinol. 2005;14:65–75 (level 4).

  9. Rafiq M, Flanagan SE, Patch AM, et al. Effective treatment with oral sulfonylureas in patients with diabetes due to sulfonylurea receptor 1 (SUR1) mutations. Diabetes Care. 2008;31:204–9 (level 3).

  10. Lange K, Swift P, Pankowska E, et al. ISPAD clinical practice consensus guidelines 2014 compendium. Diabetes education. Pediatr Diabetes. 2014;15(Suppl 20):77–85.

  11. Delamater AM, de Wit M, McDarby V, et al. ISPAD clinical practice consensus guidelines 2014 compendium. Psychological issues. Pediatr Diabetes. 2014;15(Suppl 20):232–44.

  12. Winkley K, Landau S, Eisler I, et al. Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomized controlled trials. BMJ. 2006;333:65–8 (level 1).

19 Diabetes in older adults

  1. Ito H. Study to establish a treatment guideline for the elderly patients with diabetes mellitus. In: Research reports of the longevity sciences volume 3. The Ministry of Health and Welfare of Japan. 1996. p. 309–11 (in Japanese, level 3).

  2. Kuusisto J, Mykkänen L, Pyörälä K, et al. NIDDM and its metabolic control predict coronary heart disease in elderly subjects. Diabetes 1994;43:960–7 (level 2).

  3. Cukierman T, Gerstein HC, Williamson JD. Cognitive decline and dementia in diabetes-systematic overview of prospective observational studies. Diabetologia. 2005;48:2460–9 (level 2).

  4. Whitmer RA, Karter AJ, Yaffe K, et al. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA. 2009;301:1565–72 (level 2).

  5. Kalyani RR, Tian J, Xue QL, et al. Hyperglycemia and incidence of frailty and lower extremity mobility limitations in older women. J Am Geriatr Soc. 2012;60:1701–7 (level 2).

  6. Volpato S, Leveille SG, Blaum C, et al. Risk factors for falls in older disabled women with diabetes: the women’s health and aging study. J Gerontol A Biol Sci Med Sci. 2005;60:1539–45 (level 2).

  7. Johnston SS, Conner C, Aagren M, et al. Association between hypoglycaemic events and fall-related fractures in Medicare-covered patients with type 2 diabetes. Diabetes Obes Metab. 2012;14:634–43 (level 3).

  8. Launer LJ, Miller ME, Williamson JD, et al. Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lancet Neurol. 2011;10:969–77 (level 1).

  9. Wannamethee SG, Shaper AG, Walker M. Changes in physical activity, mortality, and incidence of coronary heart disease in older men. Lancet. 1998;351:1603–8 (level 2).

  10. Vita AJ, Terry RB, Hubert HB, et al. Aging, health risks, and cumulative disability. N Eng J Med 1998;338:1035–41 (level 2).

  11. Japanese Geriatrics Society. Methodology for evaluation of cognitive function and diagnosis of dementia—a useful tool for geriatric care (in Japanese). http://www.jpn-geriat-soc.or.jp/tool/index.html.

  12. Methodology for evaluation of ADL. Methodology for evaluation of cognitive function and diagnosis of dementia—a useful tool for geriatric care (in Japanese). http://www.jpn-geriat-soc.or.jp/tool/index.html.

20 Acute metabolic complications of diabetes, sick days, and infectious diseases

  1. Nyenwe EA, Kitabchi AE: Evidence-based management of hyperglycemic emergencies in diabetes mellitus. Diabetes Res Clin Pract. 2011;94:340–51.

  2. Kitabchi AE, Umpierrez GE, Miles JM, et al. Hyperglycemic crises in adult patients with diabetes. Diabetes Care. 2009;32:1335–43.

  3. Wolfsdorf J, Glaser N, Sperling MA. Diabetic ketoacidosis in infants, children, and adolescents. Diabetes Care. 2006;29:1150–9.

  4. Jeffrey A, Kraut MD, Nicolaos E, et al. Lactic acidosis. N Engl J Med. 2014;371:2309–19.

  5. Eppenga WL, Lalmohamed A, Geerts AF, et al. Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: a population-based cohort study. Diabetes Care. 2014;37:2218–24 (level 2).

