NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE PUBLIC HEALTH GUIDANCE 1 Guidance title SCOPE Prevention of type 2 diabetes: prevention of the progression of pre-diabetes to type 2 diabetes among adults in high-risk groups 1.1 Short title 2 Background a) The National Institute for Health and Clinical Excellence (NICE) has been asked by the Department of Health (DH) to develop guidance on a public health programme aimed at preventing type 2 diabetes mellitus among high-risk groups. The referral has been divided into two separate pieces of complementary guidance. b) This guidance will address the prevention of the progression from pre-diabetes (or impaired blood glucose regulation) to type 2 diabetes among high risk individuals and groups. The other guidance will address the prevention of pre-diabetes among populations and communities at greatest risk, including determinants of health such as environments that support behaviour change. c) NICE public health guidance supports the preventive aspects of relevant national service frameworks (NSFs), where they exist. If it is published after an NSF has been issued, the guidance effectively updates it. Specifically, in this case, the guidance will support NSFs on the following: coronary heart disease and diabetes (DH 2000; 2001; 2002). final scope Page 1 of 17
d) This guidance will support a number of related policy documents including: Equity and excellence: liberating the NHS (DH 2010a) Fair society, healthy lives. Strategic review of health inequalities in England post 2010 (Marmot 2010) Healthy weight, healthy lives: a cross-government strategy for England (DH 2008a) Six years on: delivering the diabetes national service framework (DH 2010b) National stroke strategy (DH 2007) Putting prevention first NHS health check: vascular risk assessment and management best practice guidance (DH 2009) Putting prevention first vascular checks: risk assessment and management (DH 2008b) Securing good health for the whole population (Wanless 2004) e) This guidance will provide recommendations for good practice, based on the best available evidence of effectiveness, including cost effectiveness. It is aimed at professionals, commissioners and managers with public health as part of their remit working within the NHS, local authorities and the wider public, private, voluntary and community sectors. It is particularly aimed at directors of public health, GPs and other doctors, practice nurses, dietitians, public health nutritionists, pharmacists, physiotherapists, podiatrists, optometrists, dentists and others who work in the community, private and voluntary sectors such as those involved in running slimming clubs, health trainers and fitness instructors. It will also be of interest to people diagnosed with pre-diabetes or who are at risk of developing pre-diabetes and their families and carers and other members of the public. final scope Page 2 of 17
f) The guidance will complement NICE guidance on diabetes, behaviour change, obesity, cardiovascular disease, physical activity and maternal and child nutrition. For further details, see section 6. This guidance will be developed using the NICE public health programme process. 3 The need for guidance a) The number of people aged 16 and older with diabetes (diagnosed and undiagnosed) in the UK in 2010 is estimated at approximately 3.1 million. It is estimated that between 2010 and 2030 the prevalence of diabetes in this age group will increase to 4.6 million, or 9.5% of the population. It is predicted that around half of these cases will result from the increasing prevalence of obesity; the other half from the ageing population and changes in ethnic grouping (Yorkshire and Humber Public Health Observatory 2010). b) Diabetes is one of the most prevalent and costly chronic diseases. The complications arising from the disease are associated with damage to the eyes, kidneys and nerves. People with type 2 diabetes have an increased risk of coronary heart disease, peripheral vascular disease and stroke and they are more likely to have hypertension, dyslipidaemia (abnormal blood lipid and lipoprotein levels) and obesity. In England people aged between 20 and 79 years with diabetes are more than twice as likely to die as people without diabetes (Yorkshire and Humber Public Health Observatory 2008). c) People who are overweight or obese are more likely to develop type 2 diabetes, and the risk rises as body weight increases (The DECODE Study Group 2002). d) Diabetes is more prevalent among people of African Caribbean, black African and Asian descent living in the UK than among the final scope Page 3 of 17
