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Guideline Summary
Guideline Title
Management of diabetes. A national clinical guideline.
Bibliographic Source(s)
Scottish Intercollegiate Guidelines Network (SIGN). Management of diabetes. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2010 Mar. 170 p. (SIGN publication; no. 116).  [759 references]
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Scottish Intercollegiate Guidelines Network (SIGN). Management of diabetes. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2001 Nov. 50 p. (SIGN publication; no. 55). [388 references]

Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network Web site External Web Site Policy.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

Drug Withdrawal

  • October 8, 2010 – Meridia (sibutramine) External Web Site Policy: Abbott Laboratories and the U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke. Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

Scope

Disease/Condition(s)
  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • Gestational diabetes
  • Complications of diabetes mellitus, including diabetic cardiovascular disease, kidney disease, visual impairment, and diabetic foot disease
Guideline Category
Management
Risk Assessment
Screening
Treatment
Clinical Specialty
Cardiology
Endocrinology
Family Practice
Internal Medicine
Nephrology
Nursing
Obstetrics and Gynecology
Ophthalmology
Pediatrics
Podiatry
Preventive Medicine
Psychiatry
Psychology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Dietitians
Nurses
Pharmacists
Physician Assistants
Physicians
Podiatrists
Psychologists/Non-physician Behavioral Health Clinicians
Guideline Objective(s)

To provide recommendations based on current evidence for best practice in the management of diabetes including:

  • Lifestyle interventions and the management of cardiovascular, kidney, and foot diseases for people with type 1 and type 2 diabetes
  • Prevention of visual impairment
  • Specific advice for pregnant women with diabetes
  • Management of psychosocial issues
  • Management of type 1 diabetes and glucose-lowering therapies in people with type 2 diabetes
Target Population
  • Children and adults with diabetes mellitus, type 1 or type 2
  • Pregnant women with gestational diabetes
Interventions and Practices Considered

Diagnosis/Evaluation

  1. Screening for pre-type 1 diabetes in general population or high risk children and young people (considered, but not recommended)
  2. Screening for gestational diabetes
  3. Screening for long term complications of diabetes including: foot screening, diabetic kidney disease (urinary albumin/creatinine ratio [ACR]), retinal disease (retinal photography, slit lamp biomicroscopy, dilated direct ophthalmoscopy)
  4. Screening for psychological distress

Management/Treatment

  1. Lifestyle Management
    • Delivery of lifestyle interventions based on valid theoretical framework and multidisciplinary lifestyle intervention programmes
    • Structured education
    • Self-monitoring of glycaemia
    • Smoking cessation
    • Exercise and physical activity
    • Dietary interventions and weight control
    • Use of alcohol
  2. Psychosocial Factors
    • Behaviour modification
    • Motivational interviewing (MotI)
    • Cognitive behavioural therapy (CBT)
    • Acceptance and commitment therapy (ACT)
    • Goal setting
    • Guided self-determination (GSD)
    • Coping skills
  3. Type 1 Diabetes
    • Home-based programme
    • Insulin therapy (rapid-acting and basal insulin analogues, regular human insulin, and neutral protamine Hagedorn [NPH] preparations)
    • Continuous subcutaneous insulin infusion
    • Avoid severe hypoglycaemia
  4. Type 2 Diabetes
    • Metformin
    • Sulphonylureas
    • Thiazolidinediones (pioglitazone, rosiglitazone)
    • Dipeptidyl peptidase-4 inhibitors
    • Alpha-glucosidase inhibitors
    • Meglitinides
    • Glucagon like peptide-1 agonists
    • Insulin therapy (rapid-acting, basal, prandial, and pre-mixed insulin analogues; regular human insulin; and neutral protamine Hagedorn [NPH] preparations)
  5. Diabetes in Pregnancy
    • Pre-pregnancy care provided by a multidisciplinary team
    • Oral medications including folic acid, metformin, and sulphonylureas (glibenclamide only) (Note: statins, sulphonylureas, angiotensin converting enzyme [ACE] inhibitors were considered, but not recommended)
    • Nutritional management
    • Glucose monitoring
    • Insulin therapy/rapid-acting insulin analogues
    • Management of complications
    • Fetal assessment
    • Screening for and management of gestational diabetes including dietary advice, blood glucose monitoring, and glucose-lowering therapy [metformin or glibenclamide]
    • Breastfeeding support
    • Postnatal care and follow-up
  6. Diabetic Cardiovascular Disease
    • Lifestyle modification
    • Pharmacological therapy including glucose-lowering therapy, antihypertensive therapy, and lipid-lowering therapy
    • Glycaemia control
    • Primary percutaneous coronary intervention
    • Thrombolytic therapy after myocardial infarction
    • Antiplatelet therapy (e.g., clopidogrel and aspirin)
    • Beta-blocker therapy
    • ACE inhibitor therapy
    • Fibrate therapy
    • Coronary revascularization procedures
  7. Diabetic Kidney Disease
    • Maintenance of good glycemic control and tight blood pressure control
    • Angiotensin-converting enzyme inhibitor and angiotensin-II receptor blocker therapy
    • Reduction in dietary protein
    • Multifactorial interventions for diabetics with microalbuminuria
    • Management of complications
  8. Prevention of Visual Impairment
    • Risk factor modification
    • Screening for retinal disease (retinal photography, slit lamp biomicroscopy, dilated direct ophthalmoscopy)
    • Laser photocoagulation treatment
    • Vitrectomy
    • Cataract extraction in diabetes
    • Rehabilitation in diabetic eye disease
  9. Diabetic Foot Disease
    • Patient education in foot care
    • Preventive footwear and orthoses
    • Management of active foot disease including referral to a multidisciplinary diabetic foot care service, total casting, prefabricated walkers, negative pressure wound therapy, arterial reconstruction, and assessment and treatment for Charcot neuroarthropathy
    • Pharmacological treatment including antidepressants, including tricyclics, duloxetine and venlafaxine; anticonvulsants, including pregabalin and gabapentin; and opiate analgesia in combination with gabapentin
Major Outcomes Considered
  • Prevalence of diabetes and diabetes-related complications
  • Efficacy of secondary prevention strategies, management strategies, and treatments on factors, such as glycemic control, quality of life, health outcomes and rates of diabetic related complications (i.e., psychological, metabolic, microvascular, cardiovascular, and pregnancy outcomes)

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Systematic Literature Review

The evidence base for this guideline was synthesised in accordance with Scottish Intercollegiate Guidelines Network (SIGN) methodology. A systematic review of the literature was carried out using an explicit search strategy devised by a SIGN Information Officer. Databases searched include Medline, Embase, Cinahl, PsycINFO and the Cochrane Library. The year range covered was 2003-2009. Internet searches were carried out on various websites including the United States (US) National Guideline Clearinghouse. The main searches were supplemented by material identified by individual members of the development group. Each of the selected papers was evaluated by two members of the group using standard SIGN methodological checklists before conclusions were considered as evidence.