  6. Silvio E, Inzucchi MD, Kasia J, et al. Metformin in patient with type 2 diabetes and kidney disease. JAMA. 2014;312:2668–75.

  7. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39:S6–104.

  8. Seaquist ER, Anderson J, Childs B, et al. American Diabetes Association: Endocrine Society: hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. J Clin Endocrinol Metab. 2013;98:1845–59.

  9. Nirmal J, Gregory M, Caputo GM, et al. Infections in patients with diabetes mellitus. N Engl J Med. 1999;341:1906–12.

  10. NICE-SUGAR Study Investigators, Finfer S, Chittock DR, et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360:1283–97 (level 1+).

  11. The Japanese society of Intensive Care Medicine Sepsis Registry. The Japanese Guidelines for the Management of Sepsis. 2013 (in Japanese).

  12. Darren L, Dean TE, Sumit RM, et al. Effectiveness of influenza vaccination in working-age adults with diabetes: a population-based cohort study. Thorax. 2013;68:658–63 (level 2).

  13. Moberley SA, Holden J, Tatham DP, et al. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Syst Rev. 2013:CD000422 (level 1).

  14. Brink S, Joel D, Laffel L, et al. Sick day management in children and adolescents with diabetes. Pediatr Diabetes. 2014;15:193–202.

21 Prevention of type 2 diabetes

  1. Heianza Y, Arase Y, Hsieh SD, et al. Development of a new scoring system for predicting the 5 year incidence of type 2 diabetes in Japan: the Toranomon Hospital Health Management Center Study 6 (TOPICS 6). Diabetologia 2012;55:3213–23 (level 3).

  2. Sasai H, Sairenchi T, Irie F, et al. Development of a diabetes risk prediction sheet for specific health guidance. Nippon Koshu Eisei Zasshi. 2008;55:287–94 (in Japanese, level 3).

  3. Doi Y, Ninomiya T, Hata J et al. Two risk score models for predicting incident type 2 diabetes in Japan. Diabet Med. 2012;29:107–114 (level 2).

  4. Kodama S, Horikawa C, Fujihara K, et al. Comparisons of the strength of associations with future type 2 diabetes risk among anthropometric obesity indicators, including waist-to-height ratio: a meta-analysis. Am J Epidemiol. 2012;176:959–69 (level 2).

  5. Kodama S, Horikawa C, Yoshizawa S, et al. Body weight change and type 2 diabetes. Epidemiology. 2013;24:778–9 (level 2).

  6. Kodama S, Horikawa C, Fujihara K, et al. Quantitative relationship between body weight gain in adulthood and incident type 2 diabetes: a meta-analysis. Obes Rev. 2014;15:202–14 (level 2).

  7. . Harder T, Rodekamp E, Schellong K, et al. Birth weight and subsequent risk of type 2 diabetes: a metaanalysis. Am J Epidemiol. 2007;165:849–57 (level 2).

  8. Whincup PH, Kaye SJ, Owen CG, et al. Birth weight and risk of type 2 diabetes: a systematic review. JAMA. 2008;300:2886–97 (level 2).

  9. Sato KK, Hayashi T, Kambe H, et al. Walking to work is an independent predictor of incidence of type 2 diabetes in Japanese men: the Kansai Healthcare Study. Diabetes Care. 2007;30:2296–8 (level 2).

  10. Jeon CY, Lokken RP, Hu FB, et al. Physical activity of moderate intensity and risk of type 2 diabetes: a systematic review. Diabetes Care. 2007;30:744–52 (level 2).

  11. Grontved A, Pan A, Mekary RA, et al. Muscle-strengthening and conditioning activities and risk of type 2 diabetes: a prospective study in two cohorts of US women. PLoS Med. 2014;11:e1001587 (level 2).

  12. Grontved A, Rimm EB, Willett WC, et al. A prospective study of weight training and risk of type 2 diabetes mellitus in men. Arch Intern Med. 2012;172:1306–12 (level 2).

  13. Kosaka K, Noda M, Kuzuya T. Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males. Diabetes Res Clin Pract. 2005;67:152–62 (level 1).

