Nội dung

S I GN Scottish Intercollegiate Guidelines Network Part of NHS Quality Improvement Scotland 116 Management of diabetes A national clinical guideline March 2010 KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS LEVELS OF EVIDENCE 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias High quality systematic reviews of case control or cohort studies 2++ High  quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-  ase control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not C causal 3 Non-analytic studies, eg case reports, case series 4 Expert opinion GRADES OF RECOMMENDATION Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A B  t least one meta-analysis, systematic review, or RCT rated as 1++, A and directly applicable to the target population; or  body of evidence consisting principally of studies rated as 1+, A directly applicable to the target population, and demonstrating overall consistency of results A body of evidence including studies rated as 2++, d  irectly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ GOOD PRACTICE POINTS  Recommended best practice based on the clinical experience of the guideline development group NHS Quality Improvement Scotland (NHS QIS) is committed to equality and diversity and assesses all its publications for likely impact on the six equality groups defined by age, disability, gender, race, religion/belief and sexual orientation. SIGN guidelines are produced using a standard methodology that has been equality impact assessed to ensure that these equality aims are addressed in every guideline. This methodology is set out in the current version of SIGN 50, our guideline manual, which can be found at www.sign.ac.uk/guidelines/fulltext/50/index.html. The EQIA assessment of the manual can be seen at www.sign.ac.uk/pdf/sign50eqia.pdf. The full report in paper form and/or alternative format is available on request from the NHS QIS Equality and Diversity Officer. Every care is taken to ensure that this publication is correct in every detail at the time of publication. However, in the event of errors or omissions corrections will be published in the web version of this document, which is the definitive version at all times. This version can be found on our web site www.sign.ac.uk. This document is produced from elemental chlorine-free material and is sourced from sustainable forests. Scottish Intercollegiate Guidelines Network Management of diabetes A national clinical guideline March 2010 Management of diabetes ISBN 978 1 905813 58 2 Published March 2010 SIGN consents to the photocopying of this guideline for the purpose of implementation in NHSScotland Scottish Intercollegiate Guidelines Network Elliott House, 8-10 Hillside Crescent Edinburgh EH7 5EA www.sign.ac.uk CONTENTS Contents 1 Introduction................................................................................................................. 1.1 The need for a guideline............................................................................................... 1 1.2 Remit of the guideline................................................................................................... 1 1.3 Definitions.................................................................................................................... 2 1.4 Statement of intent........................................................................................................ 3 2 Key recommendations.................................................................................................. 5 2.1 Lifestyle management.................................................................................................... 5 2.2 Psychosocial factors...................................................................................................... 5 2.3 Management of type 1 diabetes..................................................................................... 6 2.4 Pharmacological management of glycaemic control in people with type 2 diabetes...... 6 2.5 Management of diabetes in pregnancy.......................................................................... 7 2.6 Management of diabetic cardiovascular disease............................................................ 7 2.7 Management of kidney disease in diabetes.................................................................... 7 2.8 Prevention of visual impairment.................................................................................... 8 2.9 Management of diabetic foot disease............................................................................. 8 3 Lifestyle management................................................................................................... 9 3.1 Delivery of lifestyle interventions.................................................................................. 9 3.2 Structured education..................................................................................................... 10 3.3 Self monitoring of glycaemia......................................................................................... 12 3.4 Smoking cessation......................................................................................................... 16 3.5 Exercise and physical activity........................................................................................ 17 3.6 Weight management in type 2 diabetes......................................................................... 20 3.7 Healthy eating............................................................................................................... 22 3.8 Alcohol......................................................................................................................... 23 3.9 Checklist for provision of information........................................................................... 24 4 Psychosocial factors..................................................................................................... 25 4.1 The influence of psychosocial factors on diabetes control............................................. 25 4.2 Screening for psychological distress.............................................................................. 26 4.3 The effect of psychological interventions on diabetes outcomes.................................... 27 4.4 Treatment of psychological distress............................................................................... 28 4.5 Checklist for provision of information........................................................................... 29 1 Management of diabetes 5 Management of type 1 diabetes.................................................................................... 30 5.1 Diagnosis and epidemiology......................................................................................... 30 5.2 Initiating therapy at diagnosis........................................................................................ 30 5.3 Continuing management............................................................................................... 31 5.4 Quality of life................................................................................................................ 36 5.5 Long term complications and screening........................................................................ 37 5.6 Checklist for provision of information........................................................................... 38 6 Pharmacological management of glycaemic control in people with type 2 diabetes.... 39 6.1 Introduction.................................................................................................................. 39 6.2 Targets for glycaemic control........................................................................................ 39 6.3 Metformin..................................................................................................................... 