NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Type 2 diabetes: the management of type 2 diabetes (update) 1.1 Short title Type 2 diabetes (update) 2 Background a) The National Institute for Health and Clinical Excellence ( NICE or the Institute ) has commissioned the National Collaborating Centre for Chronic Conditions to review recent evidence on the management of type 2 diabetes, and update the existing guidelines Clinical Guidelines for type 2 diabetes: diabetic renal disease: prevention and early management ; Diabetic retinopathy: early management and screening ; Management of blood glucose ; Blood pressure management ; and Lipids management (Royal College of General Practitioners, 2002) for use in the NHS in England and Wales. The updated guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness. This guideline will be relevant only to people with type 2 diabetes, as guidance on the management of type 1 diabetes is available from the NICE guideline Type 1 diabetes in adults. National clinical guideline for diagnosis and management in primary and secondary care (2004), developed by the National Collaborating Centre for Chronic Conditions. b) The Institute s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by the Type 2 diabetes (update): final scope (June 2006) Page 1 of 8
Institute after an NSF has been issued will have the effect of updating the Framework. c) NICE clinical guidelines support the role of healthcare professionals in providing care in partnership with patients, taking account of their individual needs and preferences, and ensuring that patients (and their carers and families, where appropriate) can make informed decisions about their care and treatment. 3 Clinical need for the guideline a) Type 2 diabetes is a common and chronic disease with a high risk of a number of serious complications. About 1.6 million people in England and Wales are currently diagnosed with diabetes. Type 2 diabetes accounts for more than 85% of these cases and many more people may have type 2 diabetes that is as yet undiagnosed. It has been estimated that diabetes may be responsible for at least 5% of healthcare expenditure in the UK and up to 10% of hospital budgets are used for the care of people with diabetes. b) Good management of blood-glucose levels, blood pressure and lipid levels is known to prevent or delay the long-term complications of diabetes such as renal (kidney) disease, retinopathy (eye problems), cardiovascular events (for example heart attack or stroke) and limb amputation. c) Early detection of complications to enable their secondary prevention is important, as is effective management of late complications when they occur. 4 The guideline a) The guideline development process is described in detail in two publications which are available from the NICE website (see Further information ). The guideline development process: an overview for Type 2 diabetes (update): final scope (June 2006) Page 2 of 8
stakeholders, the public and the NHS describes how organisations can become involved in the development of a guideline. The guidelines manual provides advice on the technical aspects of guideline development. b) This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. c) The areas that will be addressed by the guideline are described in the following sections. 4.1 Population 4.1.1 Groups that will be covered a) People with diagnosed type 2 diabetes. 4.1.2 Groups that will not be covered a) Pregnant women with problems related to type 2 diabetes, or gestational diabetes. A separate guideline on diabetes in pregnancy is under development (expected date of publication November 2007). 4.2 Healthcare setting a) The guideline will cover the care of type 2 diabetes in primary, secondary or tertiary care sectors, but will exclude specialist tertiary procedures in areas such as vascular surgery, renal medicine, cardiology and ophthalmology. b) This is an NHS guideline; although it will also be relevant to practice within residential and nursing homes (care homes), social services and the voluntary sector, it will not make recommendations about services exclusive to these sectors. Type 2 diabetes (update): final scope (June 2006) Page 3 of 8
4.3 Clinical management The guideline will include recommendations on the following areas: a) Clinical and self-monitoring (including target values) for: lipid levels blood pressure glucose levels. b) Pharmacological treatments including those for: reducing blood pressure correcting abnormal blood-fat profile (dyslipidaemia) controlling blood glucose preventing vascular disease. Note that guideline recommendations will normally fall within licensed indications; exceptionally, and only where clearly supported by evidence, use outside a licensed indication may be recommended. The guideline will assume that prescribers will use a drug s summary of product characteristics to inform their decisions for individual patients. c) Non-pharmacological management, including: diet self-management education and empowerment, including use of care plans and emergency self-management. Type 2 diabetes (update): final scope (June 2006) Page 4 of 8
d) The guideline will address the early detection, ongoing management (but not in tertiary care) or referral to specialist services, for the following complications: retinopathy including maculopathy renal disease aspects of autonomic neuropathy and painful neuropathy (including erectile dysfunction) depression. e) The guideline will use the internationally accepted diagnostic criteria for type 2 diabetes. The evidence base on diagnosis will not be reviewed as part of the guideline development. f) The guideline will be sensitive to the specific issues affecting, and the clinical needs of, different ethnic groups. g) Complementary therapies may be considered, if they are already in use in the NHS and there is evidence to support their effectiveness. h) The guideline will not cover: prevention and management of foot problems (there is already updated guidance in this area: Type 2 diabetes: prevention and management of foot problems NICE clinical guideline no. 10) primary prevention of type 2 diabetes or screening those problems which do not arise primarily from diabetes in particular patient groups who may also have diabetes. Type 2 diabetes (update): final scope (June 2006) Page 5 of 8
4.4 Status 4.4.1 Scope a) b) This is the final scope. The guideline will incorporate the following NICE technology appraisal: Inhaled insulin for the treatment of diabetes (types 1 and 2) (expected date of publication October 2006). c) The guideline will update the following NICE technology appraisals, but only in relation to type 2 diabetes: Guidance on the use of long-acting insulin analogues for the treatment of diabetes insulin glargine. NICE technology appraisal guidance no. 53 (2002) Guidance on the use of patient-education models for diabetes. NICE technology appraisal guidance no. 60 (2003) Guidance on the use of glitazones for the treatment of type 2 diabetes. NICE technology appraisal guidance no.63 (2003). d) Related NICE public health guidance: Physical activity guidance for the Highways Agency, Local Authorities, primary care, pharmacists, health visitors and community nurses, schools, workplaces, the leisure and fitness industry and sports clubs. Public health programme guidance (expected date of publication September 2007) Smoking cessation services, including the use of pharmacotherapies, in primary care, pharmacies, local authorities and workplaces, with particular reference to manual working groups, pregnant smokers and hard to reach communities. Public Type 2 diabetes (update): final scope (June 2006) Page 6 of 8
health programme guidance (expected date of publication August 2007). e) Related NICE clinical guidelines: Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (expected date of publication December 2007) Diabetes in pregnancy: management of diabetes and its complications from pre-conception to the postnatal period (expected date of publication November 2007) Hypertension: management of hypertension in adults in primary care (partial update of NICE (partial update of CG18) NICE clinical guideline no. 34 (2006) Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children (expected date of publication November 2006) Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults NICE clinical guideline no. 15 (2004, to be reviewed 2008) Type 2 diabetes: prevention and management of foot problems NICE clinical guideline no. 10 (2004). 4.4.2 Guideline The development of the guideline recommendations will begin in June 2006. Type 2 diabetes (update): final scope (June 2006) Page 7 of 8
5 Further information Information on the guideline development process is provided in: The guideline development process: an overview for stakeholders, the public and the NHS The guidelines manual. These booklets are available as PDF files from the NICE website (www.nice.org.uk/guidelinesprocess). Information on the progress of the guideline will also be available from the website. Type 2 diabetes (update): final scope (June 2006) Page 8 of 8