  14. Sakane N, Sato J, Tsushita K, et al. Prevention of type 2 diabetes in a primary healthcare setting: three year results of lifestyle intervention in Japanese subjects with impaired glucose tolerance. BMC Public Health. 2011;11:40 (level 1).

  15. Saito T, Watanabe M, Nishida J, et al. Lifestyle modification and prevention of type 2 diabetes in overweight Japanese with impaired fasting glucose levels: a randomized controlled trial. Arch Intern Med. 2011;171:1352–60 (level 1).

  16. Schulze MB, Schulz M, Heidemann C, et al. Fiber and magnesium intake and incidence of type 2 diabetes: a prospective study and meta-analysis. Arch Intern Med. 2007;167:956–65 (level 2).

  17. Yao B, Fang H, Xu W, et al. Dietary fiber intake and risk of type 2 diabetes: a dose-response analysis of prospective studies. Eur J Epidemiol. 2014;29:79–88 (level 2).

  18. Koppes LL, Dekker JM, Hendriks HF, et al. Moderate alcohol consumption lowers the risk of type 2 diabetes: a meta-analysis of prospective observational studies. Diabetes Care. 2005;28:719–25 (level 2).

  19. Baliunas DO, Taylor BJ, Irving H, et al. Alcohol as a risk factor for type 2 diabetes: a systematic review and meta-analysis. Diabetes Care. 2009;32:2123–32 (level 2).

  20. Waki K, Noda M, Sasaki S, et al. Alcohol consumption and other risk factors for self-reported diabetes among middle-aged Japanese: a population-based prospective study in the JPHC study cohort I. Diabet Med. 2005;22:323–31 (level 2).

  21. Seike N, Noda M, Kadowaki T. Alcohol consumption and risk of type 2 diabetes mellitus in Japanese: a systematic review. Asia Pac J Clin Nutr. 2008;17:545–51.

  22. Ministry of Health, Labor and Welfare. Alcohol. Available from: http://www1.mhlw.go.jp/topics/kenko21_11/b5.html#A51. (in Japanese).

  23. Malik VS, Popkin BM, Bray GA, et al. Sugar-sweetened beverages and risk of metabolic syndrome and type 2 diabetes: a meta-analysis. Diabetes Care. 2010;33:2477–83 (level 2).

  24. Greenwood DC, Threapleton DE, Evans CE, et al. Association between sugar-sweetened and artificially sweetened soft drinks and type 2 diabetes: systematic review and dose-response meta-analysis of prospective studies. 2014;Br J Nutr. 112:725–34 (level 2).

  25. Kato M, Noda M, Inoue M, et al. Psychological factors, coffee and risk of diabetes mellitus among middle-aged Japanese: a population-based prospective study in the JPHC study cohort. Endocr J. 2009;56:459–68 (level 2).

  26. Willi C, Bodenmann P, Ghali WA, et al. Active smoking and the risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2007;298:2654–64 (level 2).

  27. Yeh HC, Duncan BB, Schmidt MI, et al. Smoking, smoking cessation, and risk for type 2 diabetes mellitus: a cohort study. Ann Intern Med. 2010;152:10–17 (level 2).

  28. Oba S, Noda M, Waki K, et al. Smoking cessation increases short-term risk of type 2 diabetes irrespective of weight gain: the Japan Public Health Center-based prospective study. PLoS One. 2012;7:e17061 (level 2).

  29. Mezuk B, Eaton WW, Albrecht S, et al. Depression and type 2 diabetes over the lifespan: a meta-analysis. Diabetes Care. 2008;31 2383–90 (level 2).

  30. Knol MJ, Twisk JW, Beekman AT, et al. Depression as a risk factor for the onset of type 2 diabetes mellitus. A meta-analysis. Diabetologia. 2006;49:837–45 (level 2).

  31. Cappuccio FP, D’Elia L, Strazzullo P, et al. Quantity and quality of sleep and incidence of type 2 diabetes: a systematic review and meta-analysis. Diabetes Care. 2010;33:414–20 (level 2).

  32. Gan Y, Yang C, Tong X, et al. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015;72:72–8 (level 2).

  33. Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374:1677–86 (level 1).