Literature Search for Patient Issues

At the start of the guideline development process, a SIGN Information Officer conducted a literature search for qualitative and quantitative studies that addressed patient issues of relevance to management of patients with diabetes. Databases searched include Medline, Embase, Cinahl and PsycINFO, and the results were summarised and presented to the guideline development group. A copy of the Medline version of the patient search strategy is available on the SIGN website.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of randomized controlled trials (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

2++: High quality systematic reviews of case control or cohort studies

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-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies, e.g., case reports, case series

4: Expert opinion

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports.

The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigour and practicality of use.

The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion - e.g., an acceptable level of loss to follow up - and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimise any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment.

Evidence Tables

Evidence tables are compiled by SIGN Executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent.

Additional details can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site External Web Site Policy.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Synthesising the Evidence

Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable.

It is important to emphasise that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved.

Considered Judgment

It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, the Scottish Intercollegiate Guidelines Network (SIGN) has introduced the concept of considered judgment.

Under the heading of considered judgment, guideline development groups summarise their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects:

  • Quantity, quality, and consistency of evidence
  • External validity (generalisability) of study findings
  • Directness of application to the target population for the guideline
  • Any evidence of potential harms associated with implementation of a recommendation
  • Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them in accordance with the recommendation)
  • Whether, and to what extent, any equality groups may be particularly advantaged or disadvantaged by the recommendations made
  • Implementability (i.e., how practical it would be for the National Health Service [NHS] in Scotland to implement the recommendation.)

The groups are finally asked to summarise its view on all of these issues, both the quality of the evidence and its potential impact, before making a graded recommendation. This summary should be succinct, and taken together with its views of the level of evidence represent the first draft of the text that will appear in the guideline immediately before a graded recommendation.

Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site External Web Site Policy.

Rating Scheme for the Strength of the Recommendations

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: At least one meta-analysis, systematic review, or randomised controlled trial (RCT) rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B: 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 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+

Cost Analysis

The guideline developers reviewed published cost analyses.

A cost and resource impact report and an associated spreadsheet have been developed to provide each National Health Service (NHS) board with resource and cost information to support the implementation of the recommendations judged to have a material impact on resources (see Table 7 in the original guideline document). These documents are available from the SIGN website: www.sign.ac.uk External Web Site Policy.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development.

Peer Review

All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to at least two lay reviewers in order to obtain comments from the patient's perspective.

It should be noted that all reviewers are invited to comment as individuals, not as representatives of any particular organisation or group. Corporate interests, whether commercial, professional, or societal have an opportunity to make representations at the national meeting stage where they can send representatives to the meeting or provide comment on the draft produced for that meeting. Peer reviewers are asked to complete a declaration of interests form.

The comments received from peer reviewers and others are carefully tabulated and discussed with the Chair and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded.

As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication.

Recommendations

Major Recommendations

Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.

The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Lifestyle Management

Delivery of Lifestyle Interventions

A - People with diabetes should be offered lifestyle interventions based on a valid theoretical framework.

B - Computer-assisted education packages and telephone prompting should be considered as part of a multidisciplinary lifestyle intervention programme.

B - Healthcare professionals should receive training in patient-centred interventions in diabetes.

Structured Education

A - Adults with type 1 diabetes experiencing problems with hypoglycaemia or who fail to achieve glycaemic targets should have access to structured education programmes based upon adult learning theories.

B - Children and adolescents should have access to programmes of structured education which have a basis in enhancing problem solving skills.

A - Adults with type 2 diabetes should have access to structured education programmes based upon adult learning theories.

Self-Monitoring of Glycaemia

B - Self-monitoring of blood glucose (SMBG) is recommended for patients with type 1 or type 2 diabetes who are using insulin where patients have been educated in appropriate alterations in insulin dose.

B - Routine self-monitoring of blood glucose in people with type 2 diabetes who are using oral glucose-lowering drugs (with the exception of sulphonylureas) is not recommended.

B - Routine self-monitoring of urine glucose is not recommended in patients with type 2 diabetes.

Smoking Cessation

B - All people who smoke should be advised to stop and offered support to help facilitate this in order to minimise cardiovascular and general health risks.

A - Healthcare professionals involved in caring for people with diabetes should advise them not to smoke.

B - Intensive management plus pharmacological therapies should be offered to patients with diabetes who wish to stop smoking.

B - Healthcare professionals should continue to monitor smoking status in all patient groups.

Exercise and Physical Activity

B - All people should be advised to increase their level of physical activity to achieve current physical activity recommendations and be supported to maintain this level across the lifespan.

A - People with type 2 diabetes should be encouraged to participate in physical activity or structured exercise to improve glycaemic control and cardiovascular risk factors.

B - People with type 1 diabetes should be encouraged to participate in physical activity or structured exercise to improve cardiovascular risk factors.

D - Exercise and physical activity (involving aerobic and/or resistance exercise) should be performed on a regular basis.

D - Advice about exercise and physical activity should be individually tailored and diabetes specific and should include implications for glucose management and foot care.

C - Individualised advice on avoiding hypoglycaemia when exercising by adjustment of carbohydrate intake, reduction of insulin dose, and choice of injection site, should be given to patients taking insulin.

D - Patients with existing complications of diabetes should seek medical review before embarking on exercise programmes.

D - A gradual introduction and initial low intensity of physical activity with slow progressions in volume and intensity should be recommended for sedentary people with diabetes.

