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Guideline Summary
Guideline Title
Type 2 diabetes. The management of type 2 diabetes.
Bibliographic Source(s)
National Collaborating Centre for Chronic Conditions. Type 2 diabetes. The management of type 2 diabetes. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 May. 49 p. (Clinical guideline; no. 87). 
Guideline Status

This is the current release of the guideline.

This release updates a previously published guideline: National Collaborating Centre for Chronic Conditions. Type 2 diabetes. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 May. 44 p. (Clinical guideline; no. 66).

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.

  • November 25, 2013 – Rosiglitazone-containing Diabetes Medicines External Web Site Policy: The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).

Scope

Disease/Condition(s)

Type 2 diabetes

Guideline Category
Counseling
Evaluation
Management
Treatment
Clinical Specialty
Endocrinology
Family Practice
Internal Medicine
Nephrology
Neurology
Ophthalmology
Intended Users
Advanced Practice Nurses
Dietitians
Health Care Providers
Hospitals
Nurses
Patients
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)

  • To offer best practice advice on the care of people with type 2 diabetes
  • To provide a user-friendly, clinical, evidence-based guideline for the National Health Service (NHS) in England and Wales that:
    • Offers best clinical advice for the management of type 2 diabetes
    • Is based on the best published clinical and economic evidence, alongside expert consensus
    • Takes into account patient choice and informed decision making
    • Defines the major components of NHS care provision for type 2 diabetes
    • Details areas of uncertainty or controversy requiring further research
    • Provides a choice of guideline versions for differing audiences

Target Population

People with type 2 diabetes

Note: The guideline does not address care in or before pregnancy, or care by specialist services for specific advanced organ damage (cardiac, renal, eye, vascular, stroke and other services).

Note: The application of the guideline to children has not been excluded but the guideline developers were not able to specifically search for paediatric literature due to volume of work. When health carers are applying these guidelines to children they need to use their clinical judgement in doing so. For further assistance with applying this guideline to children please refer to the British National Formulary (BNF) for children.

Interventions and Practices Considered

  1. Patient education
  2. Lifestyle modification
    • Dietary advice
    • Weight management
    • Increase physical activity
    • Management of depression
  3. Management of glucose control levels
    • Targeting glycated haemoglobin level
    • Self-monitoring of plasma glucose
    • Oral glucose control therapies
      • Metformin
      • Insulin secretagogues
      • Acarbose
      • Dipeptidyl peptidase-4 (DPP-4) inhibitors
        • Sitagliptin
        • Vildagliptin
      • Thiazolidinediones
        • Pioglitazone
        • Rosiglitazone
      • Glucagon-like peptide-1 (GLP-1) mimetic
        • Exenatide
    • Insulin therapy
      • Combination oral agent and insulin
      • Insulin therapy structured program
      • Insulin delivery devices
    • Blood pressure therapy
    • Estimation of cardiovascular risk
    • Management of blood lipid levels
      • Statins and ezetimibe
      • Fibrates
      • Omega-3 fish oils
    • Anti-thrombotic therapy
    • Assessment of kidney damage (urine albumin:creatinine ratio, estimated glomerular filtration rate)
    • Eye surveillance annually
    • Management of nerve damage
      • Neuropathic pain management
      • Gastroparesis management (referral to specialist, trial of metoclopramide, domperidone, erythromycin)
      • Management of erectile dysfunction (annual review, phosphodiesterase-5 inhibitor, medical, surgical, or psychological management)
      • Other aspects of autonomic neuropathy

Major Outcomes Considered

  • Cost effectiveness
  • Haemoglobin A1c 
  • Glucose control
  • Blood lipid levels
  • Quality of life
  • Incidence of microvascular complications
  • Effectiveness of medications
  • Adherence to treatment regimen

Methodology

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

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Chronic Conditions (NCC-CC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Searching for the Evidence

The information scientist developed a search strategy for each question. Key words for the search were identified by the Guideline Development Group (GDG). In addition, the health economist searched for additional papers providing economic evidence or to inform detailed health economic work (for example, modelling). Papers that were published or accepted for publication in peer-reviewed journals were considered as evidence by the GDG. Conference paper abstracts and non-English language papers were excluded from the searches.

Each clinical question dictated the appropriate study design that was prioritised in the search strategy, but the strategy was not limited solely to these study types. The research fellow or health economist identified titles and abstracts from the search results that appeared to be relevant to the question. Exclusion lists were generated for each question together with the rationale for the exclusion. The exclusion lists were presented to the GDG. Full papers were obtained where relevant. See appendix A of the full version of National Institute for Health and Clinical Excellence (NICE) clinical guideline 66 (see the "Availability of Companion Documents" field) for literature search details. Available from the Royal College of Physicians Web site External Web Site Policy.

Short Clinical Guideline: Newer Agents for Blood Glucose Control in Type 2 Diabetes (Applies to Sections 1.6 [Oral Glucose Control Therapies (2): Other Oral Agents and Exenatide] and 1.7.2 [Insulin Therapy] of the NICE Version of CG 87)

Literature Search

Note from the National Guideline Clearinghouse (NGC): A technology assessment report was commissioned by the UK Health Technology Assessment (HTA) Programme from the Aberdeen Health Technology Assessment Group (Appendix 6.2 in the Short Clinical Guideline Appendices document [see the "Availability of Companion Documents" field]). This technology assessment report was used as the primary source of evidence considered by the Guideline Development Group (GDG).

The search strategies for the evidence review were developed by the Aberdeen HTA Group. The strategies were run across a number of databases, with no date restrictions imposed on the searches.

Because the technology assessment report included de novo health economic modelling, no further searches were undertaken to identify other published health economic evaluations.

In addition to the systematic literature searches, the GDG was asked to alert the Short Clinical Guidelines Technical Team to any additional evidence, published, unpublished or in press, that met the inclusion criteria.

Reviewing the Evidence

The Aberdeen HTA Group had primary responsibility for reviewing the evidence but was supported by the Short Clinical Guidelines Technical Team as appropriate. The methods of the technology assessment report are shown in appendix 6.2 of the Short Clinical Guideline Appendices document (see the "Availability of Companion Documents" field).

Studies suggested or submitted by the GDG and expert advisers were also reviewed for relevance to the key clinical questions and included if they met the inclusion criteria.

The Short Clinical Guidelines Technical Team was responsible for ensuring that appropriate review methods were used and that the final review met the needs of the GDG.

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 for Intervention Studies

Level of Evidence Type of Evidence
1++ High-quality meta-analyses, systematic reviews of randomised controlled trials (RCTs) or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews of RCTs or RCTs with a low risk of bias
1− Meta-analyses, systematic reviews of RCTs 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, bias or chance and a high probability that the relationship is causal
2+ Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal
2− Case–control or cohort studies with a high risk of confounding bias or chance and a significant risk that the relationship is not causal*
3 Non-analytic studies (for example, case reports and case series)
4 Expert opinion, formal consensus

*Studies with a level of evidence ′–′ should not be used as a basis for making a recommendation.

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

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Chronic Conditions (NCC-CC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Appraising the Evidence

The research fellow or health economist, as appropriate, critically appraised the full papers. In general, no formal contact was made with authors; however, there were ad hoc occasions when this was required in order to clarify specific details. Critical appraisal checklists were compiled for each full paper. One research fellow undertook the critical appraisal and data extraction. The evidence was considered carefully by the Guideline Development Group (GDG) for accuracy and completeness.