41 6.4 Sulphonylureas............................................................................................................. 42 6.5 Thiazolidinediones........................................................................................................ 44 6.6 Dipeptidyl peptidase-4 inhibitors.................................................................................. 46 6.7 Alpha-glucosidase inhibitors......................................................................................... 47 6.8 Meglitinides.................................................................................................................. 48 6.9 Glucagon like peptide-1 agonists.................................................................................. 48 6.10 Insulin........................................................................................................................... 50 6.11 Algorithm for glucose-lowering in people with type 2 diabetes..................................... 53 6.12 Checklist for provision of information........................................................................... 54 7 Management of diabetes in pregnancy......................................................................... 56 7.1 Introduction.................................................................................................................. 56 7.2 Contraception............................................................................................................... 56 7.3 Pre-pregnancy care........................................................................................................ 57 7.4 Nutritional management............................................................................................... 59 7.5 Optimisation of glycaemic control................................................................................ 59 7.6 Complications during pregnancy................................................................................... 60 7.7 Fetal assessment............................................................................................................ 62 7.8 Gestational diabetes...................................................................................................... 63 7.9 Delivery........................................................................................................................ 66 7.10 Infants of mothers with diabetes.................................................................................... 66 7.11 Postnatal care................................................................................................................ 67 7.12 Follow up of women with GDM................................................................................... 68 7.13 Checklist for provision of information........................................................................... 68 CONTENTS 8 Management of diabetic cardiovascular disease........................................................... 70 8.1 Epidemiology................................................................................................................ 70 8.2 Cardiovascular risk factors............................................................................................. 70 8.3 Primary prevention of coronary heart disease................................................................ 71 8.4 Management of patients with diabetes and acute coronary syndromes.......................... 73 8.5 Management of patients with diabetes and heart failure................................................ 76 8.6 Management of patients with diabetes and stable angina............................................... 79 8.7 Management of acute stroke.......................................................................................... 81 8.8 Peripheral arterial disease.............................................................................................. 81 8.9 Checklist for provision of information........................................................................... 81 9 Management of kidney disease in diabetes................................................................... 83 9.1 Definitions.................................................................................................................... 83 9.2 Prevalence and progression of kidney disease in diabetes............................................. 84 9.3 Screening for kidney disease in diabetes....................................................................... 85 9.4 Investigation of kidney disease in diabetes.................................................................... 87 9.5 Prevention and treatment of kidney disease in diabetes................................................. 87 9.6 Management of complications...................................................................................... 93 9.7 Models of care.............................................................................................................. 94 9.8 Checklist for provision of information........................................................................... 95 10 Prevention of visual impairment................................................................................... 96 10.1 Risk identification and prevention................................................................................. 96 10.2 Screening...................................................................................................................... 97 10.3 Treatment...................................................................................................................... 100 10.4 Rehabilitation................................................................................................................ 102 10.5 Checklist for provision of information........................................................................... 102 11 Management of diabetic foot disease........................................................................... 104 11.1 Epidemiology and risk factors........................................................................................ 104 11.2 Risk stratification........................................................................................................... 104 11.3 Patient education.......................................................................................................... 106 11.4 Preventative footwear and orthoses............................................................................... 106 11.5 Management of active foot disease................................................................................ 107 11.6 Painful diabetic neuropathy........................................................................................... 109 11.7 Checklist for provision of information........................................................................... 110 Management of diabetes 12 Provision of information............................................................................................... 111 12.1 Sources of further information....................................................................................... 111 13 Implementing the guideline.......................................................................................... 112 13.1 Resource implications of key recommendations............................................................ 112 13.2 Auditing current practice............................................................................................... 113 13.3 Additional advice to NHSScotland from NHS Quality Improvement Scotland and the Scottish Medicines Consortium......................................................................... 115 14 The evidence base........................................................................................................ 116 14.1 Systematic literature review........................................................................................... 