Weight Management in Type 2 Diabetes

A - Obese adults with type 2 diabetes should be offered individualised interventions to encourage weight loss (including lifestyle, pharmacological or surgical interventions) in order to improve metabolic control.

Healthy Eating

B - People with type 2 diabetes can be given dietary choices for achieving weight loss that may also improve glycaemic control. Options include simple caloric restriction, reducing fat intake, consumption of carbohydrates with low rather than high glycaemic index, and restricting the total amount of dietary carbohydrate (a minimum of 50 g per day appears safe for up to six months).

B - Dietary supplementation with omega-3 polyunsaturated fatty acid (PUFA) is not generally recommended in people with type 2 diabetes.

B - Vitamin E supplementation 500 mg per day is not recommended in people with type 2 diabetes.

B - Overweight individuals and those at high risk of developing diabetes should be encouraged to reduce this risk by lifestyle changes including weight management and physical activity.

B - Clinical interventions aimed at dietary change are more likely to be successful if a psychological approach based on a theoretical model is included.

Alcohol

B - People with diabetes can take alcohol in moderation as part of a healthy lifestyle but should aim to keep within the target consumption recommended for people without diabetes.

Psychosocial Factors

The Influence of Psychosocial Factors on Diabetes Control

B - Regular assessment of a broad range of psychological and behavioural problems in children and adults with type 1 diabetes is recommended.

  • In children this should include eating disorders, behavioural, emotional and family functioning problems.
  • In adults this should include anxiety, depression and eating disorders.

The Effect of Psychological Interventions on Diabetes Outcomes

A - Children and adults with type 1 and type 2 diabetes should be offered psychological interventions (including motivational interviewing, goal setting skills and cognitive behavioural therapy [CBT]) to improve glycaemic control in the short and medium term.

Management of Type 1 Diabetes

Diagnosis and Epidemiology

B - Screening for pre-type 1 diabetes is not recommended in either the general population or in high risk children and young people.

Initiating Therapy at Diagnosis

C - A home-based programme for initial management and education of children with diabetes and their families is an appropriate alternative to a hospital-based programme.

Continuing Management

B - Intensive insulin therapy should be delivered as part of a comprehensive support package.

B - An intensified treatment regimen for adults with type 1 diabetes should include either regular human or rapid-acting insulin analogues.

B - Basal insulin analogues are recommended in adults with type 1 diabetes who are experiencing severe or nocturnal hypoglycaemia and who are using an intensified insulin regimen. Adults with type 1 diabetes who are not experiencing severe or nocturnal hypoglycaemia may use basal analogues or neutral protamine Hagedorm (NPH) insulin.

B - Children and adolescents may use either insulin analogues (rapid-acting and basal), regular human insulin and neutral protamine Hagedorm preparations or an appropriate combination of these.

C - The insulin regimen should be tailored to the individual child to achieve the best possible glycaemic control without disabling hypoglycaemia.

A - Continuous subcutaneous insulin infusion (CSII) therapy is associated with modest improvements in glycaemic control and should be considered for patients unable to achieve their glycaemic targets.

B - CSII therapy should be considered in patients who experience recurring episodes of severe hypoglycaemia.

B - Dietary advice as part of a comprehensive management plan is recommended to improve glycaemic control.

Quality of Life

B - Patients and healthcare professionals should make every effort to avoid severe hypoglycaemia, particularly in those who are newly diagnosed.

Long Term Complications and Screening

A - To reduce the risk of long term microvascular complications, the target for all young people with diabetes is the optimising of glycaemic control towards a normal level.

C - Patients with cystic fibrosis should be screened annually for diabetes from 10 years of age.

C - Young people with diabetes should be screened for thyroid and coeliac disease at onset of diabetes and at intervals throughout their lives.

Pharmacological Management of Glycaemic Control in People with Type 2 Diabetes

Targets for Glycaemic Control

A - A glycosylated haemoglobin (HbA1c) target of 7.0% (53 mmol/mol) among people with type 2 diabetes is reasonable to reduce risk of microvascular disease and macrovascular disease. A target of 6.5% (48 mmol/mol) may be appropriate at diagnosis. Targets should be set for individuals in order to balance benefits with harms, in particular hypoglycaemia and weight gain.

Metformin

A - Metformin should be considered as the first line oral treatment option for overweight patients with type 2 diabetes.

Sulphonylureas

A - Sulphonylureas should be considered as first line oral agents in patients who are not overweight, who are intolerant of, or have contraindications to, metformin.

Thiazolidinediones

Pioglitazone

A - Pioglitazone can be added to metformin and sulphonylurea therapy, or substituted for either in cases of intolerance.

A - Pioglitazone should not be used in patients with heart failure.

B - The risk of fracture should be considered in the long term care of female patients treated with pioglitazone.

Rosiglitazone

A - Rosiglitazone can be added to metformin and sulphonylurea combination therapy, or substituted for either in cases of intolerance.

A - Rosiglitazone should not be used in patients with heart failure.

B - The risk of fracture should be considered in the long term care of female patients treated with rosiglitazone.

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

A - DPP-4 inhibitors may be used to improve blood glucose control in people with type 2 diabetes.

Alpha-Glucosidase Inhibitors

B - Alpha-glucosidase inhibitors can be used as monotherapy for the treatment of patients with type 2 diabetes if tolerated.

Glucagon Like Peptide-1 (GLP-1) Agonists

A - GLP-1 agonists (exenatide or liraglutide) may be used to improve glycaemic control in obese adults (body mass index [BMI] ≥30 kg/m2) with type 2 diabetes who are already prescribed metformin and/or sulphonylureas. A GLP-1 agonist will usually be added as a third line agent in those who do not reach target glycaemia on dual therapy with metformin and sulphonylurea (as an alternative to adding insulin therapy).

A - Liraglutide may be used as a third line agent to further improve glycaemic control in obese adults (BMI ≥30 kg/m2) with type 2 diabetes who are already prescribed metformin and a thiazolidinedione and who do not reach target glycaemia.

Insulin

A - Oral metformin and sulphonylurea therapy should be continued when insulin therapy is initiated to maintain or improve glycaemic control.