All procedures are fully compliant with the:

  • National Institute for Health and Clinical Excellence (NICE) methodology as detailed in the 'Guideline Development Methods – Information for National Collaborating Centres and Guideline Developers' Manual (see "Availability of Companion Documents" field)
  • NCC-CC quality assurance document and systematic review chart

Distilling and Synthesising the Evidence

The evidence from each full paper was distilled into an evidence table and synthesised into evidence statements before being presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations. The criteria for grading evidence are shown in "The Rating Scheme for the Strength of the Evidence" field.

Evidence tables are available online at the Royal College of Physicians Web site External Web Site Policy.

Short Clinical Guideline: Newer Agents for Blood Glucose Control in Type 2 Diabetes (Applies to Sections 1.6 [Oral Glucose Control Therapies (2): Other Oral Agents and Exenatide] and 1.7.2 [Insulin Therapy] of the NICE Version of CG 87)

Note from the National Guideline Clearinghouse (NGC): A technology assessment report was commissioned by the UK Health Technology Assessment (HTA) Programme from the Aberdeen Health Technology Assessment Group (Appendix 6.2 in the Short Clinical Guideline Appendices document [see the "Availability of Companion Documents" field]). This technology assessment report was used as the primary source of evidence considered by the Guideline Development Group (GDG).

Grading the Evidence

Intervention Studies

Studies that meet the minimum quality criteria were ascribed a level of evidence to help the guideline developers and the eventual users of the guideline understand the type of evidence on which the recommendations have been based.

There are many different methods for assigning levels to the evidence and there has been considerable debate about which system is best. A number of initiatives are currently underway to find an international consensus on the subject. NICE has previously published guidelines using different systems and is now examining a number of systems in collaboration with the National Collaborating Centres and academic groups throughout the world to identify the most appropriate system for future use.

Until a decision is reached on the most appropriate system for NICE guidelines, the Short Clinical Guidelines Technical Team will use the system for evidence shown in the "Rating Scheme for the Strength of the Evidence" field.

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

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Chronic Conditions (NCC-CC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Agreeing the Recommendations

The Guideline Development Group (GDG) employed formal consensus techniques to:

  • Ensure that the recommendations reflected the evidence base
  • Approve recommendations based on lesser evidence or extrapolations from other situations
  • Reach consensus recommendations where the evidence was inadequate
  • Debate areas of disagreement and finalise recommendations

The GDG also reached agreement on the following:

  • Five recommendations as key priorities for implementation
  • Five key research recommendations
  • Algorithms

In prioritising key recommendations for implementation, the GDG took into account the following criteria:

  • High clinical impact
  • High impact on reducing variation
  • More efficient use of National Health Service resources
  • Allowing the patient to reach critical points in the care pathway more quickly

Audit criteria for this guideline will be produced for NICE by Clinical Accountability Service Planning and Evaluation (CASPE) Research following publication in order to provide suggestions of areas for audit in line with the key recommendations for implementation.

Writing the Guideline

The first draft version of the guideline was drawn up by the technical team in accord with the decisions of the GDG, incorporating contributions from individual GDG members in their expert areas and edited for consistency of style and terminology. The guideline was then submitted for a formal public and stakeholder consultation prior to publication. The registered stakeholders for this guideline are detailed on the NICE website, www.nice.org.uk External Web Site Policy. Editorial responsibility for the full guideline rests with the GDG.

Short Clinical Guideline: Newer Agents for Blood Glucose Control in Type 2 Diabetes (Applies to Sections 1.6 [Oral Glucose Control Therapies (2): Other Oral Agents and Exenatide] and 1.7.2 [Insulin Therapy] of the NICE Version of CG 87)

Note from the National Guideline Clearinghouse (NGC): A technology assessment report was commissioned by the UK Health Technology Assessment (HTA) Programme from the Aberdeen Health Technology Assessment Group (Appendix 6.2 in the Short Clinical Guideline Appendices document [see the "Availability of Companion Documents" field]). This technology assessment report was used as the primary source of evidence considered by the GDG.

Interpreting the Evidence to Make Recommendations

The evidence review for the key clinical questions being discussed was made available to the GDG 1 week before the scheduled GDG meeting. All GDG members were expected to have read the evidence review before attending each meeting. The review of the evidence had three components. First, the GDG discussed the evidence report and corrected any factual errors or incorrect interpretation of the evidence. Second, evidence statements, which had been drafted by the Short Clinical Guidelines Technical Team, were presented to the GDG and the GDG agreed the correct wording of these. Third, from a discussion of the evidence statements and the experience of GDG members, recommendations were drafted. The Short Clinical Guidelines Technical Team explicitly flagged up with the GDG that it should consider the following criteria (considered judgement) when developing the guideline recommendations from the evidence presented:

  • Internal validity
  • Consistency
  • Generalisability (external validity)
  • Clinical impact
  • Cost effectiveness
  • Ease of implementation
  • Patients' perspective
  • Overall synthesis of evidence

For each key question, recommendations were derived from the evidence summaries and statements presented to the GDG. The recommendations were evidence based if possible; if evidence was not available, informal consensus of opinion within the GDG was used. The need for future research was also specified. The process by which the evidence statements informed the recommendations is summarised in the section ‘Interpreting the evidence to make recommendations’ in the relevant evidence review.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Health Economic Evidence

Areas for health economic modelling were agreed by the Guideline Development Group (GDG) after the formation of the clinical questions. The health economist reviewed the clinical questions to consider the potential application of health economic modelling, and these priorities were agreed with the GDG.

The health economist performed supplemental literature searches to obtain additional data for modelling. Assumptions and designs of the models were explained to and agreed by the GDG members during meetings, and they commented on subsequent revisions. 

Health economic evidence statements, when available, are provided in the relevant sections of the full version of the original guideline document.

Short Clinical Guideline: Newer Agents for Blood Glucose Control in Type 2 Diabetes (Applies to Sections 1.6 [Oral Glucose Control Therapies (2): Other Oral Agents and Exenatide] and 1.7.2 [Insulin Therapy] of the NICE Version of CG 87)

Health Economics

An economic evaluation aims to integrate data on the benefits (ideally in terms of quality of life years [QALYs]), harms and costs of alternative options. An economic appraisal will consider not only whether a particular course of action is clinically effective, but also whether it is cost effective (that is, value for money). If a particular treatment strategy were found to yield little health gain relative to the resources used, then it could be advantageous to redirect resources to other activities that yield greater health gain.

A systematic review of the economic literature relating to the use of newer agents in type 2 diabetes was also conducted. In addition, the Guideline Development Group (GDG) and expert advisers were questioned over any potentially relevant unpublished data.

Health economics statements are made in the guideline in sections in which the use of National Health Service (NHS) resources is considered.

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

The first draft version of the guideline was drawn up by the technical team in accord with the decisions of the Guideline Development Group (GDG), incorporating contributions from individual GDG members in their expert areas and edited for consistency of style and terminology. The guideline was then submitted for a formal public and stakeholder consultation prior to publication. The registered stakeholders for this guideline are detailed on the NICE website, www.nice.org.uk External Web Site Policy. Editorial responsibility for the full guideline rests with the GDG.

Short Clinical Guideline: Newer Agents for Blood Glucose Control in Type 2 Diabetes (Applies to Sections 1.6 [Oral Glucose Control Therapies (2): Other Oral Agents and Exenatide] and 1.7.2 [Insulin Therapy] of the NICE Version of CG 87.)

The guidance has been developed in accordance with the NICE guideline development process for short clinical guidelines. This has included allowing registered stakeholders the opportunity to comment on the draft guidance. In addition, the first draft was reviewed by an independent Guideline Review Panel established by NICE.