white population. In these groups diabetes also tends to develop at a younger age (DH 2006). e) Pre-diabetes occurs when glucose levels are higher than the normal range on a sustained basis, but are not high enough to be diagnosed as diabetes. Like diabetes, pre-diabetes is characterised by insulin resistance and impaired insulin secretion. People with pre-diabetes have impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or they may have both conditions. f) Pre-diabetes is associated with an increased risk of developing type 2 diabetes, but progression to diabetes is not inevitable. More than half of Europeans may have IFG or IGT during their lifetime (The DECODE Study Group 2003). The average risk of developing type 2 diabetes increases from 0.7% per year in those with normal blood glucose levels to between 5% and 10% per year in those with IFG or IGT. Those with both IFG and IGT are twice as likely to develop diabetes as those with either IFG or IGT (Aroda and Ratner 2008). Progression rates from IGT vary with ethnicity, with some black and minority ethnic groups progressing to diabetes at more than twice the rate of white populations (Ramachandran et al. 2006). However, it is possible to move from a pre-diabetic state back to the normal blood glucose range. g) People with pre-diabetes have no symptoms of illness so it can remain unrecognised for years. However, the microvascular changes associated with diabetes may have already developed. In the Diabetes Prevention Programme 8% of those with IGT had signs of diabetic retinopathy (Diabetes Prevention Programme Research Group 2007). There is a linear increase of cardiovascular disease with increasing blood glucose levels both when the blood glucose values are lower than the criteria for diagnosis of type 2 diabetes and in the normal range (The American College of Endocrinology and the American Association of Clinical Endocrinologists 2008). Cardiovascular risk in pre-diabetes may be final scope Page 4 of 17
almost twice that for people without IFG or IGT. Progression from IFG to diabetes results in a further doubling of the risk (The American College of Endocrinology and the American Association of Clinical Endocrinologists 2008). 4 The guidance Public health guidance will be developed according to NICE processes and methods. For details see section 5. This document defines exactly what this guidance will (and will not) examine, and what the guidance developers will consider. The scope is based on a referral from the DH (see appendix A). 4.1 Who is the focus? 4.1.1 Groups that will be covered a) Adults aged 18 years and over with a diagnosis of pre-diabetes using current World Health Organization criteria (World Health Organization 2006), that is either or both: Impaired fasting glucose (IFG) Fasting plasma glucose (FPG) between 6.1 and 6.9 mmol/litre Impaired glucose tolerance (IGT) FPG less than 7.0 mmol/litre and a plasma glucose (2 hours after ingestion of a 75 g oral glucose load, the oral glucose tolerance test) between 7.8 and 11.0 mmol/litre. IFG and IGT can occur as isolated conditions or in combination. The diagnostic criteria for IFG and IGT and type 2 diabetes are expected to be revised by the World Health Organization in 2010. final scope Page 5 of 17
b) The guidance will focus on people who: are of south Asian, African Caribbean, Chinese or black African descent and older than 25 years, or white and aged 40 years or older, and who have one or more of the following characteristics: obesity (a body mass index [BMI] of 30 kg/m 2 or above, or 27.5 kg/m 2 or above if of south Asian or Chinese descent) a waist circumference: greater than 80 cm for women of European or African descent greater than 94 cm for men of European or African descent equal to or greater than 80 cm for women of south Asian or Chinese descent equal to or greater than 90 cm for men of south Asian or Chinese descent (Alberti et al. 2007) a history of cardiovascular disease abnormal blood lipids or lipoprotein level (for example low high-density lipoprotein [HDL] cholesterol) hypertension a first-degree relative with type 2 diabetes sedentary lifestyle. c) If the evidence allows, people with the following characteristics will be covered: severe mental health problems learning disabilities taking medication that can increase the risk of developing diabetes such as steroids, antiretrovirals and some antipsychotics polycystic ovary syndrome low birth weight, that is less than 2.5 kg (5.5 lbs) women with a history of diabetes in pregnancy and women who have had a baby that weighed more than 4.5 kg (9 lbs) at birth. final scope Page 6 of 17
4.1.2 Groups that will not be covered People younger than 18. People with a diagnosis of type 2 diabetes or other forms of diabetes. Pregnant women. 4.2 Activities 4.2.1 Activities/measures that will be covered a) Interventions delivered at individual, family, community and population levels in primary, secondary and tertiary care, the community, residential care sector, and prisons including: Risk assessment, identification and monitoring of adults with IFG/IGT or raised glycated haemoglobin (HbA 1c ). Lifestyle interventions involving any or all of the following: weight-loss strategies (for example, motivational support, slimming clubs) diet (for example, low glycaemic index, reduced fat, controlled carbohydrate, low calorie diets) physical activity (for example, cardiorespiratory training, organised programmes, individual programmes). Pharmacological interventions to reduce hyperglycaemia, according to their licensed indications 1 (for example, metformin, thiazolidinediones) or weight loss medication (for example, orlistat) either alone or with lifestyle interventions. 1 Recommendations will normally fall within licensed indications but exceptionally, and only if clearly supported by evidence, use outside a licensed indication may be recommended. The guidance will assume that prescribers will use a drug s summary of product characteristics to inform decisions made with individual patients. final scope Page 7 of 17