A - Once daily bedtime neutral protamine Hagedorm insulin should be used when adding insulin to metformin and/or sulphonylurea therapy. Basal insulin analogues should be considered if there are concerns regarding hypoglycaemia risk.

A - When commencing insulin therapy, bedtime basal insulin should be initiated and the dose titrated against morning (fasting) glucose. If the HbA1c level does not reach target then addition of prandial insulin should be considered.

A - Soluble human insulin or rapid-acting insulin analogues can be used when intensifying insulin regimens to improve or maintain glycaemic control.

Management of Diabetes in Pregnancy

Pre-Pregnancy Care

C - Pre-pregnancy care provided by a multidisciplinary team is strongly recommended for women with diabetes.

C - Pre-pregnancy glycaemic control should be maintained as close to the non-diabetic range as possible, taking into account risk of maternal hypoglycaemia.

B - All women with diabetes should be prescribed high dose pre-pregnancy folate supplementation, continuing up to 12 weeks gestation.

B - Women with diabetes initially treated in early pregnancy with metformin or sulphonylureas should be advised that these medications do not appear to carry additional risk of teratogenesis or early pregnancy loss.

Nutritional Management

D - Dietetic advice should be available in all diabetic antenatal clinics.

Optimisation of Glycaemic Control

D - All women with pre-gestational diabetes should be encouraged to achieve excellent glycaemic control.

C - Postprandial glucose monitoring should be carried out in pregnant women with gestational diabetes and may be considered in pregnant women with type 1 or 2 diabetes.

B - Continuous glucose monitoring may be considered in women with type 1 and type 2 diabetes.

B - Rapid-acting insulin analogues (lispro and aspart) appear safe in pregnancy and may be considered in individual patients where hypoglycaemia is problematic.

Complications during Pregnancy

C - Examination of the retina prior to conception and during each trimester is advised in women with type 1 and type 2 diabetes. More frequent assessment may be required in those with poor glycaemic control, hypertension or pre-existing retinopathy.

C - Early referral of pregnant women with referable retinopathy to an ophthalmologist is recommended due to the potential for rapid development of neovascularisation.

C - Women should be reassured that tight glycemic control during and immediately after pregnancy can effectively reduce the long term risk of retinopathy.

Fetal Assessment

B - All women should be offered scanning to include a detailed anomaly scan including four chamber cardiac view and outflow tracts between 20 and 22 weeks.

C - Where intrauterine growth restriction (IUGR) is suspected, regular monitoring including growth scans and umbilical artery Doppler should be carried out.

Gestational Diabetes

A - A suitable programme to detect and treat gestational diabetes should be offered to all women in pregnancy.

A - Pregnant women with gestational diabetes mellitus (GDM) should be offered dietary advice and blood glucose monitoring and be treated with glucose-lowering therapy depending on fasting and postprandial targets.

B - Metformin or glibenclamide may be considered as initial pharmacological, glucose-lowering treatment in women with gestational diabetes.

Infants of Mothers with Diabetes

B - Breastfeeding is recommended for infants of mothers with diabetes, but mothers should be supported in the feeding method of their choice.

Follow Up of Women with Gestational Diabetes Mellitus

C - Women who have developed gestational diabetes mellitus should be given diet, weight control and exercise advice.

C - Women who have developed gestational diabetes mellitus should be reminded of the need for pre-conception counselling and appropriate testing to detect progression to type 2 diabetes.

Management of Diabetic Cardiovascular Disease

Primary Prevention of Coronary Heart Disease

A - Hypertension in people with diabetes should be treated aggressively with lifestyle modification and drug therapy.

A - Target diastolic blood pressure in people with diabetes is ≤80 mm Hg.

D - Target systolic blood pressure in people with diabetes is <130 mm Hg.

A - Patients with diabetes requiring antihypertensive treatment should be commenced on:

  • An angiotensin converting enzyme (ACE) inhibitor (angiotensin-II receptor blocker [ARB] if ACE inhibitor intolerant), or
  • A calcium channel blocker, or
  • A thiazide diuretic

A - Beta-blockers and alpha blockers should not normally be used in the initial management of blood pressure in patients with diabetes.

A - Low-dose aspirin is not recommended for primary prevention of vascular disease in patients with diabetes.

A - Lipid-lowering drug therapy with simvastatin 40 mg or atorvastatin 10 mg is recommended for primary prevention in patients with type 2 diabetes aged >40 years regardless of baseline cholesterol.

B - Lipid-lowering drug therapy with simvastatin 40 mg should be considered for primary prevention in patients with type 1 diabetes aged >40 years.

Management of Patients with Diabetes and Acute Coronary Syndromes

B - Patients with clinical myocardial infarction and diabetes mellitus or marked hyperglycaemia (>11.0 mmol/l) should have immediate intensive blood glucose control. This should be continued for at least 24 hours.

A - Patients with an ST elevation acute coronary syndrome should be treated immediately with primary percutaneous coronary intervention.

D - When primary percutaneous coronary intervention cannot be provided within 90 minutes of diagnosis, patients with an ST elevation acute coronary syndrome should receive immediate thrombolytic therapy.

A - Aspirin (75 mg per day) should be given routinely and continued long term in patients with diabetes and coronary heart disease.

B - In addition to long term aspirin, clopidogrel therapy should be continued for three months in patients with non-ST elevation acute coronary syndromes.

A - In addition to long term aspirin, clopidogrel therapy should be continued for up to four weeks in patients with ST elevation acute coronary syndromes.

A - Patients with clinical myocardial infarction should be maintained on long term beta-blocker therapy.

A - Patients with clinical myocardial infarction should be commenced on long term ACE inhibitor therapy within the first 36 hours.

A - Intensive lipid-lowering therapy with atorvastatin 80 mg should be considered for patients with diabetes and acute coronary syndromes, objective evidence of coronary heart disease on angiography or following coronary revascularisation procedures.

B - Fibrate treatment can be considered in patients who are intolerant of statins.

Management of Patients with Diabetes and Heart Failure

A - Angiotensin converting enzyme inhibitors should be considered in patients with all New York Heart Association (NYHA) functional classes of heart failure due to left ventricular systolic dysfunction.

