A European Evidence-Based Guideline for the Prevention of Type 2 Diabetes

Abstract

Background: The prevalence and socioeconomic burden of type 2 diabetes (T2DM) and associated co-morbidities are rising worldwide. Aims: This guideline provides evidence-based recommendations for preventing T2DM. Methods: A European multidisciplinary consortium systematically reviewed the evidence on the effectiveness of screening and interventions for T2DM prevention using SIGN criteria. Results: Obesity and sedentary lifestyle are the main modifiable risk factors. Age and ethnicity are non-modifiable risk factors. Case-finding should follow a step-wise procedure using risk questionnaires and oral glucose tolerance testing. Persons with impaired glucose tolerance and/or fasting glucose are at high-risk and should be prioritized for intensive intervention. Interventions supporting lifestyle changes delay the onset of T2DM in high-risk adults (number-needed-to-treat: 6.4 over 1.8–4.6 years). These should be supported by inter-sectoral strategies that create health promoting environments. Sustained body weight reduction by ≥ 5 % lowers risk. Currently metformin, acarbose and orlistat can be considered as second-line prevention options. The population approach should use organized measures to raise awareness and change lifestyle with specific approaches for adolescents, minorities and disadvantaged people. Interventions promoting lifestyle changes are more effective if they target both diet and physical activity, mobilize social support, involve the planned use of established behaviour change techniques, and provide frequent contacts. Cost-effectiveness analysis should take a societal perspective. Conclusions: Prevention using lifestyle modifications in high-risk individuals is cost-effective and should be embedded in evaluated models of care. Effective prevention plans are predicated upon sustained government initiatives comprising advocacy, community support, fiscal and legislative changes, private sector engagement and continuous media communication.

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Appendix 1

Oral Glucose Tolerance Test (OGTT)

The oral glucose tolerance test (OGTT) is recommended by the WHO for diagnosis of T2DM.

Preparation and cautions

The OGTT should be performed in the morning, after at least three days of unrestricted carbohydrate intake (more than 150 g of carbohydrate daily). The test should not be done during an acute illness, as the results may not reflect the patient's glucose metabolism when healthy. A full test dose of glucose for adults should not be given to a person weighing less than 43 kg, due to the fact excessive amount of glucose may produce a false positive result.

The OGTT procedure

The test should be implemented after an overnight fast of 10 to 16 hours (water is allowed). Smoking or physical activity is not permitted during the test. Usually the OGTT is scheduled to begin in the morning (7–9 am) as glucose tolerance exhibits a diurnal rhythm with a significant decrease in the afternoon. At baseline, the blood sample for glucose determination is taken. The patient is then given a glucose solution to drink. The standard dose is 75 g of glucose in 250–300 ml of water. It should be ingested within 5 minutes. For children, the test load should be 1.75 g per kg of body weight, up to a maximum of 75 g of glucose, The next blood sample is collected at 120 min after the glucose load.

Plasma glucose measurement in blood samples

The processing of the samples after collection is important to ensure accurate measurement of plasma glucose. This requires rapid separation of the plasma after collection. Laboratory measurements rely upon the use of separated plasma and only immediate separation can prevent the lowering of the glucose in the sample. Only if the plasma separation is completely impossible to be done immediately upon collection, glycolysis inhibitors, e.g. sodium fluoride (6 mg per ml of the whole blood) can be used. Rapid cooling of the sample may also be helpful in reducing the loss of glucose if the plasma cannot be immediately separated. In this case, the sample should be placed immediately after collection into ice-water but the plasma separation should occur within 30 minutes. The plasma should be frozen until the glucose concentration can be measured.

International Federation of Clinical Chemistry (IFCC) recommended that all glucose measuring devices report the results in plasma values. The reason for this recommendation is the fact that plasma glucose values are approximately 11 % higher than the values of whole blood glucose measured in the same sample. Moreover, WHO recommendation is that venous plasma glucose should be the standard method for measuring and reporting. However, it should be noted if one converts from venous to capillary plasma glucose the conversion is different in the case of fasting or post-load glucose values. Fasting values for venous and capillary plasma glucose are identical, while the conversion is necessary only for post-load glucose.