The comments made by stakeholders, peer reviewers and the Guideline Review Panel were collated and presented for consideration by the GDG. All comments were considered systematically by the GDG, and the Short Clinical Guidelines Technical Team recorded the agreed responses.

Recommendations

Major Recommendations

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Chronic Conditions (NCC-CC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Note from NICE: This guideline is a partial update of NICE clinical guideline 66 and replaces it.

The recommendations in sections "Oral Glucose Control Therapies (2); Other Oral Agents and Exenatide" and "Insulin Therapy" have been updated by the short clinical guideline 'Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes,' and are new [new 2009] or unchanged. This short guideline addresses the licensed indications of drugs as of September 2008. The recommendations do not apply to drugs not yet available in the UK and exclude liraglutide, which did not receive UK marketing authorisation for type 2 diabetes during the development of this guideline. Recommendations are consistent with safety information from the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency.

Patient Education*

  • Offer structured education to every person and/or their carer at and around the time of diagnosis, with annual reinforcement and review. Inform people and their carers that structured education is an integral part of diabetes care.
  • Select a patient-education programme that meets the criteria laid down by the Department of Health and Diabetes UK Patient Education Working Group**.
    • Any programme should be evidence-based and suit the needs of the individual. The programme should have specific aims and learning objectives, and should support development of self-management attitudes, beliefs, knowledge and skills for the learner, their family and carers.
    • The programme should have a structured curriculum that is theory driven and evidence-based, resource-effective, has supporting materials, and is written down.
    • The programme should be delivered by trained educators who have an understanding of education theory appropriate to the age and needs of the programme learners, and are trained and competent in delivery of the principles and content of the programme they are offering.
    • The programme itself should be quality assured, and be reviewed by trained, competent, independent assessors who assess it against key criteria to ensure sustained consistency.
    • The outcomes from the programme should be regularly audited.
  • Ensure the patient-education programme provides the necessary resources to support the educators, and that educators are properly trained and given time to develop and maintain their skills.
  • Offer group education programmes as the preferred option. Provide an alternative of equal standard for a person unable or unwilling to participate in group education.
  • Ensure the patient-education programmes available meet the cultural, linguistic, cognitive and literacy needs in the locality.
  • Ensure all members of the diabetes healthcare team are familiar with the programmes of patient education available locally, that these programmes are integrated with the rest of the care pathway, and that people with diabetes and their carers have the opportunity to contribute to the design and provision of local programmes.

*The recommendations in this section replace 'Guidance on the use of patient-education models for diabetes' (NICE technology appraisal guidance 60).

**Structured patient education in diabetes: report from the patient education working group. Available from: www.dh.gov.uk External Web Site Policy.

Lifestyle Management/Non-Pharmacological Management

Neither the management of obesity nor smoking cessation is specifically addressed in this guideline. Follow other NICE guidance in these areas (see section 6 of the original guideline document for further details).

Dietary Advice

  • Provide individualised and ongoing nutritional advice from a healthcare professional with specific expertise and competencies in nutrition.
  • Provide dietary advice in a form sensitive to the individual's needs, culture and beliefs, being sensitive to their willingness to change and the effects on their quality of life.
  • Emphasise advice on healthy balanced eating that is applicable to the general population when providing advice to people with type 2 diabetes. Encourage high-fibre, low-glycaemic-index sources of carbohydrate in the diet, such as fruit, vegetables, wholegrains and pulses; include low-fat dairy products and oily fish; and control the intake of foods containing saturated and trans fatty acids.
  • Integrate dietary advice with a personalised diabetes management plan, including other aspects of lifestyle modification, such as increasing physical activity and losing weight.
  • Target, for people who are overweight, an initial body weight loss of 5-10%, while remembering that lesser degrees of weight loss may still be of benefit and that larger degrees of weight loss in the longer term will have advantageous metabolic impact.
  • Individualise recommendations for carbohydrate and alcohol intake, and meal patterns. Reducing the risk of hypoglycaemia should be a particular aim for a person using insulin or an insulin secretagogue.
  • Advise individuals that limited substitution of sucrose-containing foods for other carbohydrate in the meal plan is allowable, but that care should be taken to avoid excess energy intake.
  • Discourage the use of foods marketed specifically for people with diabetes.
  • When patients are admitted to hospital as inpatients or to any other institutions, implement a meal-planning system that provides consistency in the carbohydrate content of meals and snacks.

Management of Depression

  • Follow the recommendations in 'Depression: management of depression in primary and secondary care' (NICE clinical guideline 23 External Web Site Policy).

Glucose Control Levels

  • When setting a target glycated haemoglobin (HbA1c):
    • Involve the person in decisions about their individual HbA1c target level, which may be above that of 6.5% set for people with type 2 diabetes in general
    • Encourage the person to maintain their individual target unless the resulting side effects (including hypoglycaemia) or their efforts to achieve this impair their quality of life
    • Offer therapy (lifestyle and medication) to help achieve and maintain the HbA1c target level
    • Inform a person with a higher HbA1c that any reduction in HbA1c towards the agreed target is advantageous to future health
    • Avoid pursuing highly intensive management to levels of less than 6.5%.
  • Measure the individual's HbA1c levels at:
    • 2-6-monthly intervals (tailored to individual needs) until the blood glucose level is stable on unchanging therapy; use a measurement made at an interval of less than 3 months as a indicator of direction of change, rather than as a new steady state
    • 6-monthly intervals once the blood glucose level and blood glucose-lowering therapy are stable.
  • If HbA1c levels remain above target levels, but pre-meal self-monitoring levels remain well controlled (< 7.0 mmol/litre), consider self-monitoring to detect postprandial hyperglycaemia (> 8.5 mmol/litre) and manage to below this level if detected (see sections on glucose control therapy below).
  • Measure HbA1c using high-precision methods and report results in units aligned with those used in the DCCT trial* (or as recommended by national agreement after publication of this guideline).
  • When HbA1c monitoring is invalid (because of disturbed erythrocyte turnover or abnormal haemoglobin type), estimate trends in blood glucose control using one of the following:
    • Fructosamine estimation
    • Quality-controlled plasma glucose profiles
    • Total glycated haemoglobin estimation (if abnormal haemoglobins)
  • Investigate unexplained discrepancies between HbA1c and other glucose measurements. Seek advice from a team with specialist expertise in diabetes or clinical biochemistry.

*Little RR, Rohlfing CL, Wiedmeyer HM, et al. (2001). The National Glycohemoglobin Standardization Program (NGSP): a five-year progress report. Clinical Chemistry 47:1985–1992.

Self-Monitoring of Plasma Glucose

  • Offer self-monitoring of plasma glucose to a person newly diagnosed with type 2 diabetes only as an integral part of his or her self-management education. Discuss its purpose and agree how it should be interpreted and acted upon.
  • Self-monitoring of plasma glucose should be available:
    • To those on insulin treatment
    • To those on oral glucose-lowering medications to provide information on hypoglycaemia
    • To assess changes in glucose control resulting from medications and lifestyle changes
    • To monitor changes during intercurrent illness
    • To ensure safety during activities, including driving
  • Assess at least annually and in a structured way:
    • Self-monitoring skills
    • The quality and appropriate frequency of testing
    • The use made of the results obtained
    • The impact on quality of life
    • The continued benefit
    • The equipment used
  • If self-monitoring is appropriate but blood glucose monitoring is unacceptable to the individual, discuss the use of urine glucose monitoring.