A - All patients with heart failure due to left ventricular systolic dysfunction of all NYHA functional classes should be started on beta-blocker therapy as soon as their condition is stable (unless contraindicated by a history of asthma, heart block or symptomatic hypotension).

Management of Patients with Diabetes and Stable Angina

A - All patients with stable angina due to atherosclerotic disease should receive long term standard aspirin and statin therapy.

A - All patients with stable angina should be considered for treatment with ACE inhibitors.

B - For patients with diabetes and multivessel disease, coronary artery bypass grafting (CABG) with use of the internal mammary arteries is preferred over percutaneous transluminal coronary angioplasty (PTCA).

A - Patients with diabetes undergoing angioplasty should be treated with stents where feasible, and receive adjunctive therapy with a platelet glycoprotein IIb/IIa receptor antagonist.

A - In patients with diabetes, drug-eluting stents (DES) are recommended as opposed to bare metal stents (BMS) in stable coronary heart disease or non-ST elevation myocardial infarction to reduce in-stent re-stenosis and target lesion revascularisation.

Management of Kidney Disease in Diabetes

Screening for Kidney Disease in Diabetes

B - Albumin/creatinine ratio (ACR) should be used to screen for diabetic kidney disease.

C - Young people with diabetes should have ACR tested annually from the age of 12 years.

Prevention and Treatment of Kidney Disease in Diabetes

A - Intensive glycaemic control in people with type 1 and 2 diabetes should be maintained to reduce the risk of developing diabetic kidney disease.

A - Reducing proteinuria should be a treatment target regardless of baseline urinary protein excretion. However, patients with higher degrees of proteinuria benefit more. There should be no lower target as the greater the reduction from baseline urinary protein excretion, the greater the effect on slowing the rate of loss of glomerular filtration rate (GFR).

A - In people with diabetes and kidney disease, blood pressure should be reduced to the lowest achievable level to slow the rate of decline of glomerular filtration rate and reduce proteinuria.

A - People with type 1 diabetes and microalbuminuria should be treated with an ACE inhibitor irrespective of blood pressure.

A - People with type 2 diabetes and microalbuminuria should be treated with an ACE inhibitor or an angiotensin-II receptor blocker irrespective of blood pressure.

A - ACE inhibitors and/or angiotensin-II receptor blockers should be used as agents of choice in patients with chronic kidney disease and proteinuria (≥0.5 g/day, approximately equivalent to a protein/creatinine ratio of 50 mg/mmol) to reduce the rate of progression of chronic kidney disease.

A - Dietary protein restrictions (<0.8 g/kg/day) are not recommended in patients with early stages of chronic kidney disease (stages 1-3).

B - People with diabetes and microalbuminuria should be treated with a multifactorial intervention approach.

Management of Complications

D - Patients with diabetes and chronic kidney disease (CKD) stage 3-5 should have their haemoglobin checked at least annually.

A - Erythropoiesis stimulating agents should be considered in all patients with anaemia of chronic kidney disease, including those with diabetic kidney disease.

Models of Care

D - Individuals with diabetes and mild to moderate CKD should be managed in a setting that can provide appropriate investigation, monitoring and intensive clinical management.

Prevention of Visual Impairment

Risk Identification and Prevention

B - Patients with multiple risk factors should be considered at high risk of developing diabetic retinal disease.

A - Good glycaemic control (HbA1c ideally around 7% or 53 mmol/mol) and blood pressure control (<130/80 mm Hg) should be maintained to prevent onset and progression of diabetic eye disease.

B - Laser photocoagulation, if required, should be completed before any rapid improvements in glycaemic control are achieved.

Screening

B - Systematic screening for diabetic retinal disease should be provided for all people with diabetes.

C - Patients with type 1 diabetes should be screened from age 12 years.

A - Patients with type 2 diabetes should be screened from diagnosis.

B -

  • Patients with diabetes with no diabetic retinopathy could be screened every two years.
  • All others should be screened at least annually.

C - Retinal photography or slit lamp biomicroscopy used by trained individuals should be used in a programme of systematic screening for diabetic retinopathy.

Either good quality 7-field stereoscopic photography or slit lamp biomicroscopy (both dilated) carried out by an appropriately experienced ophthalmologist should be used to investigate:

A -

  • Clinically significant macular oedema

B -

  • Proliferative diabetic retinopathy and severe non-proliferative diabetic retinopathy.

C - Dilated direct ophthalmoscopy should only be used opportunistically.

D - Screening modalities should aim to detect sight-threatening retinal disease with a sensitivity ≥80% and specificity ≥95%.

B - Patients with ungradeable retinal photographs should receive slit lamp and indirect ophthalmoscopy examination where possible.

D - Screening should be performed at a site convenient to patients.

C - Retinal photographs should be graded using digital images by an appropriately trained grader to facilitate quality assurance.

D - All graders should have 500 retinal photographs rechecked for quality assurance each year.

B - Either one field 45-50° retinal photography, or multiple field photography can be used for screening purposes.

B - Automated grading may be used for distinguishing no retinopathy from any retinopathy in a screening programme providing validated software is used.

Treatment

A -

  • All people with type 1 or type 2 diabetes with new vessels at the disc or iris should receive laser photocoagulation.
  • Laser photocoagulation should also be provided for patients with new vessels elsewhere with vitreous haemorrhage.
  • All people with type 2 diabetes and new vessels elsewhere should receive laser photocoagulation.

D - All people with type 1 diabetes with new vessels elsewhere should receive laser photocoagulation.

A - Patients with severe or very severe non-proliferative diabetic retinopathy should receive close follow up or laser photocoagulation.

A - Modified Early Treatment Diabetic Retinopathy Study (ETDRS) grid laser photocoagulation should be used for patients with clinically significant macular oedema in the absence of significant macular ischaemia.

B - Patients with type 1 diabetes and persistent vitreous haemorrhage should be referred for early vitrectomy.

B - Vitrectomy should be performed in patients with tractional retinal detachment threatening the macula and should be considered in patients with severe fibrovascular proliferation.

B - Cataract extraction should not be delayed in patients with diabetes.

C - Cataract extraction is advised when sight-threatening retinopathy cannot be excluded.

