Screening for type 2 diabetes: a short report for the National Screening Committee

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1 Screening for type 2 diabetes: a short report for the Nationa Screening Committee NR Waugh,* D Shyangdan, S Tayor-Phiips, G Suri and B Ha Warwick Evidence, Warwick Medica Schoo, University of Warwick, Coventry, UK *Corresponding author Decared competing interests of authors: none Note: this is a short report that has been produced with ony one-third of the resources that woud be avaiabe for a fu technoogy assessment report and it cannot be as comprehensive as a fu report woud be. Pubished August 2013 DOI: /hta17350 Scientific summary Screening for type 2 diabetes Heath Technoogy Assessment 2013; Vo. 17: No. 35 DOI: /hta17350 NIHR Journas Library

2 SCIENTIFIC SUMMARY: SCREENING FOR TYPE 2 DIABETES Scientific summary Introduction The prevaence of type 2 diabetes meitus (T2DM) has been increasing, owing to increases in overweight and obesity, and decreasing eves of physica activity, as we as the changing demographic structure of the popuation. The York and Humber Pubic Heath Observatory estimates that about 40% of the increase in Engand is due to changes in age and ethnic group structure, and 60% to ifestyes, especiay obesity. The aim of this short report was to provide an update for the Nationa Screening Committee (NSC) on screening for T2DM. As this review was undertaken to update a previous Heath Technoogy Assessment (HTA) review pubished in 2007 [Waugh N, Scotand G, McNamee P, Giett M, Brennan A, Goyder E, et a. Screening for type 2 diabetes: iterature review and economic modeing. Heath Techno Assess 2007;11(17)], and a more recent Scottish Pubic Heath Network review, the searches were restricted to dates from 2009 onwards, to the end of January 2012, with seected ater studies added. The databases searched were MEDLINE, EMBASE, MEDLINE-in-Process & Other Non-Indexed Citations, Science Citation Index and Conference Proceedings Citation Index. The search was not restricted to a particuar study type, but was restricted to Engishanguage artices. Peope can deveop T2DM without symptoms. Some have symptoms without recognising them as being reated to diabetes. Up to 20% of peope with T2DM may be undiagnosed. They may have diabetic compications such as eye disease (diabetic retinopathy) by the time they are diagnosed, or may suffer a heart attack, without any warning. Undiagnosed diabetes can be detected by screening for eevated bood gucose eves. In addition to diabetes, the condition of impaired gucose toerance (IGT), where bood gucose eves are higher than norma but not yet at diabetic eve, is of pubic heath importance. This is because the risk of cardiovascuar disease (CVD) is increased in peope with IGT compared with peope with norma gucose toerance, and because many peope with IGT wi go on to deveop diabetes. IGT causes no symptoms. In terms of absoute numbers of heart attacks, IGT is a greater probem than diabetes, because, athough the risk of heart disease is somewhat higher with diabetes, there are far more peope with IGT than with undiagnosed diabetes. However, IGT may not be a direct cause but ony a marker for metaboic abnormaities. Impaired gucose toerance is sometimes referred to as pre-diabetes, aong with increased fasting gucose (IFG). This term is unsatisfactory because ony about haf of peope with pre-diabetes progress to diabetes. IGT and IFG are sometimes referred to as impaired gucose reguation or non-diabetic hypergycaemia. Depending on which screening strategy was used, and what cut-off eves were used, popuation screening for T2DM woud find more, or far more, peope with IGT than with diabetes. There are arguments for avoiding categorisation, and for using a measure of bood gucose' such as gycated haemogobin (HbA 1c ) in a quantitative way as part of overa assessment of vascuar disease, aong with bood pressure (BP) and ipids. Someone with a HbA 1c eve in the range %, the IGT range, with no other risk factor eevation, may be at ow risk compared with someone with a HbA 1c eve of 5.6% pus hypertension and raised choestero. ii NIHR Journas Library