Oral Glucose Control Therapies (1): Metformin, Insulin Secretagogues and Acarbose

Metformin

  • Start metformin treatment in a person who is overweight or obese (tailoring the assessment of body-weight-associated risk according to ethnic group*) and whose blood glucose is inadequately controlled (see under "Glucose Control Levels" above) by lifestyle interventions (nutrition and exercise) alone.
  • Consider metformin as an option for first-line glucose-lowering therapy for a person who is not overweight.
  • Continue with metformin if blood glucose control remains or becomes inadequate (see under "Glucose Control Levels" above) and another oral glucose-lowering medication (usually a sulfonylurea) is added.
  • Step up metformin therapy gradually over weeks to minimise risk of gastro-intestinal (GI) side effects. Consider a trial of extended-absorption metformin tablets where GI tolerability prevents continuation of metformin therapy.
  • Review the dose of metformin if the serum creatinine exceeds 130 micromol/litre or the estimated glomerular filtration rate (eGFR) is below 45 mL/minute/1.73-m2.
    • Stop the metformin if the serum creatinine exceeds 150 micromol/litre or the eGFR is below 30 mL/minute/1.73-m2.
    • Prescribe metformin with caution for those at risk of a sudden deterioration in kidney function and those at risk of eGFR falling below 45 mL/minute/1.73-m2.
  • The benefits of metformin therapy should be discussed with a person with mild to moderate liver dysfunction or cardiac impairment so that:
    • Due consideration can be given to the cardiovascular-protective effects of the drug.
    • An informed decision can be made on whether to continue or stop the metformin.

*See the National Guideline Clearinghouse (NGC) summary of the National Institute of Health and Clinical Excellence (NICE) clinical guideline; no 43 'Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children.'

Insulin Secretagogues

  • Consider a sulfonylurea as an option for first-line glucose-lowering therapy if:
    • The person is not overweight
    • The person does not tolerate metformin (or it is contraindicated)

      or

    • A rapid response to therapy is required because of hyperglycaemic symptoms
  • Add a sulfonylurea as second-line therapy when blood glucose control remains or becomes inadequate (see "Glucose Control Levels" above) with metformin.
  • Continue with a sulfonylurea if blood glucose control remains or becomes inadequate (see "Glucose Control Levels" above) and another oral glucose-lowering medication is added.
  • Prescribe a sulfonylurea with a low acquisition cost (but not glibenclamide) when an insulin secretagogue is indicated (see above).
  • When drug concordance is a problem, offer a once-daily, long-acting sulfonylurea.
  • Educate a person being treated with an insulin secretagogue, particularly if renally impaired, about the risk of hypoglycaemia.

Rapid-Acting Insulin Secretagogues

  • Consider offering a rapid-acting insulin secretagogue to a person with an erratic lifestyle.

Acarbose

  • Consider acarbose for a person unable to use other oral glucose-lowering medications.

Oral Glucose Control Therapies (2): Other Oral Agents and Exenatide

The recommendations in this section were updated by the short clinical guideline 'Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes' (www.nice.org.uk/CG87shortguideline External Web Site Policy). The guideline gives details of the methods and the evidence used to develop the recommendations.

Dipeptidyl peptidase-4 (DPP-4) Inhibitors (Sitagliptin, Vildagliptin)

  • Consider adding a DPP-4 inhibitor (sitagliptin, vildagliptin) instead of a sulfonylurea as second-line therapy to first-line metformin when control of blood glucose remains or becomes inadequate (HbA1c > 6.5%, or other higher level agreed with the individual) if:
    • The person is at significant risk of hypoglycaemia or its consequences (e.g., older people and people in certain jobs [e.g., those working at heights or with heavy machinery] or people in certain social circumstances [for example, those living alone]).
    • The person does not tolerate a sulfonylurea or a sulfonylurea is contraindicated. [new 2009]
  • Consider adding a DPP-4 inhibitor (sitagliptin, vildagliptin) as second-line therapy to first-line sulfonylurea monotherapy when control of blood glucose remains or becomes inadequate (HbA1c > 6.5%, or other higher level agreed with the individual) if:
    • The person does not tolerate metformin, or metformin is contraindicated. [new 2009]
  • Consider adding sitagliptin* as third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥7.5% or other higher level agreed with the individual) and insulin is unacceptable or inappropriate**. [new 2009]
  • Only continue DPP-4 inhibitor therapy (sitagliptin, vildagliptin) if the person has had a beneficial metabolic response (a reduction of at least 0.5 percentage points in HbA1c in 6 months). [new 2009]
  • Discuss the potential benefits and risks of treatment with a DPP-4 inhibitor (sitagliptin, vildagliptin) with the person to enable them to make an informed decision.

    A DPP-4 inhibitor (sitagliptin, vildagliptin) may be preferable to a thiazolidinedione (pioglitazone, rosiglitazone) if:

    • Further weight gain would cause or exacerbate significant problems associated with a high body weight.
    • A thiazolidinedione (pioglitazone, rosiglitazone) is contraindicated.
    • The person has previously had a poor response to, or did not tolerate, a thiazolidinedione (pioglitazone, rosiglitazone).

    There may be some people for whom either a DPP-4 inhibitor (sitagliptin, vildagliptin) or a thiazolidinedione (pioglitazone, rosiglitazone) may be suitable and, in this case, the choice of treatment should be based on patient preference. [new 2009]

*At the time of publication, sitagliptin was the only DPP-4 inhibitor with UK marketing authorisation for use in this combination.

**Because of employment, social or recreational issues related to putative hypoglycaemia, injection anxieties, other personal issues or obesity.

Thiazolidinediones (Pioglitazone, Rosiglitazone)*

  • Consider adding a thiazolidinedione (pioglitazone, rosiglitazone) instead of a sulfonylurea as second-line therapy to first-line metformin when control of blood glucose remains or becomes inadequate (HbA1c ≥6.5%, or other higher level agreed with the individual) if:
    • The person is at significant risk of hypoglycaemia or its consequences (for example, older people and people in certain jobs [for example, those working at heights or with heavy machinery] or people in certain social circumstances [for example, those living alone])
    • A person does not tolerate a sulfonylurea or a sulfonylurea is contraindicated. [new 2009]
  • Consider adding a thiazolidinedione (pioglitazone, rosiglitazone) as second-line therapy to first-line sulfonylurea monotherapy when control of blood glucose remains or becomes inadequate (HbA1c ≥6.5%, or other higher level agreed with the individual) if:
    • The person does not tolerate metformin or metformin is contraindicated. [new 2009]
  • Consider adding a thiazolidinedione (pioglitazone, rosiglitazone) as third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥7.5%, or other higher level agreed with the individual) and insulin is unacceptable or inappropriate**. [new 2009]
  • Do not commence or continue a thiazolidinedione (pioglitazone, rosiglitazone) in people who have heart failure, or who are at higher risk of fracture. [new 2009]
  • When selecting a thiazolidinedione (pioglitazone, rosiglitazone), take into account up-to-date advice from the relevant regulatory bodies (the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency), cost, safety and prescribing issues (see below). [new 2009]
  • Only continue thiazolidinedione therapy (pioglitazone, rosiglitazone) if the person has had a beneficial metabolic response (a reduction of at least 0.5 percentage points in HbA1c in 6 months). [new 2009]
  • Consider combining pioglitazone with insulin therapy*** for a person:
    • Who has previously had a marked glucose-lowering response to thiazolidinedione therapy (pioglitazone, rosiglitazone)
    • Who is on high-dose insulin therapy and whose blood glucose is inadequately controlled [new 2009]
  • Discuss the potential benefits and risks of treatment with a thiazolidinedione (pioglitazone, rosiglitazone) with the person to enable them to make an informed decision.

