TY - JOUR
T1 - Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge)
T2 - A cluster-randomised controlled trial
AU - Simmons, Rebecca K.
AU - Echouffo-Tcheugui, Justin B.
AU - Sharp, Stephen J.
AU - Sargeant, Lincoln A.
AU - Williams, Kate M.
AU - Prevost, A. Toby
AU - Kinmonth, Ann Louise
AU - Wareham, Nicholas J.
AU - Griffin, Simon J.
N1 - Funding Information:
ADDITION-Cambridge was supported by the Wellcome Trust (grant reference No G061895 ) the Medical Research Council (grant reference no: G0001164 ), National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks), and the National Institute for Health Research. JBE-T was funded by a scholarship from the Gates Cambridge Trust. We received an unrestricted grant from University of Aarhus, Denmark, to support the ADDITION-Cambridge trial. Bio-Rad provided equipment to undertake capillary glucose screening by HbA 1c in general practice. ALK is a National Institute for Health Research (NIHR) Senior Investigator. The Primary Care Research Unit is supported by NIHR Research funds . SJG receives support from the Department of Health NIHR Programme Grant funding scheme ( RP-PG-0606-1259 ). ATP was supported by the NIHR Biomedical Research Centre based at Guy's and St Thomas' NHS Foundation Trust and King's College London. This article presents independent research funded by the NIHR under the Programme Grants for Applied Research programme ( RP-PG-0606-1259 ]. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. We thank the independent trial steering committee (Nigel Stott [Chair], John Weinman, Richard Himsworth, and Paul Little) and all participants, practice nurses, and general practitioners in the ADDITION-Cambridge study. The Primary Care Research Unit at the University of Cambridge and the Medical Research Council Epidemiology Unit in Cambridge jointly coordinated the study. Aside from the authors, the ADDITION-Cambridge study team has included Rebecca Abbott, Amanda Adler, Judith Argles, Gisela Baker, Rebecca Bale, Ros Barling, Daniel Barnes, Mark Betts, Sue Boase, Clare Boothby, Sandra Bovan, Ryan Butler, James Brimbicombe, Parinya Chamnan, Sean Dinneen, Pesheya Doubleday, Sue Emms, Mark Evans, Tom Fanshawe, Francis Finucane, Philippa Gash, Julie Grant, Wendy Hardeman, Robert Henderson, Susie Hennings, Garry King, Georgina Lewis, Christine May Hall, Joanna Mitchell, Richard Parker, Nicola Popplewell, Emanuella De Lucia Rolfe, Megan Smith, Stephen Sutton, Liz White and Fiona Whittle. We also wish to thank the Cambridge University Hospitals NHS Foundation Trust Department of Clinical Biochemistry and the NIHR Cambridge Biomedical Research Centre Core Biochemistry Assay Laboratory for carrying out the biochemical assays and the following groups within the MRC Epidemiology Unit: data management (Adam Dickinson), information technology (Iain Morrison), technical (Matt Sims), and field epidemiology (Paul Roberts, Kim Mwanza, and James Sylvester). The National Primary Care Database is a product of the National Primary Care Research and Development Centre (NPCRDC) at the University of Manchester. It was devised by Deborah Baker. The database was constructed by Justin Hayes at the Regional Research Laboratory, School of Geography, University of Manchester; SEE IT consultancy designed and built the map interface. We thank Andrew Wagner, Mark Hann, and David Reeves (NPCRDC) for cleaning and validating the data sets. Andrew Wagner is the database manager.
PY - 2012/11
Y1 - 2012/11
N2 - Background The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality. Methods In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20 184 individuals aged 40-69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA1c) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to-screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081. Findings Of 16 047 high-risk individuals in screening practices, 15 089 (94%) were invited for screening during 2001-06, 11 737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184 057 person-years of follow up (median duration 9·6 years [IQR 8·9-9·9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1·06, 95% CI 0·90-1·25). We noted no significant reduction in cardiovascular (HR 1·02, 95% CI 0·75-1·38), cancer (1·08, 0·90-1·30), or diabetes-related mortality (1·26, 0·75-2·10) associated with invitation to screening. Interpretation In this large UK sample, screening for type 2 diabetes in patients at increased risk was not associated with a reduction in all-cause, cardiovascular, or diabetes-related mortality within 10 years. The benefits of screening might be smaller than expected and restricted to individuals with detectable disease.
AB - Background The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality. Methods In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20 184 individuals aged 40-69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA1c) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to-screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081. Findings Of 16 047 high-risk individuals in screening practices, 15 089 (94%) were invited for screening during 2001-06, 11 737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184 057 person-years of follow up (median duration 9·6 years [IQR 8·9-9·9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1·06, 95% CI 0·90-1·25). We noted no significant reduction in cardiovascular (HR 1·02, 95% CI 0·75-1·38), cancer (1·08, 0·90-1·30), or diabetes-related mortality (1·26, 0·75-2·10) associated with invitation to screening. Interpretation In this large UK sample, screening for type 2 diabetes in patients at increased risk was not associated with a reduction in all-cause, cardiovascular, or diabetes-related mortality within 10 years. The benefits of screening might be smaller than expected and restricted to individuals with detectable disease.
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U2 - 10.1016/S0140-6736(12)61422-6
DO - 10.1016/S0140-6736(12)61422-6
M3 - Article
C2 - 23040422
AN - SCOPUS:84869094223
SN - 0140-6736
VL - 380
SP - 1741
EP - 1748
JO - The Lancet
JF - The Lancet
IS - 9855
ER -