  34. Lindstrom J, Peltonen M, Eriksson JG, et al. Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013;56:284–93 (level 1).

  35. Li G, Zhang P, Wang J et al. Cardiovascular mortality, all-cause mortality, and diabetes incidence after lifestyle intervention for people with impaired glucose tolerance in the Da Qing Diabetes Prevention Study: a 23-year follow-up study. Lancet Diabetes Endocrinol. 2014;2:474–80 (level 1).

  36. 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 (level 1).

  37. Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOPNIDDM randomised trial. Lancet. 2002;359:2072–7 (level 1).

  38. Padwal R, Majumdar SR, Johnson JA, et al. A systematic review of drug therapy to delay or prevent type 2 diabetes. Diabetes Care. 2005;28:736–44 (level 2).

  39. DeFronzo RA, Tripathy D, Schwenke DC, et al. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011;364:1104–15 (level 1).

  40. Kawamori R, Tajima N, Iwamoto Y, et al. Voglibose for prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese individuals with impaired glucose tolerance. Lancet. 2009;373:1607–14 (level 1).

Appendix

  1. Bonovas S, Filioussi K, Tsantes A. Diabetes mellitus and risk of prostate cancer: a meta-analysis. Diabetologia. 2004;47:1071–1078.

  2. Friberg E, Orsini N, Mantzoros CS et al. Diabetes mellitus and risk of endometrial cancer: a meta-analysis. Diabetologia. 2007;50:1365–1374.

  3. Huxley R, Ansary-Moghaddam A, de Gonzalez AB et al. Type-II diabetes and pancreatic cancer: a meta-analysis of 36 studies. Br J Cancer. 2005;92:2076–2083.

  4. Kasper JS, Giovannucci E. A meta-analysis of diabetes mellitus and the risk of prostate cancer. Cancer Epidemiol Biomarkers Prev. 2006;15:2056–2062.

  5. Larsson SC, Orsini N, Wolk A. Diabetes mellitus and risk of colorectal cancer: a meta-analysis. J Natl Cancer Inst. 2005;97:1679–1687.

  6. Larsson SC, Orsini N, Brismar K et al. Diabetes mellitus and risk of bladder cancer: a meta-analysis. Diabetologia. 2006;49:2819–2823.

  7. Larsson SC, Mantzoros CS, Wolk A. Diabetes mellitus and risk of breast cancer: a meta-analysis. Int J Cancer. 2007;121:856–862.

  8. Noto H, Osame K, Sasazuki T, Noda M. Substantially increased risk of cancer in patients with diabetes mellitus: a systematic review and meta-analysis of epidemiologic evidence in Japan. J Diabetes Complications. 2010;24:345–353.

  9. Noto H, Tsujimoto T, Sasazuki T et al. Significantly increased risk of cancer in patients with diabetes mellitus: a systematic review and meta-analysis. Endocr Pract. 2011;17:616–628.

  10. Kasuga M, Ueki K, Tajima N et al. Report of the JDS/JCA Joint Committee on Diabetes and Cancer. Diabetol Int 2013; 2:81–96.

  11. Sasazuki S, Charvat H, Hara A et al. Diabetes mellitus and cancer risk: pooled analysis of eight cohort studies in Japan. Cancer Sci. 2013;104:1499–1507.

  12. Loke YK, Singh S, Furberg CD. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ. 2009;180:32–39.

  13. Ad hoc committee for Japanese 2015 guidelines for prevention and treatment of osteoporosis, Chairman Hajime Orim. Japanese 2015 guidelines for prevention and treatment of osteoporosis. Life Science Publishing Co., Ltd.; 2015. (in Japanese)

  14. FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density. http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm/. Accessed 28 Feb 2018.

  15. Keegan TH, Schwartz AV, Bauer DC et al. Effect of alendronate on bone mineral density and biochemical markers of bone turnover in type 2 diabetic women: the fracture intervention trial. Diabetes Care. 2004;27:1547–1553.