Appendix 2

Methods and Procedures

Methods

The IMAGE project is described in detail on its website (http://www.image-project.eu/). Briefly, the development of this guideline followed a pre-defined step-wise procedure addressing:

(i) Stakeholder involvement: the IMAGE guideline development group included diabetes specialists, public health and primary care health professionals, behavioural and social scientists, epidemiologists, patients' organisations, health professional organisations, multidisciplinary, health economists, and health promotion, health policy and health services researchers (for details see Acknowledgements and website). All stakeholders were consulted at numerous stages including the design of the project, definition of the scope and purpose, identification of relevant evidence and developing and refining drafts and final versions of the guideline.

(ii) Scope and purpose: the overall objectives of the guideline were developed through consultation with all stakeholders by email, teleconference and a 2-day symposium. By this process, the clinical questions and target population covered by the guideline were defined and separate working groups established to synthesise the evidence under the following headings: definitions of risk and target population; screening tools, diagnosis and detection; prevention of T2DM and its comorbidities; supporting change in lifestyle behavior for adults at risk of T2DM; models of care and economic aspects of T2DM prevention; and recommendations for economic evaluation of T2DM prevention strategies.

(iii) Evidence identification and review: systematic methods were used to identify relevant evidence using defined search strategies appropriate to the specific topic (see Methodology sections), use of multiple databases, follow up of cited references, and consultation with experts in the field. Criteria for selecting and evaluating the quality of the evidence were based only on publications in peer-reviewed scientific journals and are described in detail (see Methodology sections). Throughout the guideline, SIGN guidance was used to define the criteria for levels (quality) of evidence and grades of the resulting recommendation, which are provided at the end of each chapter. Health benefits, side effects, and risks were considered in formulating these recommendations which were linked to the supporting evidence. Prior to publication, experts externally reviewed the guideline. A procedure for updating the guideline is to be defined.

(iv) Clarity and presentation: the recommendations were reviewed to ensure they are specific and unambiguous. Contextually specific issues arising in each participating European country were discussed to minimise any misunderstanding or misinterpretation. Different options for management are clearly presented and the key recommendations are easily identifiable. The guideline is supported by tools and materials for its application (see website).

(iv) Implementation and dissemination: Potential organizational barriers to applying the recommendations were discussed and addressed where possible. The potential cost implications of applying the recommendations were considered (recognising that precise values will depend on national circumstances such as mix of inputs and unit costs) and the guideline presents key review criteria for monitoring and/or audit purposes. A plan for disseminating the guideline to relevant professional groups and persons with increased diabetes risk is in development.

(v) Editorial independence: The guideline is editorially independent from the funding body. Conflicts of interest of guideline development members have been recorded in the Acknowledgements.

Procedures

At the initial meeting of the guideline development group (Munich, November 2007), the partners discussed the overall project strategies and, based on their specific expertise, assigned themselves to the different working groups. Working group leaders were decided by consensus within each group. Communication occurred within and across the working groups by email, intranet and face-to-face meetings. During a 2-day meeting (Vienna, March 2008), the available information was pre-screened, exclusion and inclusion criteria defined, methodology for evidence identification, grading and recommendation development was further discussed and additional partners allocated to the working groups. Drafts on specific topics were circulated by email and discussed at a further 1-day meeting (Helsinki, June 2008) and across the WPs at a further 2-day meeting (Mallorca, November 2008). In January 2009, the completed drafts were disseminated as a first version of the completed guideline to all stakeholders via email and intranet. After consensus was reached on the contents, the guideline was shortened and edited. Consensus on the final version of the guideline, authors list and publication strategies was achieved during the final 2-day IMAGE meeting (Lisbon, October 2009).

Strengths and limitations

The evidence-based guideline focuses primarily on the European environment. It does not address specific requirements for ethnic minority groups and people with different social and cultural backgrounds. Although the working groups took note of the specific need for prevention of obesity and diabetes in children with metabolic risk factors, it was determined that this laid outside the scope of this guideline. Although many of the interventions identified can be expected to have similar effects in children, the metabolic, psychosocial, behavioural and medical requirements may be different. Despite these limitations, the IMAGE guideline applies to more than 80 % of people with increased metabolic risk in Europe. Further work is necessary to extend the scope of the guideline and to address the needs of children and specific ethnic groups.