3 HEALTH TECHNOLOGY ASSESSMENT 2013 VOL. 17 NO. 35 (SCIENTIFIC SUMMARY) Screening poicies shoud take into account that the prevaence of T2DM rises with age, with about 90% of those affected aged > 50 years, and about 70% aged > 60 years. In seective screening, the first stage coud be identification of peope at high risk by data hed on genera practice computer systems, or by sending out questionnaires to peope at home. If genera practitioner (GP) computer data were used, the QDiabetes Risk Score appears best. If it was decided to mai questionnaires out, the Finnish Diabetes Risk Score (FINDRISC) one coud be used. The main risk factors woud be age, body mass index (BMI) and presence of another metaboic condition, such as hypertension. Ethnicity is aso important, with peope of South Asian ancestry having a higher risk, incuding deveoping T2DM at a ower BMI than white peope. The second stage, in those with high scores, woud be a measure of bood gucose eve. There is no perfect screening test for diabetes, but there is increasing evidence to support the use of HbA 1c testing. A HbA 1c eve of 6.5% indicates diabetes, but needs to be confirmed by a second test, such as a second HbA 1c or a fasting pasma gucose (FPG), or an ora gucose toerance test (OGTT). A HbA 1c eve of 6.0%, but < 6.5%, is associated with a high risk of progression to diabetes, and such peope shoud be foowed up with annua testing. However, even using a HbA 1c eve of 6.0% as the threshod for further testing, about 20% of peope with diabetes woud be missed on an OGTT. Peope of African or South Asian ancestry tend to have higher HbA 1c eves than white peope, so HbA 1c testing in the former is more sensitive. One probem with HbA 1c and FPG tests is that they identify overapping but different groups, with one study showing that haf of those identified by HbA 1c as diabetic or at high risk of diabetes, were not so by FPG, and vice versa. The OGTT is inconvenient and time-consuming, and uptake is poorer than with the HbA 1c test. In screening, using a more acceptabe test with higher uptake but ower sensitivity may ead to more peope being detected than using a ess acceptabe test with higher sensitivity. The use of HbA 1c testing aone remains somewhat controversia. HbA 1c eve is a stronger predictor of CVD than FPG. One option is that the third stage shoud meantime invove both HbA 1c and FPG testing. The added vaue of FPG coud be reviewed in the ight of experience. But even using the combination of HbA 1c and FPG testing woud not detect everyone who woud be diabetic on the OGTT. However, the reproducibiity of the OGTT is far from perfect peope can be diabetic in one week but not the next. Fasting pasma gucose aone woud miss up to one-third of peope with diabetes diagnosed with a fu OGTT, because many peope have non-diabetic fasting eves but diabetic eves after a gucose oad. The roe of the 50-g gucose chaenge test, carried out in non-fasted peope, with pasma gucose (PG) measured at 1 hour after a 50-g gucose oad, needs to be evauated in screening for T2DM but appears promising. Hence, screening coud be done in three stages: first by risk factors; then by testing with HbA 1c ; and then, for those with eves of > 6.0%, repeat HbA 1c and FPG testing or the OGTT. Peope found to have undiagnosed diabetes woud be advised to ose weight and increase physica activity. They might aso be treated for higher than desirabe bood choestero and BP. Some patients might need gucose-owering drug treatment soon after diagnosis. Metformin is the drug of first choice on grounds of safety, efficacy and cost. Queen's Printer and Controer of HMSO This work was produced by Waugh et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. iii