Surgical intervention to aid weight loss (for example, gastric banding) either alone or with pharmacological or lifestyle interventions. b) The guidance will use a public sector perspective, that is, considering NHS and other public sector costs. c) The Programme Development Group will take reasonable steps to identify ineffective measures and approaches. 4.2.2 Activities/measures that will not be covered Treatment and management of type 2 diabetes, gestational diabetes or any other form of diabetes. (Type 1 diabetes, type 2 diabetes and diabetes in pregnancy are the subjects of previously published NICE guidance, see section 6.) 4.3 Key questions and outcomes Below are the overarching questions that will be addressed, along with some of the outcomes that would be considered as evidence of effectiveness: Questions: What are the most effective and cost-effective methods of identifying and monitoring adults with either or both IFG and IGT? What are the most effective and cost-effective methods lifestyle, pharmacological and surgical of preventing or delaying type 2 diabetes in adults with pre-diabetes? How do the effectiveness and cost effectiveness of interventions vary between different communities or groups, including disadvantaged groups? Which interventions or strategies, and which combinations of interventions or strategies, are the most effective and cost effective in preventing or delaying type 2 diabetes in adults with pre-diabetes within a given community? final scope Page 8 of 17
What are the barriers and facilitators that may affect the implementation, effectiveness and cost effectiveness of these interventions or strategies (this should include any barriers and facilitators for specific groups)? Expected outcomes: Prevalence and incidence of type 2 diabetes. Physiological measures: glucose levels (fasting, 2-hour post-glucose load and HbA 1c ), lipid levels (total cholesterol, low density lipoprotein [LDL] and HDL-cholesterol, triglycerides), systolic and diastolic blood pressure aerobic capacity, exercise tolerance tests. Diabetes and cardiovascular and microvascular-related morbidities: vascular disease angina pectoris, myocardial infarction, stroke, peripheral vascular disease and its consequences (such as the need for amputation) microvascular changes and progression to neuropathy, retinopathy, nephropathy autonomic dysfunction erectile dysfunction, pain, sweating. Anthropometric measures: body weight weight loss BMI waist circumference measurement skin fold thickness. Measures of quality of life. Mental wellbeing: depression anxiety. final scope Page 9 of 17
All-cause mortality. Take-up of and adherence to the intervention: frequency, duration and intensity of physical activity dietary constituents, calorie intake. Adverse effects (for example traumatic injuries secondary to leisure physical activity, nutritional deficits, side effects of drugs or surgery). For economic modelling, estimates of length of life and quality of life with and without an intervention will be needed to estimate quality-adjusted life years (QALYs). More information about these terms is available at www.nice.org.uk/website/glossary Intermediate outcomes Knowledge. Beliefs. Self efficacy, locus of control. Comparators used to judge effectiveness and cost effectiveness will include: no intervention similar interventions, for example different types of dietary intervention, different methods of delivering the same intervention different interventions, for example diet versus exercise, lifestyle interventions versus pharmacological or surgical interventions comparing single interventions with packages of interventions. 4.4 Status of this document This is the final scope, incorporating comments from a 4-week consultation, which included a stakeholder meeting on 19 May 2010. final scope Page 10 of 17
5 Further information The public health guidance development process and methods are described in The NICE public health guidance development process: An overview for stakeholders including public health practitioners, policy makers and the public (second edition, 2009) available at www.nice.org.uk/phprocess and Methods for development of NICE public health guidance (second edition, 2009) available at www.nice.org.uk/phmethods 6 Related NICE guidance Published Type 2 diabetes newer agents (partial update of CG66). NICE clinical guideline 87 (2009). Available from www.nice.org.uk/guidance/cg87 Type 2 diabetes. NICE clinical guideline 66 (2008). Available from www.nice.org.uk/guidance/cg66 Diabetes in pregnancy. NICE clinical guideline 63 (2008). Available from www.nice.org.uk/guidance/cg63 Obesity. NICE clinical guideline 43 (2006). Available from www.nice.org.uk/guidance/cg43 Type 1 diabetes. NICE clinical guideline 15 (2004). Available from www.nice.org.uk/guidance/cg15 Diabetes (type 1 and 2) patient education models. NICE technology appraisal guidance 60 (2003). Available from www.nice.org.uk/guidance/ta60 Prevention of cardiovascular disease. NICE public health guidance 25 (2010). Available from www.nice.org.uk/guidance/ph25 Under development Hyperglycaemia in acute coronary syndromes. NICE clinical guideline. Publication date to be confirmed. final scope Page 11 of 17