    A thiazolidinedione (pioglitazone, rosiglitazone) may be preferable to a DPP-4 inhibitor (sitagliptin, vildagliptin) if:

    • The person has marked insulin insensitivity
    • A DPP-4 inhibitor (sitagliptin, vildagliptin) is contraindicated
    • The person has previously had a poor response to, or did not tolerate, a DPP-4 inhibitor (sitagliptin, vildagliptin).

    There may be some people for whom either a thiazolidinedione (pioglitazone, rosiglitazone) or a DPP-4 inhibitor (sitagliptin, vildagliptin) may be suitable and, in this case, the choice of treatment should be based on patient preference. [new 2009]

*The recommendations in this section replace 'Guidance on the use of glitazones for the treatment of type 2 diabetes' (NICE technology appraisal guidance 63).

**Because of employment, social or recreational issues related to putative hypoglycaemia, injection anxieties, other personal issues or obesity.

***At the time of publication pioglitazone was the only thiazolidinedione with UK marketing authorisation for use with insulin.

Glucagon-like peptide-1 (GLP-1) Mimetic (Exenatide)

  • Consider adding a GLP-1 mimetic (exenatide) as third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥7.5%, or other higher level agreed with the individual), and the person has:
    • A body mass index (BMI) ≥35.0 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight
    • A BMI < 35.0 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities. [new 2009]
  • Only continue GLP-1 mimetic (exenatide) therapy if the person has had a beneficial metabolic response (a reduction of at least 1.0 percentage point in HbA1c and a weight loss of at least 3% of initial body weight at 6 months). [new 2009]
  • Discuss the potential benefits and risks of treatment with a GLP-1 mimetic (exenatide) with the person to enable them to make an informed decision. [new 2009]

Glucose Control: Insulin Therapy

Oral Agent Combination Therapy with Insulin

  • When starting basal insulin therapy:
    • Continue with metformin and the sulfonylurea (and acarbose, if used)
    • Review the use of the sulfonylurea if hypoglycaemia occurs
  • When starting pre-mixed insulin therapy (or mealtime plus basal insulin regimens):
    • Continue with metformin
    • Continue the sulfonylurea initially, but review and discontinue if hypoglycaemia occurs

Insulin Therapy

The recommendations in this section were updated by the short clinical guideline 'Type 2 diabetes newer agents for blood glucose control in type 2 diabetes' (www.nice.org.uk/CG87shortguideline External Web Site Policy). The guideline gives details of the methods and the evidence used to develop the recommendations.

  • Discuss the benefits and risks of insulin therapy when control of blood glucose remains or becomes inadequate (HbA1c ≥7.5% or other higher level agreed with the individual) with other measures. Start insulin therapy if the person agrees. [new 2009]
  • For a person on dual therapy who is markedly hyperglycaemic, consider starting insulin therapy in preference to adding other drugs to control blood glucose unless there is strong justification* not to. [new 2009]
  • When starting insulin therapy, use a structured programme employing active insulin dose titration that encompasses:
    • Structured education
    • Continuing telephone support
    • Frequent self-monitoring
    • Dose titration to target
    • Dietary understanding
    • Management of hypoglycaemia
    • Management of acute changes in plasma glucose control
    • Support from an appropriately trained and experienced healthcare professional
  • Initiate insulin therapy from a choice of a number of insulin types and regimens.
    • Begin with human NPH insulin injected at bed-time or twice daily according to need.
    • Consider, as an alternative, using a long-acting insulin analogue (insulin detemir, insulin glargine) if:
      • The person needs assistance from a carer or healthcare professional to inject insulin, and use of a long-acting insulin analogue (insulin detemir, insulin glargine) would reduce the frequency of injections from twice to once daily
      • The person's lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes
      • The person would otherwise need twice-daily NPH insulin injections in combination with oral glucose-lowering drugs
      • The person cannot use the device to inject NPH insulin
    • Consider twice-daily pre-mixed (biphasic) human insulin (particularly if HbA1c ≥9.0%). A once-daily regimen may be an option.
    • Consider pre-mixed preparations that include short-acting insulin analogues, rather than pre-mixed preparations that include short-acting human insulin preparations, if:
      • A person prefers injecting insulin immediately before a meal
      • Hypoglycaemia is a problem
      • Blood glucose levels rise markedly after meals [new 2009]
  • Consider switching to a long-acting insulin analogue (insulin detemir, insulin glargine) from NPH insulin in people:
    • Who do not reach their target HbA1c because of significant hypoglycaemia
    • Who experience significant hypoglycaemia on NPH insulin irrespective of the level of HbA1c reached
    • Who cannot use the device needed to inject NPH insulin but who could administer their own insulin safely and accurately if a switch to a long-acting insulin analogue were made
    • Who need help from a carer or healthcare professional to administer insulin injections and for whom switching to a long-acting insulin analogue would reduce the number of daily injections. [new 2009]
  • Monitor a person on a basal insulin regimen (NPH insulin or a long-acting insulin analogue [insulin detemir, insulin glargine]) for the need for short-acting insulin before meals (or a pre-mixed insulin preparation). [new 2009]
  • Monitor a person who is using pre-mixed insulin once or twice daily for the need for a further injection of short-acting insulin before meals or for a change to a regimen of mealtime plus basal insulin, based on NPH insulin or long-acting insulin analogues (insulin detemir, insulin glargine), if blood glucose control remains inadequate. [new 2009]

*Because of employment, social or recreational issues related to putative hypoglycaemia, injection anxieties, other personal issues or obesity.

Insulin Delivery Devices

  • Offer education to a person who requires insulin about using an injection device (usually a pen injector and cartridge or a disposable pen) that they and/or their carer find easy to use.
  • Appropriate local arrangements should be in place for the disposal of sharps.
  • If a person has a manual or visual disability and requires insulin, offer a device or adaptation that:
    • Takes into account his or her individual needs
    • He or she can use successfully

Blood Pressure Therapy

  • Measure blood pressure at least annually in a person without previously diagnosed hypertension or renal disease. Offer and reinforce preventive lifestyle advice.
  • For a person on antihypertensive therapy at diagnosis of diabetes, review control of blood pressure and medications used, and make changes only where there is poor control or where current medications are not appropriate because of microvascular complications or metabolic problems.
  • Repeat blood pressure (BP) measurements within:
    • 1 month if BP is higher than 150/90 mmHg
    • 2 months if BP is higher than 140/80 mmHg
    • 2 months if BP is higher than 130/80 mmHg and there is kidney, eye or cerebrovascular damage

    Offer lifestyle advice (diet and exercise) at the same time.