4 SCIENTIFIC SUMMARY: SCREENING FOR TYPE 2 DIABETES Peope found to have IGT woud receive simiar advice, aimed at reduction of cardiovascuar risk, but aso at reducing progression to diabetes. This shoud incude a period of intensive ifestye education on diet and physica activity. Weight oss is the main key to success. The Nationa Institute for Heath and Care Exceence (NICE) has issued pubic heath guidance on interventions for this group. The main probem is that we know what peope shoud do to prevent diabetes but not how to persuade most to do it. Peope with IGT who do not adhere to, or do not succeed on, ifestye intervention, switching to metformin therapy after 1 year is cost-effective in preventing diabetes. Peope with IGT shoud be monitored, probaby annuay, initiay, for progression to diabetes. The ast HTA report on screening for T2DM noted that there had been no trias of screening and intervention. Since then the resuts of two trias have been reported. The first is the ADDITION (Ango-Danish-Dutch Study in Genera Practice of Intensive Treatment and Compication Prevention in Type 2 Diabetic Patients Identified by Screening) tria [Simmons RK, Echouffo- Tcheugui JB, Sharp SJ, Sargeant LA, Wiiams KM, Prevost AT, et a. Screening for type 2 diabetes and popuation mortaity over 10 years (ADDITION-Cambridge): a custer-randomised controed tria. Lancet 2012;380: ]. This was not a tria of screening but was a tria of intensive intervention compared with standard care in peope found to have undiagnosed diabetes by screening. Nevertheess, some essons about screening can be drawn from it because of the variety of screening methods used. Uptake was ower if peope had to have OGTTs, or if screening invoved bood tests on more than one visit. Uptake of bood gucose testing was improved if peope were made aware in advance that they were high risk. Uptake was much ower in South Asian communities. The ADDITION tria showed that peope diagnosed with diabetes through screening were at high risk of CVD, with high prevaence of modifiabe risk factors, such as overweight, high BP and high choestero eves. However, after 5 years of foow-up, there was itte difference in the frequency of cardiovascuar events. The risk of cardiovascuar events was reduced by 17% in the intensive group, hazard ratio (HR) 0.83, but the 95% confidence interva was 0.65 to 1.05, so the difference was not statisticay significant. If it had been, to prevent one CVD event, it woud be necessary to screen 1824 peope to identify 76 peope who woud be treated for 5.3 years. The 10-year data again showed no reduction in cardiovascuar, diabetes-reated or tota mortaity events. The reason for the non-significant difference in the ADDITION study appears to have been that standard care improved, so that improvements in BP and choestero eves in the standard-care arm were simiar to those in the intervention arm. Much of the benefit from diagnosing and treating undiagnosed diabetes comes from treating hypertension and bood ipids, rather than bood gucose. If BP and choestero eves in the genera popuation are now better controed, the benefits of screening for diabetes wi be ess. In summary, the ADDITION study shows that the combination of a risk score and screening for undiagnosed diabetes identified a group with high eves of modifiabe risk factors, and ed to considerabe improvements in BP and bood choestero, with marked rises in the proportions of patients on antihypertensive drugs, statins and aspirin in the standard-care group. So the diagnosis of diabetes triggered a range of interventions. The second is the tria of screening for diabetes from Ey. The 13-year foow-up was pubished in In this randomised controed tria (RCT), one-third of the practice popuation, aged 40 to 65 years, was screened by OGTT in They were invited for repeat screening in and The other two-thirds were initiay not foowed up, but haf (randomy seected) were then invited for screening for diabetes in The GPs were informed of the screening resuts, and coud appy whatever treatment they thought appropriate. iv NIHR Journas Library