  16. Kenmochi T, Asano T, Saigo K et al. The first case of simultaneous pancreas-kidney transplant from living donor in our country. Japanese J. of Transplant. 2005;40:466–472. (in Japanese)

  17. Fukao K, Otsuka M, Iwasaki H et al. A case of simultaneous whole pancreas and kidney allotransplantation. Japanese J. of Transplant. 1986;21:331–340. (in Japanese)

  18. Saito T, Gotoh M, Satomi S et al. Islet transplantation using donors after cardiac death: report of the Japan Islet Transplantation Registry. Transplantation. 2010;90:740–747.

  19. The Japanese Pancreas and Islet Transplantation Association. Islet transplantation in Japan―Report from Japanese Islet Transplantation Registry―. Japanese J. of Transplant. 2014;49:292–297. (in Japanese).

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Masakazu Haneda.

Additional information

This article is based on the "Japanese Clinical Practice Guideline for Diabetes 2016" (ISBN978-4-524-25857-4), which was published in Japanese by Nankodo Co., Ltd. (© The Japan Diabetes Society (JDS), 2016) and has been jointly published in Journal of Diabetes Investigation (the official journal of the Asian Association for the Study of Diabetes: https://doi.org/10.1111/jdi.12810) and Diabetology International (the official English journal of JDS).

Appendix

Appendix

① Diabetes and cancer

  1. 1.

    Report of the JDS/JCA Committee on Diabetes and Cancer

Given that there is a clear association between diabetes and the risk of cancer [1–9], experts from the Japan Diabetes Society (JDS) and the Japanese Cancer Association (JCA) launched a Joint Committee on Diabetes and Cancer, published a report in 2013 and provided its recommendations for physicians and other healthcare providers as well as for the general public, including patients [10].

  1. 2.

    The Cancer Risk in Patients with Diabetes

A pooled analysis of eight cohort studies conducted in Japan reported that the hazard ratio (HR) for the total cancer risk among patients with diabetes was 1.19 in comparison to those without, with the HR among men being 1.19 [95% confidence interval (CI) 1.12–1.25] and that among women being 1.19 (95% CI, 1.12–1.27) [11]. The mechanisms through which diabetes is likely to promote oncogenesis include insulin resistance and associated hyperinsulinemia, hyperglycemia, and chronic inflammation. However, whether diabetes is a causal risk factor for cancer remains to be elucidated.

  1. 3.

    Glucose-lowering agents and cancer risk

At present, the association between glucose-lowering agents and the cancer risk remains to be fully clarified. Thus, it is thought to be preferable that priority be given to maximizing the benefits of favorable glycemic control with these agents, with due consideration given to the warnings contained in their package inserts.

② Diabetes and bone mineral metabolism

  1. 1.

    The risk of bone fracture in patients with diabetes

The relative risk of proximal femoral fracture is increased three- to sevenfold in patients with type 1 diabetes and 1.3- to 2.8-fold in patients with type 2 diabetes.

Bone strength consists of two factors: bone mineral density (BMD) and bone quality.

The bone mineral metabolism in type 2 diabetes is characterized by increased BMD and impaired bone quality.

  1. 2.

    Anti-diabetic agents and bone mineral metabolism

A meta-analysis demonstrated that thiazolidinedione (TZD) treatment was associated with a 1.45-fold increase in the risk of fracture [12]. A further analysis indicated that TZDs were associated with a 2.23-fold increase in the risk of fracture in women but not in men [13].

There is no consensus on the risk of fracture associated with the use of insulin, DPP-4 inhibitors, GLP-1 receptor agonists, or metformin.

The US Food and Drug Administration (FDA) reported in its Drug Safety Communication that an SGLT-2 inhibitor, canagliflozin, has been associated with decreased BMD and an increased risk of fracture in comparison to a placebo [14].

  1. 3.

    The use of anti-osteoporosis agents in diabetes

The lumbar and femoral neck BMD have been reported to increase in patients with type 2 diabetes who receive alendronate [15].

③ Pancreas/islet transplantation

  1. 1.

    Pancreas transplantation

Pancreas transplantation has become available as a radical therapy for severe diabetes, particularly type 1 diabetes.

Pancreas transplantation is broadly divided into simultaneous pancreas and kidney transplantation (SPK), pancreas-after-kidney transplantation (PAK), and pancreas transplantation alone (PTA). SPK accounts for > 80% of all pancreas transplants performed in Japan and the rest of the world.