  • Offer lifestyle advice (see dietary recommendations in this guideline and the lifestyle recommendations in section 1.2 of Hypertension: management of hypertension in adults in primary care External Web Site Policy [NICE clinical guideline 34]) if blood pressure is confirmed as being consistently above 140/80 mmHg (or above 130/80 mmHg if there is kidney, eye or cerebrovascular damage).
  • Add medications if lifestyle advice does not reduce blood pressure to below 140/80 mmHg (below 130/80 mmHg if there is kidney, eye or cerebrovascular damage).
  • Monitor blood pressure 1-2 monthly, and intensify therapy if on medications until blood pressure is consistently below 140/80 mmHg (below 130/80 mmHg if there is kidney, eye or cerebrovascular disease).
  • First-line blood-pressure-lowering therapy should be a once-daily, generic angiotensin-converting enzyme (ACE) inhibitor. Exceptions to this are people of African-Caribbean descent or women for whom there is a possibility of becoming pregnant.
  • First-line blood-pressure-lowering therapy for a person of African-Caribbean descent should be an ACE inhibitor plus either a diuretic or a generic calcium-channel antagonist (calcium-channel blocker).
  • A calcium-channel blocker should be the first-line blood-pressure-lowering therapy for a woman for whom, after an informed discussion, it is agreed there is a possibility of her becoming pregnant.
  • For a person with continuing intolerance to an ACE inhibitor (other than renal deterioration or hyperkalaemia), substitute an angiotensin II-receptor antagonist for the ACE inhibitor.
  • If the person's blood pressure is not reduced to the individually agreed target with first-line therapy, add a calcium-channel blocker or a diuretic (usually bendroflumethiazide, 2.5 mg daily). Add the other drug (that is, the calcium-channel blocker or diuretic) if the target is not reached with dual therapy.
  • If the person's blood pressure is not reduced to the individually agreed target with triple therapy, add an alpha-blocker, a beta-blocker or a potassium-sparing diuretic (the last with caution if the individual is already taking an ACE inhibitor or an angiotensin II-receptor antagonist).
  • Monitor the blood pressure of a person who has attained and consistently remained at his or her blood pressure target every 4-6 months, and check for possible adverse effects of antihypertensive therapy – including the risks from unnecessarily low blood pressure.

Cardiovascular Risk Estimation

  • Consider a person to be at high premature cardiovascular risk for his or her age unless he or she:
    • Is not overweight, tailoring this with an assessment of body-weight-associated risk according to ethnic group*
    • Is normotensive (< 140/80 mmHg in the absence of antihypertensive therapy)
    • Does not have microalbuminuria
    • Does not smoke
    • Does not have a high-risk lipid profile
    • Has no history of cardiovascular disease and
    • Has no family history of cardiovascular disease
  • If the person is considered not to be at high cardiovascular risk, estimate cardiovascular risk annually using the UK Prospective Diabetes Study (UKPDS) risk engine (see www.dtu.ox.ac.uk/index.php?maindoc=/riskengine/ External Web Site Policy).
  • Consider using cardiovascular risk estimates from the UKPDS risk engine (see above recommendation) for educational purposes when discussing cardiovascular complications with the individual.
  • Perform a full lipid profile (including high-density lipoprotein [HDL] cholesterol and triglyceride estimations) when assessing cardiovascular risk after diagnosis and annually, and before starting lipid-modifying therapy.

*See the NICE guideline 'Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children.'

Management of Blood Lipid Levels

Statins and Ezetimibe

  • Review cardiovascular risk status annually by assessment of cardiovascular risk factors, including features of the metabolic syndrome and waist circumference, and change in personal or family cardiovascular history.
  • For a person who is 40 years old or over:
    • Initiate therapy with generic simvastatin (to 40 mg) or a statin of similar efficacy and cost unless the cardiovascular risk from non-hyperglycaemia-related factors is low (see previous section under "Cardiovascular Risk Estimation")
    • If the cardiovascular risk from non-hyperglycaemia-related factors is low, assess cardiovascular risk using the UKPDS risk engine (see previous section under "Cardiovascular Risk Estimation") and initiate simvastatin therapy (to 40 mg), or a statin of similar efficacy and cost, if the cardiovascular risk exceeds 20% over 10 years.
  • For a person who is under 40 years old, consider initiating generic simvastatin therapy (to 40 mg), or a statin of similar efficacy and cost, where the cardiovascular risk factor profile appears particularly poor (multiple features of the metabolic syndrome, presence of conventional risk factors, microalbuminuria, at-risk ethnic group, or strong family history of premature cardiovascular disease).
  • Once a person has been started on cholesterol-lowering therapy, assess his or her lipid profile (together with other modifiable risk factors and any new diagnosis of cardiovascular disease) 1–3 months after starting treatment, and annually thereafter. In those not on cholesterol-lowering therapy, reassess cardiovascular risk annually and consider initiating a statin.
  • Increase the dose of simvastatin, in anyone initiated on simvastatin in line with the above recommendations, to 80 mg daily unless total cholesterol level is below 4.0 mmol/litre or low-density lipoprotein [LDL] cholesterol level is below 2.0 mmol/litre.
  • Consider intensifying cholesterol-lowering therapy (with a more effective statin or ezetimibe in line with NICE guidance)* if there is existing or newly diagnosed cardiovascular disease, or if there is an increased albumin excretion rate, to achieve a total cholesterol level below 4.0 mmol/litre (and HDL cholesterol not exceeding 1.4 mmol/litre) or an LDL cholesterol level below 2.0 mmol/litre.
  • If there is a possibility of a woman becoming pregnant, do not use statins unless the issues have been discussed with the woman and agreement has been reached.

*See the National Institute of Health and Clinical Excellence (NICE) technology appraisals 'Statins for the prevention of cardiovascular events' and 'Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia'.

Fibrates

  • If there is a history of elevated serum triglycerides, perform a full fasting lipid profile (including HDL cholesterol and triglyceride estimations) when assessing cardiovascular risk annually.
  • Assess possible secondary causes of high serum triglyceride levels, including poor blood glucose control (others include hypothyroidism, renal impairment and liver inflammation, particularly from alcohol). If a secondary cause is identified, manage according to need.
  • Prescribe a fibrate (fenofibrate as first-line) if triglyceride levels remain above 4.5 mmol/litre despite attention to other causes. In some circumstances, this will be before a statin has been started because of acute need (that is, risk of pancreatitis) and because of the undesirability of initiating two drugs at the same time.
  • If cardiovascular risk is high (as is usual in people with type 2 diabetes), consider adding a fibrate to statin therapy if triglyceride levels remain in the range 2.3–4.5 mmol/litre despite statin therapy.

Nicotinic Acid

  • Do not use nicotinic acid preparations and derivatives routinely for people with type 2 diabetes. They may have a role in a few people who are intolerant of other therapies and have more extreme disorders of blood lipid metabolism, when managed by those with specialist expertise in this area.

Omega-3 Fish Oils

  • Do not prescribe fish oil preparations for the primary prevention of cardiovascular disease in people with type 2 diabetes. This recommendation does not apply to people with hypertriglyceridaemia receiving advice from a healthcare professional with special expertise in blood lipid management.
  • Consider a trial of highly concentrated, licensed omega-3 fish oils for refractory hypertriglyceridaemia if lifestyle measures and fibrate therapy have failed.

Anti-Thrombotic Therapy

  • Offer low-dose aspirin, 75 mg daily, to a person who is 50 years old or over, if blood pressure is below 145/90 mmHg.
  • Offer low-dose aspirin, 75 mg daily, to a person who is under 50 years old and has significant other cardiovascular risk factors (features of the metabolic syndrome, strong early family history of cardiovascular disease, smoking, hypertension, extant cardiovascular disease, microalbuminuria).
  • Clopidogrel should be used instead of aspirin only in those with clear aspirin intolerance (except in the context of acute cardiovascular events and procedures). Follow the recommendations in.