116 14.2 Recommendations for research..................................................................................... 116 14.3 Review and updating.................................................................................................... 118 15 Development of the guideline...................................................................................... 119 15.1 Introduction.................................................................................................................. 119 15.2 The guideline development group................................................................................. 119 15.3 The guideline steering group......................................................................................... 122 15.4 Consultation and peer review........................................................................................ 123 Abbreviations............................................................................................................................... 125 Annexes ..................................................................................................................................... 130 References................................................................................................................................... 144 1 INTRODUCTION 1 Introduction 1.1 the need for a guideline Diabetes mellitus is a major cause of morbidity and mortality in Scotland and worldwide, with an increasing prevalence. In 2009 there were around 228,000 people registered as having diabetes in Scotland, an increase of 3.6% from the preceding year.1 This increase relates, in part, to the increasing age of the population, an increase in obesity and also perhaps to increasing survival of those with diabetes. Twenty years ago the St Vincent declaration aimed to decrease blindness, end-stage renal failure, amputation and cardiovascular disease in those with diabetes and to improve the outcome of pregnant mothers who have diabetes. Since that time there has been a great increase in evidence showing that many diabetic outcomes can be influenced by appropriate therapies. Part of this evidence base was reviewed in the previous SIGN guideline on management of diabetes (SIGN 55) published in 2001.2 New clinical evidence has been published since then and has resulted in the need for this selective update. Implementing the evidence described in this guideline will have a positive effect on the health of people with diabetes. 1.1.1 updating the evidence Since the publication of SIGN 55, new evidence has been published in many areas covered by the recommendations in that guideline. Where this evidence was thought likely to significantly change either the content or grading of these recommendations, it has been identified and reviewed. Where new evidence does not update existing recommendations and where no new evidence was identified to support an update, the guideline text and recommendations are reproduced verbatim from SIGN 55. The original supporting evidence was not re-appraised by the current guideline development group. A number of new areas that were not considered in SIGN 55 have also been incorporated into this selective update, including entirely new sections on glucose-lowering agents for people with type 2 diabetes and psychosocial factors (see section 1.2.3). A Cost and Resource Impact Assesment report developed by NHS QIS is available as a companion document to this guideline. This document reports the national costs to NHSScotland of implementing recommendations that are estimated to have a net additional cost of £5 million or more to introduce. 1.2 REMIT of the guideline 1.2.1 overall objectives This guideline provides recommendations based on current evidence for best practice in the management of diabetes. For people with type 1 and type 2 diabetes recommendations for lifestyle interventions are included, as are recommendations for the management of cardiovascular, kidney and foot diseases. Guidance for all people with diabetes to prevent visual impairment, and specific advice for pregnant women with diabetes is provided. A new section on the management of psychosocial issues, drawn partially from evidence originally contained in other sections, is now included. Finally, a section on the management of type 1 diabetes and a new section on glucose-lowering therapies in people with type 2 diabetes have been added. Implementation of these recommendations will encourage the provision and development of high quality care for people with diabetes. It should also inform the development of measureable standards of diabetes care. Prevention of diabetes and pre-diabetes are not covered. 1 Management of diabetes 1.2.2 target users of the guideline This guideline will mainly be of interest to all healthcare professionals involved in the care of people with diabetes. The target users are, however, much broader than this, and include people with diabetes, their carers and those who interact with people with diabetes outside of the NHS. It will also be of interest to those planning the delivery of services in NHSScotland and beyond. 1.2.3 summary of updates to the guideline, by section 1.3 2 Key recommendations New 3 Lifestyle management Updated 4 Psychosocial factors Updated 5 Management of type 1 diabetes Updated 6 Pharmacological management of glycaemic control in people with New type 2 diabetes 7 Management of diabetes in pregnancy Updated 8 Management of diabetic cardiovascular disease Updated 9 Management of kidney disease in diabetes Updated 10 Prevention of visual impairment Updated 11 Management of diabetic foot disease Minor update 12 Provision of information New definitions Diabetes mellitus is defined as a metabolic disorder of multiple aetiology characterised by chronic hyperglycaemia with disturbances of carbohydrate, protein and fat metabolism resulting from defects in insulin secretion, insulin action, or both. The clinical diagnosis of diabetes is often indicated by the presence of symptoms such as polyuria, polydipsia, and unexplained weight loss, and is confirmed by measurement of abnormal hyperglycaemia.3 The World Health Organization (WHO)3 advises that the range of blood glucose indicative of diabetes mellitus is as follows: ƒƒ fasting venous plasma glucose (FPG) ≥7.0 mmol/l; or ƒƒ venous plasma glucose ≥11.1 mmol/l at two hours after a 75 g oral glucose load (oral glucose tolerance test (OGTT)). The fact that glycated haemoglobin (HbA1c) reflects average plasma glucose over the previous two to three months in a single measure which can be performed at any time of the day and does not require any special preparation such as fasting has made it a key measure for assessing glycaemic control in people with established diabetes. In 2006 the WHO considered HbA1c as a candidate diagnostic tool for diabetes. They reported that HbA1c measurement is not widely available in many countries throughout the world and there are aspects of its measurement which are problematic.3 The HbA1c result is influenced by several factors including anaemia, abnormalities of haemoglobin, pregnancy and uraemia. Some of these factors may be a bigger problem in under-resourced countries due to a higher prevalence of anaemia and of haemoglobinopathies. At the time of publication HbA1c was not recommended as a diagnostic test for diabetes, but there is ongoing work to standardise HbA1c reporting worldwide which may lead to further developments in the role of HbA1c. *Impaired Glucose Tolerance (IGT) is a stage of impaired glucose regulation (FPG <7.0 mmol/l and OGTT 2 hour value ≥ 7.8 mmol/l but <11.1mmol/l). Impaired Fasting Glucose (IFG) has been introduced to classify individuals who have fasting glucose values above the normal range but below those diagnostic of diabetes. (fasting plasma glucose ≥ 6.1 mmol/l but <7.0 mmol/l). IGT and IFG are not clinical entities in their own right, but rather risk categories for cardiovascular disease and/or future diabetes. 2