5 HEALTH TECHNOLOGY ASSESSMENT 2013 VOL. 17 NO. 35 (SCIENTIFIC SUMMARY) At the 13-year foow-up, there were no differences in cardiovascuar outcomes or sef-reported heath status. Does screening for type 2 diabetes meitus yet meet the Nationa Screening Committee criteria? Criterion 12, on optimisation of existing management of the condition, has not been met. The recent report of the Nationa Audit Office (NAO) gives detais of shortcomings. Criterion 13 requires evidence from high-quaity RCTs that screening is beneficia. This has not been met. The Ey tria of screening showed no benefit. The ADDITION tria was not a tria of screening, but showed no cardiovascuar outcomes benefit from appying intensive management. Criterion 18 on staffing and faciities does not appear to have been met, according to the NAO report, which gives detais on very marked variations in care among primary care trusts. Criterion 19 requires that a other options, incuding prevention, shoud have been considered. In theory, a arge proportion of cases of T2DM coud be prevented if peope avoided becoming overweight or obese. However, there is a difference between what is theoreticay possibe and what can be achieved in reaity. Prevention has so far faied, so the issue is whether or not more efforts shoud be made. It has been considered, so the criterion coud be deemed to have been met. Summary Arguments in favour of screening incude: Type 2 diabetes is becoming more common and many peope with the condition are undiagnosed. Heath promotion measures to prevent T2DM by persuading peope to adopt heathy ifestyes and avoid obesity and overweight have faied. There have been advances in screening methods, incuding refinements in risk scoring, and more convenient bood gucose testing using HbA 1c eves in non-fasting peope. There have been advances in diabetes care, incuding retina screening and a wider range of treatments both for gycaemic contro and reduction of cardiovascuar risk. So it is more advantageous to be diagnosed than a decade or two ago. It has been shown, for exampe, by the ADDITION tria, that peope identified by screening to have T2DM or esser degrees of hypergycaemia have significant, but treatabe, cardiovascuar risk factors. Depending on which test is used and what cut-off is chosen, more peope with esser degrees of hypergycaemia wi be found than peope with diabetes. NICE has recenty issued guidance for this group. Some peope with undiagnosed diabetes wi deveop retinopathy. Arguments against popuation screening: Some of the NSC criteria for a screening programme are not met. In particuar, we now have a tria of screening for diabetes but it found no advantage in heath measures or cardiovascuar morbidity after a 13-year foow-up. Identifying peope at high risk of CVD and appying intensified management, as done in the ADDITION tria, did not resut in any benefit. There is no perfect screening test. The OGTT is inconvenient and time-consuming, requires fasting overnight, and acceptance may be poor. The FPG acks sensitivity. HbA 1c testing costs more than a simpe PG test and wi miss some peope who are identified as diabetic by an OGTT. Queen's Printer and Controer of HMSO This work was produced by Waugh et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. v

6 SCIENTIFIC SUMMARY: SCREENING FOR TYPE 2 DIABETES If other cardiovascuar risk factors are assessed and addressed, the benefits of screening for hypergycaemia are modest in terms of further reducing cardiovascuar risk. The proportion undiagnosed has probaby been reduced by opportunistic screening. Concusions The case for universa screening of those aged > 40 years is not proven. There is a case for seective screening as part of overa vascuar risk assessment. The first stage of seection woud use risk factors. This coud be done using data hed on GP computer systems, using QDiabetes Risk Score, or by sending out questionnaires, using the FINDRISC. (The diabetes fiter used in the NHS Heath Check programme has shortcomings.) Those at high risk woud have a measure of bood gucose. Gycated haemogobin has advantages in not requiring a fasting sampe and it is a predictor of vascuar disease across a wider range than just the diabetic one. However, it acks sensitivity and woud miss some peope with diabetes. The OGTT is more sensitive, but inconvenient, more costy, with imperfect reproducibiity, and ess popuar, meaning that uptake woud be ower. Some important NSC criteria are not met. Decisions on screening for T2DM, with or without IGT, wi be taken in the context of what other screening is being done in each of the four territories of the UK. In Engand, determination of diabetes status might be carried out in the context of the vascuar screening programme, athough it might add itte to the overa vascuar risk score. Absoute vaues of, for exampe, HbA 1c, may be more usefu as part of overa risk than a dichotomous diabetes or not diabetes diagnosis. Funding Funding for this study was provided by the Heath Technoogy Assessment programme of the Nationa Institute for Heath Research. vi NIHR Journas Library