C - When cataract extraction is planned in the context of advanced disease, which is not stabilised prior to surgery, the risk of progression and the need for close postoperative review should be fully discussed with the patient.

Rehabilitation

D - Community support, maximising disability benefits, low vision aids and training in their use should be provided to people with diabetes and visual impairment.

Management of Diabetic Foot Disease

Prevention Management

B - All patients with diabetes should be screened to assess their risk of developing a foot ulcer.

B - Foot care education is recommended as part of a multidisciplinary approach in all patients with diabetes.

B - Patients with diabetic foot disease should be advised to wear running-style, cushion-soled trainers rather than ordinary shoes.

B - Custom-built footwear or orthotic insoles should be used to reduce callus severity and ulcer recurrence.

Management of Active Foot Disease

C - Patients with active diabetic foot disease should be referred to a multidisciplinary diabetic foot care service.

B - Patients who have unilateral plantar ulcers should be assessed for treatment using total contact casting to optimise the healing rate of ulcers.

B - Prefabricated walkers can be used as an alternative if they are rendered irremovable.

B - Negative pressure wound therapy should be considered in patients with active diabetic foot ulcers or postoperative wounds.

B - All patients with critical limb ischaemia, including rest pain, ulceration and tissue loss, should be considered for arterial reconstruction.

C -

  • Diagnosis of Charcot neuroarthropathy of the foot should be made by clinical examination.
  • Post-diagnosis thermography can be used to monitor disease activity.

D - Total contact casting and non-weight bearing are effective treatments for patients with acute Charcot neuroarthropathy of the foot.

Painful Diabetic Neuropathy

A - Antidepressants, including tricyclics, duloxetine and venlafaxine should be considered for the treatment of patients with painful diabetic peripheral neuropathy (DPN).

A - Anticonvulsants, including pregabalin and gabapentin, should be considered for the treatment of patients with painful DPN.

B - Opiate analgesia in combination with gabapentin should be considered for the treatment of patients with painful DPN which cannot be controlled with monotherapy.

Definitions:

Grades of Recommendation

A: At least one meta-analysis, systematic review, or randomized controlled trial (RCT) rated as 1++, and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B: 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 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+

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

2++: High quality systematic reviews of case control or cohort studies

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-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies, e.g., case reports, case series

4: Expert opinion

Clinical Algorithm(s)

An algorithm for glucose-lowering in people with type 2 diabetes is available in the original guideline document.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Appropriate management of cardiovascular, kidney, and foot diseases; visual impairment; pregnant women with diabetes; psychosocial issues; type 1 diabetes; and glucose-lowering therapies in people with type 2 diabetes
  • Development of high quality care for people with diabetes
  • Appropriate management of cardiovascular risk factors such as smoking, physical inactivity, and poor diet is important for the prevention of macrovascular disease.
  • Psychosocial interventions are generally acceptable to patients, increase patient satisfaction with treatment, and apply across the spectrum of children, adolescents, and adults with type 1 and type 2 diabetes, including those whose diabetes is poorly controlled.
  • The immediate purpose of lowering blood glucose is to provide relief from symptoms (thirst, polyuria, nocturia, and blurred vision). Thereafter, the aim is to prevent microvascular complications: loss of vision (retinopathy), renal failure (nephropathy), and foot ulceration (neuropathy). High blood glucose (hyperglycaemia) is also one of the features of diabetes - with raised blood pressure and cholesterol - associated with macrovascular complications (myocardial infarction, stroke, and peripheral arterial disease). The effects of glucose-lowering therapies on cardiovascular morbidity and mortality are therefore of major importance and not necessarily related to glucose-lowering.
Potential Harms

Lifestyle Management

  • There is higher risk of myocardial infarction (MI) after heavy exertion in sedentary compared with non-sedentary people with type 1 diabetes.
  • Exercise with normal insulin dose and no additional carbohydrate significantly increases the risk of hypoglycemia during and after exercise. Injection of insulin into exercising areas increases the absorption of insulin and the risk of hypoglycaemia and should therefore be avoided. High temperatures can also increase insulin absorption. This should be taken into consideration when exercising in hot climates. A further reduction in insulin dose may be required.
  • Gastrointestinal side effects were common with orlistat; tremor, somnolence and sweating with fluoxetine; and palpitations with sibutramine.*

*Note from the National Guideline Clearinghouse (NGC): On October 8, 2010, Abbott Laboratories and the U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke. Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs. See the FDA Web site External Web Site Policy for more information.

Insulin Therapy

Severe hypoglycemia may adversely affect quality of life in patients treated with insulin, particularly in those newly diagnosed.

Metformin

The main adverse event reported more frequently with metformin compared with placebo in one systematic review was diarrhoea (absolute risk increase [ARI] 6.8%; relative risk [RR] 3.09, 95% confidence interval [CI] 1.58 to 6.07). Hypoglycaemia was reported more frequently with metformin compared with diet (ARI 2.9%; RR 4.21, 95% CI 1.40 to 12.66).

Sulphonylureas

  • United Kingdom Prospective Diabetes Study (UKPDS) 33 showed a higher rate of major hypoglycaemia (defined as requiring third party help or medical intervention) in patients on sulphonylureas than diet alone and weight gain was greater (chlorpropamide 2.6 kg, glibenclamide 1.7 kg). A Scottish population based study showed that one person with type 2 diabetes in every 100 treated with a sulphonylurea each year experienced an episode of major hypoglycaemia, compared with one in every 2,000 treated with metformin and one in every 10 treated with insulin. One randomized controlled trial (RCT) over 27 weeks showed a significant reduction in confirmed hypoglycaemia (<3 mmol/l) with gliclazide modified release (MR) versus glimepiride, while body weight increase was equivalent. One systematic review reported no confirmed episodes of hypoglycaemia (defined as plasma glucose ≤3.3 mmol) with either glimepiride or placebo over 14 weeks. Reported hypoglycaemic symptoms and confirmed hypoglycaemia were no more frequent compared with placebo in patients taking glipizide and glimepiride over 3 to 4 months. Weight gain of 4.8 kg was observed in the glimepiride arm versus placebo.
  • Concerns dating from the early 1970s regarding the cardiovascular safety of sulphonylureas continue to receive support from observational evidence. For example, in one large retrospective cohort study, there was a 24-61% excess risk for all-cause mortality with sulphonylureas in comparison with metformin.

