Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): A cluster-randomised controlled trial

Rebecca K. Simmons, Justin B. Echouffo-Tcheugui, Stephen J. Sharp, Lincoln A. Sargeant, Kate M. Williams, A. Toby Prevost, Ann Louise Kinmonth, Nicholas J. Wareham, Simon J. Griffin

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1741-1748
Number of pages8
JournalThe Lancet
Volume380
Issue number9855
DOIs
StatePublished - Nov 2012
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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    Simmons, R. K., Echouffo-Tcheugui, J. B., Sharp, S. J., Sargeant, L. A., Williams, K. M., Prevost, A. T., Kinmonth, A. L., Wareham, N. J., & Griffin, S. J. (2012). Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): A cluster-randomised controlled trial. The Lancet, 380(9855), 1741-1748. https://doi.org/10.1016/S0140-6736(12)61422-6