Type 2 diabetes: preventing pre-diabetes in adults. NICE public health guidance. Publication expected June 2011. Preventing obesity: a whole-system approach. NICE public health guidance Publication expected March 2012. final scope Page 12 of 17
Appendix A Referral from the Department of Health The Department of Health asked NICE to: 'produce public health programme guidance for the health service on the prevention of type 2 diabetes mellitus among high-risk groups'. final scope Page 13 of 17
Appendix B Potential considerations It is anticipated that the Programme Development Group (PDG) will consider the following issues: The ability to identify IFT and IGT has led to the definition of criteria for the state of pre-diabetes. It is not known how people respond to knowing whether their blood glucose levels meet these criteria. Pre-diabetes is an unstable state there is a natural variation in blood glucose levels. Therefore, a person may naturally fluctuate in and out of the state. There is potential for significant improvement in blood glucose levels leading to reversal to blood glucose levels within the normal range. Glucose levels normally fluctuate during the day and are variable from day to day. This means that a single measurement that is at the extremes of a person s normal range can result in inaccurate classification as being, or not being, pre-diabetic. If self-report measures are used there is a risk of selective reporting, for example food portions and quantities may be under-reported and physical activity overestimated. final scope Page 14 of 17
Appendix C References Alberti KGMM, Zimmet P, Shaw J (2007) International Diabetes Federation: A consensus on type 2 diabetes prevention. Diabetic Medicine 24: 451 63 Aroda VR, Ratner R (2008) Approach to the patient with prediabetes. Journal of Clinical Endocrinology and Metabolism 93: 3259 65 Department of Health (2000) National service framework for coronary heart disease. London: Department of Health Department of Health (2001) Modern standards and services models. National service framework for diabetes: standards. London: Department of Health Department of Health (2002) National service framework for diabetes: standards supplementary information: Health inequalities in diabetes. London: Department of Health Department of Health (2006) Health survey England 2004: The health of minority ethnic groups. London: Department of Health Department of Health (2007) National stroke strategy. London: Department of Health Department of Health (2008a) Healthy weight, healthy lives: a crossgovernment strategy for England. London: Department of Health Department of Health (2008b) Putting prevention first vascular checks: risk assessment and management. London: Department of Health Department of Health (2009) Putting prevention first NHS health check: vascular risk assessment and management best practice guidance. London: Department of Health Department of Health (2010a) Equity and excellence: liberating the NHS. London: Department of Health final scope Page 15 of 17
Department of Health (2010b) Six years on: delivering the diabetes national service framework. London: Department of Health Diabetes Prevention Programme Research Group (2007) The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the diabetes prevention programme. Diabetes Medicine 24: 137 44 Marmot M (2010) Fair society, healthy lives. Strategic review of health inequalities in England post 2010 [online]. Available from www.idea.gov.uk/idk/core/page.do?pageid=11057750 Ramachandran A, Snehalatha C, Mary S et al. (2006) The Indian diabetes prevention programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia 49: 289 97 The American College of Endocrinology and the American Association of Clinical Endocrinologists (2008) Diagnosis and management of prediabetes in the continuum of hyperglycemia when do the risks of diabetes begin? A consensus statement. Endocrine Practice 14: 933 46 The DECODE Study Group (2002) Age, body mass index and glucose tolerance in 11 European population-based surveys. Diabetic Medicine 19: 558 65 The DECODE Study Group (2003) Age- and sex-specific prevalence of diabetes and impaired glucose regulation in 13 European cohorts. Diabetes Care 26: 61 9 Wanless D (2004) Securing good health for the whole population. London: HM Treasury World Health Organization (2006) Definition and diagnosis of diabetes mellitus and intermediate hyperglycaemia: report of a WHO/IDF consultation. Available from www.who.int/diabetes/publications/definition%20and%20diagnosis%20of%20 diabetes_new.pdf final scope Page 16 of 17
Yorkshire and Humber Public Health Observatory (2008) Diabetes attributable deaths: estimating the excess deaths among people with diabetes [online]. Available from www.yhpho.org.uk/default.aspx?rid=8467 Yorkshire and Humber Public Health Observatory (2010) APHO diabetes prevalence model for England Available from www.yhpho.org.uk/resource/view.aspx?rid=81090 final scope Page 17 of 17