Kidney Damage

  • Ask all people with or without detected nephropathy to bring in a first-pass morning urine specimen once a year. In the absence of proteinuria/urinary tract infection (UTI), send this for laboratory estimation of albumin:creatinine ratio. Request a specimen on a subsequent visit if UTI prevents analysis.
  • Make the measurement on a spot sample if a first-pass sample is not provided (and repeat on a first-pass specimen if abnormal) or make a formal arrangement for a first-pass specimen to be provided.
  • Measure serum creatinine and estimate the glomerular filtration rate (using the method-abbreviated modification of diet in renal disease [MDRD] four-variable equation) annually at the time of albumin:creatinine ratio estimation.
  • Repeat the test if an abnormal albumin:creatinine ratio (ACR) is obtained (in the absence of proteinuria/UTI) at each of the next two clinic visits but within a maximum of 3-4 months. Take the result to be confirming microalbuminuria if a further specimen (out of two more) is also abnormal (> 2.5 mg/mmol for men, > 3.5 mg/mmol for women).
  • Suspect renal disease other than diabetic nephropathy and consider further investigation or referral when the ACR is raised and any of the following apply:
    • There is no significant or progressive retinopathy
    • Blood pressure is particularly high or resistant to treatment
    • The person previously had a documented normal ACR and develops heavy proteinuria (ACR > 100 mg/mmol)
    • Significant haematuria is present
    • The glomerular filtration rate has worsened rapidly
    • The person is systemically ill
  • Discuss the significance of a finding of abnormal albumin excretion rate, and its trend over time, with the individual concerned.
  • Start ACE inhibitors with the usual precautions and titrate to full dose in all individuals with confirmed raised albumin excretion rate (> 2.5 mg/mmol for men, > 3.5 mg/mmol for women).
  • Have an informed discussion before starting an ACE inhibitor in a woman for whom there is a possibility of pregnancy, assessing the relative risks and benefits of the use of the ACE inhibitor.
  • Substitute an angiotensin II-receptor antagonist for an ACE inhibitor for a person with an abnormal albumin:creatinine ratio if an ACE inhibitor is poorly tolerated.
  • For a person with an abnormal albumin:creatinine ratio, maintain blood pressure below 130/80 mmHg.
  • Agree referral criteria for specialist renal care between local diabetes specialists and nephrologists.

Eye Damage

  • Arrange or perform eye screening at or around the time of diagnosis. Arrange repeat of structured eye surveillance annually.
  • Explain the reasons for, and success of, eye surveillance systems to the individual and ensure attendance is not reduced by ignorance of need or fear of outcome.
  • Use mydriasis with tropicamide when photographing the retina, after prior informed agreement following discussion of the advantages and disadvantages. Discussions should include precautions for driving.
  • Use a quality-assured digital retinal photography programme using appropriately trained staff.
  • Perform visual acuity testing as a routine part of eye surveillance programmes.
  • Repeat structured eye surveillance according to the findings by:
    • Routine review in 1 year
    • Earlier review
    • Referral to an ophthalmologist
  • Arrange emergency review by an ophthalmologist for:
    • Sudden loss of vision
    • Rubeosis iridis
    • Pre-retinal or vitreous haemorrhage
    • Retinal detachment
  • Arrange rapid review by an ophthalmologist for new vessel formation.
  • Refer to an ophthalmologist in accordance with the National Screening Committee criteria and timelines if any of these features is present:
    • Referable maculopathy:
      • Exudate or retinal thickening within one disc diameter of the centre of the fovea
      • Circinate or group of exudates within the macula (the macula is defined here as a circle centred on the fovea, with a diameter the distance between the temporal border of the optic disc and the fovea)
      • Any microaneurysm or haemorrhage within one disc diameter of the centre of the fovea, only if associated with deterioration of best visual acuity to 6/12 or worse
    • Referable pre-proliferative retinopathy (if cotton wool spots are present, look carefully for the following features, but cotton wool spots themselves do not define pre-proliferative retinopathy):
      • Any venous beading
      • Any venous loop or reduplication
      • Any intraretinal microvascular abnormalities
      • Multiple deep, round or blot haemorrhages
    • Any unexplained drop in visual acuity

Nerve Damage

  • For the management of foot problems relating to type 2 diabetes, follow recommendations in this NICE guideline.

Diabetic Neuropathic Pain Management

  • Make a formal enquiry annually about the development of neuropathic symptoms causing distress.
    • Discuss the cause and prognosis (including possible medium-term remission) of troublesome neuropathic symptoms, if present (bearing in mind alternative diagnoses).
    • Agree appropriate therapeutic options and review understanding at each clinical contact.
  • Be alert to the psychological consequences of chronic, painful diabetic neuropathy and offer psychological support according to the needs of the individual.
  • Use a tricyclic drug to treat neuropathic discomfort (start with low doses, titrated as tolerated) if standard analgesic measures have not worked, timing the medication to be taken before the time of day when the symptoms are troublesome; advise that this is a trial of therapy.
  • Offer a trial of duloxetine, gabapentin or pregabalin if a trial of tricyclic drug does not provide effective pain relief. The choice of drug should be determined by current drug prices. Trials of these therapies should be stopped if the maximally tolerated drug dose is ineffective. If side effects limit effective dose titration, try another one of the drugs.
  • Consider a trial of opiate analgesia if severe chronic pain persists despite trials of other measures. If there is inadequate relief of the pain associated with diabetic neuropathic symptoms, seek the assistance of a chronic pain management service following a discussion with the person concerned.
  • If drug management of diabetic neuropathic pain has been successful, consider reducing the dose and stopping therapy following discussion and agreement with the individual.
  • If neuropathic symptoms cannot be controlled adequately, it may be helpful to further discuss:
    • The reasons for the problem
    • The likelihood of remission in the medium term
    • The role of improved blood glucose control

Gastroparesis

  • Consider the diagnosis of gastroparesis in an adult with erratic blood glucose control or unexplained gastric bloating or vomiting, taking into consideration possible alternative diagnoses.
  • Consider a trial of metoclopramide, domperidone or erythromycin for an adult with gastroparesis.
  • If gastroparesis is suspected, consider referral to specialist services if:
    • The differential diagnosis is in doubt
    • Persistent or severe vomiting occurs

Erectile Dysfunction

  • Review the issue of erectile dysfunction with men annually
  • Provide assessment and education for men with erectile dysfunction to address contributory factors and treatment options.
  • Offer a phosphodiesterase-5 inhibitor (choosing the drug with the lowest acquisition cost), in the absence of contraindications, if erectile dysfunction is a problem.
  • Following discussion, refer to a service offering other medical, surgical, or psychological management of erectile dysfunction if phosphodiesterase-5 inhibitors have been unsuccessful.

Other Aspects of Autonomic Neuropathy

  • Consider the possibility of contributory sympathetic nervous system damage for a person who loses the warning signs of hypoglycaemia.
  • Consider the possibility of autonomic neuropathy affecting the gut in an adult with unexplained diarrhoea, particularly at night.
  • When using tricyclic drugs and antihypertensive medications in people with autonomic neuropathy, be aware of the increased likelihood of side effects such as orthostatic hypotension.
  • Investigate a person with unexplained bladder-emptying problems for the possibility of autonomic neuropathy affecting the bladder.
  • Include in the management of autonomic neuropathy symptoms the specific interventions indicated by the manifestations (for example, for abnormal sweating or nocturnal diarrhoea).
Clinical Algorithm(s)

The following algorithms are provided in the quick reference guide (see the "Availability of Companion Documents" field):

  • Blood-glucose-lowering therapy
  • Management of blood lipids
  • Anti-thrombotic therapy
  • Blood pressure management
  • Neuropathic pain management

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of evidence supporting the recommendations is not specifically stated.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of type 2 diabetes to reduce morbidity and improve quality of life

Potential Harms

Side effects of drug therapy, including hypoglycemia with glucose-lowering therapy (see sections on adverse effects of specific drugs in the full version of the original guideline document)

Contraindications

Contraindications

  • Statins are contraindicated in pregnancy.
  • Rosiglitazone must not be used in patients with acute coronary syndrome, such as angina or some types of myocardial infarction.