Data from the 210 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 95.8%, with the 5-year pancreas and kidney survival rates of 70.4 and 89.2%, respectively.

The first living donor pancreas transplant in Japan was performed in January 2004 [16]; and as of the end of 2014, a total of 27 transplants had been performed.

  1. 2.

    Islet transplantation

Islet transplantation is a form of tissue transplantation that involves the injection of islets isolated from donor(s) into the recipient’s portal vein and is thus less invasive than pancreas transplantation.

In Japan, 34 islet transplantation procedures (from non-heart beating donors) were performed in 18 patients (male, n = 5; female, n = 13) between 2004 and 2007; the procedures were performed in accordance with the Edmonton protocol [17]. Among these patients, 8, 4 and 6 patients received one, two and three transplants, respectively. One of the patients who received two transplants and two who received three transplants were shown to have achieved a temporary withdrawal of insulin therapy [18, 19].

The 1-, 2- and 3-year graft survival rates in these patients were 72.2, 44.4, and 22.2%, respectively. The 1-year graft survival rate among those who received multiple transplants was 100% [18, 19].

④ J-DOIT 1, 2, and 3, JDCP study and J-DREAMS

  • On the “Strategic Research Projects for Prevention of Diabetes”

In 2005, the Ministry of Health, Labor and Welfare (MHLW) of Japan launched a framework for the Health Frontier Strategic Plan as a large-scale MHLW research project. Thus, as a part of the project, the Strategic Research Projects for Prevention of Diabetes was initiated, consisting of three research themes (J-DOIT 1, 2, and 3, respectively).

  • J-DOIT 1 (Japan Diabetes Outcome Intervention Trial 1)

To prove that intensive lifestyle intervention is effective in preventing the onset of diabetes in patients at high-risk of developing diabetes in real-world settings (i.e., facilities offering health check-ups and health instruction services), a cluster randomized trial entitled, the “Japan Diabetes Outcome Intervention Trial 1 (J-DOIT 1)”, was conducted between March 2007 and March 2012.

  • J-DOIT 2 (Japan Diabetes Outcome Intervention Trial 2)

The “Japan Diabetes Outcome Intervention Trial 2 (J-DOIT 2)” was an interventional study intended to address how best decrease treatment and 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 seek treatment/consultation, providing healthcare instructions, and providing their family physicians with assistance in their treatment/consultations. The results of the study demonstrated that treatment/consultation interruptions had been decreased by 63%, suggesting that the interventional measures were significantly effective in decreasing treatment/consultation interruptions.

  • J-DOIT 3 (the Japan Diabetes Optimal Integrated Treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT 3)

The J-DOIT3 [Japan Diabetes Optimal Integrated Treatment study of three major risk factors for cardiovascular diseases (J-DOIT 3)] aimed to investigate whether or not integrated tight glycemic control, blood pressure control and lipid control may reduce the onset of macroangiopathy among patients with type 2 diabetes.

J-DOIT 3 was conducted from 2006 until March 2016. The study involved a total of 81 sites nationwide and enrolled a total of 2,532 type 2 diabetes patients who were considered to have a high-risk of developing macroangiopathy. The patients were randomly allocated to receive intensive therapy or conventional therapy.

  • JDCP study

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 that patients with type 1 and 2 diabetes develop during follow-up.

The JDCP study enrolled a total of 6,338 patients of 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.

  • J-DREAMS

The Japan Diabetes comprehensive database project based on an advanced electronic medical record system (J-DREAMS) is a large-scale database project that was launched by the Japan Diabetes Society (JDS) and the National Center for Global Health and Medicine (NCGM).

Given that all JDS-qualified educational facilities for certificated diabetologists are participating and that hundreds of thousands of patients are expected to be registered, this study will be expected to show the control status of each parameter, the frequency of complications, and the correlations between complications and the glycemic control status or therapeutic agents in patients treated by certified diabetologists.

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Haneda, M., Noda, M., Origasa, H. et al. Japanese Clinical Practice Guideline for Diabetes 2016. Diabetol Int 9, 1–45 (2018). https://doi.org/10.1007/s13340-018-0345-3

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13340-018-0345-3

Keywords

Navigation