Thiazolidinedione (TZD)

  • One meta-analysis reported TZD use to be associated with an increased risk of peripheral fracture among women with type 2 diabetes (odds ratio [OR] 2.23, 95% CI 1.65 to 3.01). In this meta-analysis there was no increased risk in men (OR 1.00, 95% CI 0.73 to 1.39).
  • One prospective population based cohort study confirmed TZD use compared to sulphonylurea use was associated with a 28% increased risk of peripheral fracture in both men and women (hazard ratio [HR] 1.28, 95% CI 1.10 to 1.48).

Pioglitazone

  • A systematic review of 18 RCTs with 11,565 participants providing loosely defined data on oedema reported a raised incidence of oedema (RR 2.86, 95% CI 2.14 to 3.18). This finding has been supported by other meta-analyses.
  • Pioglitazone is associated with weight gain.

Rosiglitazone

  • Rosiglitazone treatment is associated with weight gain and oedema.
  • Analysis of A Diabetes Outcome Progression Trial (ADOPT) revealed that rosiglitazone use versus comparator was associated with an increased risk of peripheral fractures in women (HR versus metformin 1.81, 95% CI 1.17 to 2.80; HR versus glyburide 2.13, 95% CI 1.30 to 3.51). Similar analysis of Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes (RECORD) confirmed the ADOPT findings (RR versus control 1.57, 95% CI 1.26 to 1.97; RR for women 1.82, 95% CI 1.37 to 2.41; RR for men 1.23, 95% 0.85 to 1.77).

Dipeptidyl Peptidase-4 Inhibitors

A Cochrane review reported a statistically significant increase in all-cause infection following treatment with sitagliptin (RR 1.29, 95% CI 1.09 to 1.52, p=0.003) but not following treatment with vildagliptin (RR 1.04, 95% CI 0.87 to 1.24, p=0.7).

Alpha-glucosidase Inhibitors

Compared with placebo, alpha-glucosidase inhibitors have minimal effects on body weight. Abdominal discomfort (flatulence, diarrhoea and stomach ache) are the most frequently occurring adverse effects of alpha-glucosidase inhibitors and are dose related (acarbose ARI 25.8%, OR 3.3, 95% CI 2.3 to 4.7). The prevalence of gastrointestinal symptoms associated with acarbose (range, 15% to 30%) is similar to that with metformin and higher than that with thiazolidinediones or sulphonylureas (<3 trials for each comparison). One RCT reported an incidence of 51% of patients reporting adverse events.

Meglitinides

Weight gain was more common (up to 3 kg in three months) and hypoglycaemia was more frequent in those treated with meglitinides compared with metformin.

Glucagon like Peptide-1 (GLP-1) Agonists

In the studies discussed in the original guideline document, GLP-1 agonists were generally well tolerated; the most frequent adverse events were gastrointestinal, especially nausea, which was generally reported as mild to moderate (OR 3.88 95% CI 2.79 to 5.42, p<0.001). Severe hypoglycaemia was rare in exenatide and liraglutide studies and occurred only when sulphonylureas were co-prescribed. Mild to moderate hypoglycaemia was seen in 16% versus 7% of patients treated with exenatide versus placebo (risk ratio 2.3; 95% CI 1.1 to 4.9). In one study, 25.5% of patients treated with liraglutide versus 33.6% of patients treated with exenatide reported minor hypoglycaemia, p=0.01.

Aspirin

There are major gastrointestinal complications associated with the use of aspirin therapy.

Clopidogrel

In one study, bleeding risks with clopidogrel were consistently higher after 3 months of therapy.

Angiotensin-converting Enzyme (ACE) Inhibitor Therapy

Angiotensin-converting enzyme inhibitors can induce cough or rash.

Breastfeeding

Although most medicines are not licensed for use in lactation, specialist reference sources provide information on suitability of medicines in breast feeding. Insulin, metformin, and glibenclamide are considered compatible with breast feeding, although the infant should be observed for signs of hypoglycaemia. The antihypertensives commonly used in pregnancy — labetalol, nifedipine and methyldopa — are found in breast milk in low concentration and these agents are considered appropriate for use in breastfeeding mothers, although with labetalol the infant should be monitored for bradycardia and hypotension. Statins are not recommended in breast feeding. Information on use of aspirin is conflicting with some sources advising low-dose aspirin is safe in breast feeding, while others advise cautious use due to potential for toxicity. Others do not recommend it due to potential risk of Reye's syndrome in the infant although amounts of aspirin in breast milk from antiplatelet doses will be very low.

Beta-blockers

Beta blocker therapy should be avoided in patients with acute pulmonary oedema and acute left ventricular failure.

Atorvastatin

The main side effect reported in two atorvastatin studies was an increase in abnormalities of liver function tests.

Contraindications

Contraindications
  • The combined oral contraceptive (COC) is contraindicated in women with diabetes according to the presence and severity of diabetic complications and/or other risk factors for vascular disease.
  • A reference guide to medications in pregnancy and lactation reported that atorvastatin, fluvastatin, pravastatin and simvastatin are contraindicated in pregnancy and lactation.
  • Thiazolidinediones (TZDs) are contraindicated in patients with New York Heart Association (NYHA) III or IV heart failure.
  • Beta-blockers are contraindicated in patients with asthma, second or third degree atrioventricular heart block, or symptomatic hypotension and should be used with caution in those with low initial blood pressure (i.e., systolic blood pressure [BP] <90 mm Hg).

Qualifying Statements

Qualifying Statements
  • This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken.
  • Every care is taken to ensure that the original guideline document 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 the web site www.sign.ac.uk External Web Site Policy.

Implementation of the Guideline

Description of Implementation Strategy

Implementing the Guideline

Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. Mechanisms should be in place to review care provided against the guideline recommendations. The reasons for any differences should be assessed and addressed where appropriate. Local arrangements should then be made to implement the national guideline in individual hospitals, units and practices.