Qualifying Statements

Qualifying Statements

  • This guidance represents the view of the National Institute for Health and Clinical Excellence (NICE), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.
  • Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.
  • The guideline has the following limitations:
    • NICE clinical guidelines usually do not cover issues of service delivery, organisation or provision (unless specified in the remit from the Department of Health).
    • NICE is primarily concerned with health services and so recommendations are not provided for social services and the voluntary sector. However, the guideline may address important issues in how National Health Service clinicians interface with these other sectors.
    • Generally, the guideline does not cover rare, complex, complicated or unusual conditions.
    • Where a meta-analysis was available, generally the individual papers contained within were not appraised.
    • It is not possible in the development of a clinical guideline to complete an extensive systematic literature review of all pharmacological toxicity, although NICE expect their guidelines to be read alongside the summaries of product characteristics (SPCs).

Implementation of the Guideline

Description of Implementation Strategy

National Institute for Health and Clinical Excellence (NICE) has developed tools to help organisations implement this guidance (see www.nice.org.uk/CG87 External Web Site Policy).

Key Priorities for Implementation

  • Offer structured education to every person and/or their carer at and around the time of diagnosis, with annual reinforcement and review. Inform people and their carers that structured education is an integral part of diabetes care.
  • Provide individualised and ongoing nutritional advice from a healthcare professional with specific expertise and competencies in nutrition.
  • When setting a target glycated haemoglobin (HbA1c):
    • Involve the person in decisions about their individual HbA1c target level, which may be above that of 6.5% set for people with type 2 diabetes in general
    • Encourage the person to maintain their individual target unless the resulting side effects (including hypoglycaemia) or their efforts to achieve this impair their quality of life
    • Offer therapy (lifestyle and medication) to help achieve and maintain the HbA1c target level
    • Inform a person with a higher HbA1c that any reduction in HbA1c towards the agreed target is advantageous to future health
    • Avoid pursuing highly intensive management to levels of less than 6.5%
  • Offer self-monitoring of plasma glucose to a person newly diagnosed with type 2 diabetes only as an integral part of his or her self-management education. Discuss its purpose and agree how it should be interpreted and acted upon.
  • When starting insulin therapy, use a structured programme employing active insulin dose titration that encompasses:
    • Structured education
    • Continuing telephone support
    • Frequent self-monitoring
    • Dose titration to target
    • Dietary understanding
    • Management of hypoglycaemia
    • Management of acute changes in plasma glucose control
    • Support from an appropriately trained and experienced healthcare professional
Implementation Tools
Audit Criteria/Indicators
Clinical Algorithm
Foreign Language Translations
Patient Resources
Quick Reference Guides/Physician Guides
Resources
Slide Presentation
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)
National Collaborating Centre for Chronic Conditions. Type 2 diabetes. The management of type 2 diabetes. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 May. 49 p. (Clinical guideline; no. 87). 
Adaptation

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

Date Released
2004 Jun 17 (revised 2009 May)
Guideline Developer(s)
National Clinical Guideline Centre for Acute and Chronic Conditions - National Government Agency [Non-U.S.]
Source(s) of Funding

National Institute for Health and Clinical Excellence (NICE)

Guideline Committee

Guideline Development Group

Composition of Group That Authored the Guideline

Committee Members: Mrs Lina Bakhshi, Information Scientist, NCC-CC; Ms Margaret Bannister, Nurse Consultant in Diabetes Care; Mrs Katherine Cullen, Health Economist, NCC-CC, and Research Fellow, Queen Mary University of London; Professor Melanie Davies, Professor of Diabetes Medicine, University of Leicester; Dr Jose Diaz, Health Services Research Fellow in Guideline Development, NCC-CC; Mrs Barbara Elster, Patient and Carer Representative, Essex; Dr Roger Gadsby, General Practitioner and Senior Lecturer in Primary Care, Warwickshire; Dr Anupam Garrib, Health Services Research Fellow in Guideline Development, NCC-CC; Ms Irene Gummerson, Primary Care Pharmacist, Yorkshire; Dr Martin Hadley-Brown, General Practitioner (trainer), University of Cambridge; Professor Philip Home (Clinical Adviser to the GDG), Professor of Diabetes Medicine, Newcastle University; Mrs Kathryn Leivesley, Practice Nurse, North Manchester Primary Care Trust; Professor Jonathan Mant (Chair), Professor of Primary Care Stroke Research, University of Birmingham; Mrs Emma Marcus, Clinical Specialist Diabetes Dietitian, Hinckley and Bosworth Primary Care Trust; Mr Leo Nherera, Health Economist, National Collaborating Centre for Women’s and Children’s Health; Ms Roberta Richey, Health Services Research Fellow in Guideline Development, NCC-CC; Mr John Roberts, Patient and Carer Representative, Merseyside; Dr Mark Savage, Consultant Physician, North Manchester General Hospital; Dr Stuart Smellie, Consultant Chemical Pathologist, Bishop Auckland General Hospital; Ms Nicole Stack, Guideline Development Project Manager, NCC-CC; Ms Claire Turner, Guideline Development Project Manager, NCC-CC; Ms Susan Varney, Health Services Research Fellow in Guideline Development, NCC-CC; Dr Jiten Vora, Consultant Physician Endocrinologist, Royal Liverpool and Broadgreen University Hospitals

Financial Disclosures/Conflicts of Interest

Members of the Guideline Development Group declared any interests in accordance with the National Institute for Health and Clinical Excellence technical manual.  A register is given in appendix D of the full version of the original guideline, available online at Royal College of Physicians Web site External Web Site Policy.

Guideline Status

This is the current release of the guideline.

This release updates a previously published guideline: National Collaborating Centre for Chronic Conditions. Type 2 diabetes. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 May. 44 p. (Clinical guideline; no. 66).

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Clinical Excellence (NICE) Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Type 2 diabetes. National clinical guideline for management in primary and secondary care (update). Full guideline. London (UK): National Institute for Clinical Excellence (NICE); 2008 May 278 p. (Clinical guideline; no. 66). Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Clinical Excellence (NICE) Web site External Web Site Policy.
  • Type 2 diabetes. The management of type 2 diabetes. Quick reference guide. London (UK): National Institute for Health and Clinical Excellence; 2009 May 20 p. (Clinical guideline; no. 87). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • Type 2 diabetes: newer agents. Costing template. London (UK): National Institute for Health and Clinical Excellence; 2009 Oct. Various p. (Clinical guideline; no. 87). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • Type 2 diabetes. Slide set. London (UK): National Institute for Health and Clinical Excellence; 2009 Jun. 13 p. (Clinical guideline; no. 87). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • Type 2 diabetes (clinical criteria). Audit support. London (UK): National Institute for Health and Clinical Excellence; 2009 Aug. 29 p. (Clinical guideline; no. 87). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • Type 2 diabetes (organisational criteria). Audit support. London (UK): National Institute for Health and Clinical Excellence; 2009 Aug. 9 p. (Clinical guideline; no. 87). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
  • The guidelines manual 2007. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 April. Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.
Patient Resources

The following is available:

  • Type 2 diabetes. Understanding NICE guidance - Information for people who use NHS services. London (UK): National Institute for Health and Clinical Excellence; 2009 May 24 p. (Clinical guideline; no. 81). Electronic copies: Available in English External Web Site Policy and Welsh External Web Site Policy in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

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 July 12, 2004. The information was verified by the guideline developer on November 26, 2004. This NGC summary was updated by ECRI Institute on January 25, 2010. This summary was updated by ECRI Institute on May 17, 2010 following the U.S. Food and Drug Administration advisory on Plavix (clopidogrel). 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 November 22, 2011 following the U.S. Food and Drug Administration (FDA) advisory on Trilipix (fenofibric acid). 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

This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

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