7 Heath Technoogy Assessment HTA/HTA TAR ISSN (Print) ISSN (Onine) Five-year impact factor: Heath Technoogy Assessment is indexed in MEDLINE, CINAHL, EMBASE, The Cochrane Library and the ISI Science Citation Index and is assessed for incusion in the Database of Abstracts of Reviews of Effects. This journa is a member of and subscribes to the principes of the Committee on Pubication Ethics (COPE) ( Editoria contact: The fu HTA archive is freey avaiabe to view onine at Print-on-demand copies can be purchased from the report pages of the NIHR Journas Library website: Criteria for incusion in the Heath Technoogy Assessment journa Reports are pubished in Heath Technoogy Assessment (HTA) if (1) they have resuted from work for the HTA programme, and (2) they are of a sufficienty high scientific quaity as assessed by the reviewers and editors. Reviews in Heath Technoogy Assessment are termed systematic when the account of the search appraisa and synthesis methods (to minimise biases and random errors) woud, in theory, permit the repication of the review by others. HTA programme The HTA programme, part of the Nationa Institute for Heath Research (NIHR), was set up in It produces high-quaity research information on the effectiveness, costs and broader impact of heath technoogies for those who use, manage and provide care in the NHS. Heath technoogies are broady defined as a interventions used to promote heath, prevent and treat disease, and improve rehabiitation and ong-term care. The journa is indexed in NHS Evidence via its abstracts incuded in MEDLINE and its Technoogy Assessment Reports inform Nationa Institute for Heath and Care Exceence (NICE) guidance. HTA research is aso an important source of evidence for Nationa Screening Committee (NSC) poicy decisions. For more information about the HTA programme pease visit the website: This report The research reported in this issue of the journa was funded by the HTA programme as project number 11/18/01. The contractua start date was in August The draft report began editoria review in September 2012 and was accepted for pubication in Apri The authors have been whoy responsibe for a data coection, anaysis and interpretation, and for writing up their work. The HTA editors and pubisher have tried to ensure the accuracy of the authors' report and woud ike to thank the reviewers for their constructive comments on the draft document. However, they do not accept iabiity for damages or osses arising from materia pubished in this report. This report presents independent research funded by the Nationa Institute for Heath Research (NIHR). The views and opinions expressed by authors in this pubication are those of the authors and do not necessariy refect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Heath. If there are verbatim quotations incuded in this pubication the views and opinions expressed by the interviewees are those of the interviewees and do not necessariy refect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Heath. Queen's Printer and Controer of HMSO This work was produced by Waugh et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Pubished by the NIHR Journas Library ( produced by Prepress Projects Ltd, Perth, Scotand (

8 Editor-in-Chief of Heath Technoogy Assessment and NIHR Journas Library Professor Tom Waey Director, NIHR Evauation, Trias and Studies and Director of the HTA Programme, UK NIHR Journas Library Editors Professor Ken Stein Chair of HTA Editoria Board and Professor of Pubic Heath, University of Exeter Medica Schoo, UK Professor Andree Le May Chair of NIHR Journas Library Editoria Group (EME, HS&DR, PGfAR, PHR journas) Dr Martin Ashton-Key Consutant in Pubic Heath Medicine/Consutant Advisor, NETSCC, UK Professor Matthias Beck Chair in Pubic Sector Management and Subject Leader (Management Group), Queen s University Management Schoo, Queen s University Befast, UK Professor Aieen Carke Professor of Heath Sciences, Warwick Medica Schoo, University of Warwick, UK Dr Tessa Criy Director, Crysta Bue Consuting Ltd, UK Dr Peter Davidson Director of NETSCC, HTA, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Dr Tom Marsha Reader in Primary Care, Schoo of Heath and Popuation Sciences, University of Birmingham, UK Professor Wiiam McGuire Professor of Chid Heath, Hu York Medica Schoo, University of York, UK Professor Geoffrey Meads Honorary Professor, Business Schoo, Winchester University and Medica Schoo, University of Warwick, UK Professor Jane Norman Professor of Materna and Feta Heath, University of Edinburgh, UK Professor John Powe Consutant Cinica Adviser, NICE, UK Professor James Raftery Professor of Heath Technoogy Assessment, Wessex Institute, Facuty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Keijnen Systematic Reviews Ltd, UK Professor Heen Roberts Professoria Research Associate, University Coege London, UK Professor Heen Snooks Professor of Heath Services Research, Institute of Life Science, Coege of Medicine, Swansea University, UK Pease visit the website for a ist of members of the NIHR Journas Library Board: Editoria contact:

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