Resource Implications of Key Recommendations

A cost and resource impact report and an associated spreadsheet have been developed to provide each NHS board with resource and cost information to support the implementation of the recommendations judged to have a material impact on resources (see Table 7 in the original guideline document). These documents are available from the Scottish Intercollegiate Guidelines Network (SIGN) website: www.sign.ac.uk External Web Site Policy.

Auditing Current Practice

A first step in implementing a clinical practice guideline is to gain an understanding of current clinical practice. Audit tools designed around guideline recommendations can assist in this process. Audit tools should be comprehensive but not time consuming to use. Successful implementation and audit of guideline recommendations requires good communication between staff and multidisciplinary team working.

The guideline development group has identified the key points in the original guideline document to audit to assist with the implementation of this guideline.

Implementation Tools
Audit Criteria/Indicators
Clinical Algorithm
Patient Resources
Quick Reference Guides/Physician Guides
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Scottish Intercollegiate Guidelines Network (SIGN). Management of diabetes. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2010 Mar. 170 p. (SIGN publication; no. 116).  [759 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2001 Nov (revised 2010 Mar)
Guideline Developer(s)
Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]
Source(s) of Funding

Scottish Executive Health Department

Guideline Committee

Not stated

Composition of Group That Authored the Guideline

The Guideline Development Group

Lifestyle Subgroup

Dr Stephen Gallacher (Chair); Dr Karen Adamson; Dr Satinder Bal; Ms Janet Barclay; Dr Christine Findlay; Dr Helen Hopkinson; Dr Alison Kirk; Dr Vincent McAulay; Dr Katharine Morrison; Dr Rebecca Reynolds; Dr Vivien Swanson; Dr Debbie Wake; Ms Sunita Wallia

Type 1 Diabetes Subgroup

Dr Michael Small (Chair); Dr Ian Craigie; Mrs Alison Johnston; Dr Andrew Keen; Dr Chris Kelly; Mrs Heather Maxwell; Dr Amalia Mayo; Dr Colin Perry; Dr Scott Williamson

Type 2 Diabetes Subgroup

Dr John Petrie (Chair); Dr Greg Jones; Dr Simon Maxwell; Ms Joan McDowell; Dr David McGrane; Dr Liz McIntyre; Dr Mary Joan McLeod; Dr Ewan Pearson; Mrs Ailsa Power; Dr Richard Quigley; Dr Sarah Wild

Pregnancy Subgroup

Dr Robbie Lindsay (Chair); Dr Roddy Campbell; Miss Ellen Davidson; Dr Russell Drummond; Dr Lesley Jackson; Dr Corinne Love; Sister Trish McCue; Dr Neil Myers; Dr Norman Smith; Ms Maria Tracey

Cardiovascular Disease Subgroup

Professor Miles Fisher (Chair); Miss Alison Cockburn; Dr Ellie Dow; Dr Alistair Emslie-Smith; Dr Andrew Gallagher; Professor Martin McIntyre; Dr Gerry McKay; Mrs Isobel Miller; Dr Mark Petrie

Kidney Subgroup

Dr Mark Strachan (Chair); Dr Corri Black; Dr Jane Goddard; Dr Nicola Joss; Dr Izhar Khan; Dr Alan Patrick

Visual Impairment Subgroup

Dr Graham Leese (Chair); Dr Graham Cormack; Dr Roderick Harvey; Ms Fiona Heggie; Dr John Hinnie; Dr Peter Leslie; Dr Alasdair Mackie; Mr Frank Munro; Dr John Olson; Mr David Paul; Dr Caroline Styles; Dr Graeme Williams; Mrs Sandra Wilson

Foot Disease Subgroup

Dr Brian Kennon (Chair); Ms Margaret Doyle; Dr Murray Flett; Mr Amar Jain; Ms May Lavelle; Mr Kenneth Moyes; Mr William Munro; Dr Iain O'Brien; Miss Diane Snell; Mr Duncan Stang; Dr Matthew Young

The Guideline Steering Group

Dr John McKnight (Chair); Mr Naseem Anwar; Dr Miles Fisher; Dr Stephen Gallacher; Dr Roberta James; Mrs Jane-Claire Judson; Dr Brian Kennon; Dr Graham Leese; Dr Robbie Lindsay; Mrs Isobel Miller; Dr Moray Nairn; Mrs Anne Paris; Mr David Paul; Dr Donald Pearson; Dr John Petrie; Miss Mary Scott; Dr Michael Small; Mrs Ailsa Stein; Dr Mark Strachan

Financial Disclosures/Conflicts of Interest

Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Scottish Intercollegiate Guidelines Network (SIGN). Management of diabetes. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2001 Nov. 50 p. (SIGN publication; no. 55). [388 references]

Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network Web site External Web Site Policy.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site. External Web Site Policy

Availability of Companion Documents

The following are available:

  • Quick reference guide: Management of diabetes. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network; 2010 Mar. 20 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site External Web Site Policy.
  • Summary of recommendations: Management of diabetes. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network; 2010 May. 12 p. Available from the SIGN Web site External Web Site Policy.
  • Costing template: Management of diabetes. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network; 2010 May. Available from the SIGN Web site External Web Site Policy.
  • SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site External Web Site Policy.
  • Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network; 2001. Available from the SIGN Web site External Web Site Policy.
Patient Resources

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI on April 17, 2002. The information was verified by the guideline developer on July 11, 2002. This summary was updated ECRI Institute on August 26, 2010. This summary was updated by ECRI Institute on March 16, 2011 following the U.S. Food and Drug Administration advisory on negative pressure wound therapy (NPWT) systems. This summary was updated by ECRI Institute on June 27, 2011 following the U.S. Food and Drug Administration advisory on Zocor (simvastatin). This summary was updated by ECRI Institute on July 15, 2011 following the U.S. Food and Drug Administration advisory on erythropoiesis-stimulating agents (ESAs) in chronic kidney disease. This summary was updated by ECRI Institute on April 13, 2012 following the U.S. Food and Drug Administration advisories on Statin Drugs and Statins and HIV or Hepatitis C drugs. This summary was updated by ECRI Institute on April 4, 2014 following the U.S. Food and Drug Administration (FDA) advisory on Rosiglitazone-containing Diabetes Medicines.

Copyright Statement

Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit.

Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net.

Additional copyright information is available on the SIGN Web site External Web Site Policy.

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