L J Hansen1, V Siersma, H Beck-Nielsen, N de Fine Olivarius. 1. Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, PO Box 2099, 1014 Copenhagen K, Denmark.
Abstract
AIMS/HYPOTHESIS: This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis. METHODS: A total of 1,381 patients aged ≥ 40 years and newly diagnosed with type 2 diabetes were followed up in national registries for 19 years. Clinical follow-up was at 6 and 14 years after diabetes diagnosis. The original 6 year intervention included regular follow-up and individualised goal setting, supported by prompting of doctors, clinical guidelines, feedback and continuing medical education (ClinicalTrials.gov NCT01074762). The registry-based endpoints were: incidence of any diabetes-related endpoint; diabetes-related death; all-cause mortality; myocardial infarction (MI); stroke; peripheral vascular disease; and microvascular disease. RESULTS: At 14 year clinical follow-up, group differences in risk factors from the 6 year follow-up had levelled out, although the prevalence of (micro)albuminuria and level of triacylglycerols were lower in the intervention group. During 19 years of registry-based monitoring, all-cause mortality was not different between the intervention and comparison groups (58.9 vs 62.3 events per 1,000 patient-years, respectively; for structured personal care, HR 0.94, 95% CI 0.83, 1.08, p = 0.40), but a lower risk emerged for fatal and non-fatal MI (27.3 vs 33.5, HR 0.81, 95% CI 0.68, 0.98, p = 0.030) and any diabetes-related endpoint (69.5 vs 82.1, HR 0.83, 95% CI 0.72, 0.97, p = 0.016). These differences persisted after extensive multivariable adjustment. CONCLUSIONS/ INTERPRETATION: In concert with features such as prompting, feedback, clinical guidelines and continuing medical education, individualisation of goal setting and drug treatment may safely be applied to treat patients newly diagnosed with type 2 diabetes to lower the risk of diabetes complications.
RCT Entities:
AIMS/HYPOTHESIS: This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis. METHODS: A total of 1,381 patients aged ≥ 40 years and newly diagnosed with type 2 diabetes were followed up in national registries for 19 years. Clinical follow-up was at 6 and 14 years after diabetes diagnosis. The original 6 year intervention included regular follow-up and individualised goal setting, supported by prompting of doctors, clinical guidelines, feedback and continuing medical education (ClinicalTrials.gov NCT01074762). The registry-based endpoints were: incidence of any diabetes-related endpoint; diabetes-related death; all-cause mortality; myocardial infarction (MI); stroke; peripheral vascular disease; and microvascular disease. RESULTS: At 14 year clinical follow-up, group differences in risk factors from the 6 year follow-up had levelled out, although the prevalence of (micro)albuminuria and level of triacylglycerols were lower in the intervention group. During 19 years of registry-based monitoring, all-cause mortality was not different between the intervention and comparison groups (58.9 vs 62.3 events per 1,000 patient-years, respectively; for structured personal care, HR 0.94, 95% CI 0.83, 1.08, p = 0.40), but a lower risk emerged for fatal and non-fatal MI (27.3 vs 33.5, HR 0.81, 95% CI 0.68, 0.98, p = 0.030) and any diabetes-related endpoint (69.5 vs 82.1, HR 0.83, 95% CI 0.72, 0.97, p = 0.016). These differences persisted after extensive multivariable adjustment. CONCLUSIONS/ INTERPRETATION: In concert with features such as prompting, feedback, clinical guidelines and continuing medical education, individualisation of goal setting and drug treatment may safely be applied to treat patients newly diagnosed with type 2 diabetes to lower the risk of diabetes complications.
Authors: S E Inzucchi; R M Bergenstal; J B Buse; M Diamant; E Ferrannini; M Nauck; A L Peters; A Tsapas; R Wender; D R Matthews Journal: Diabetologia Date: 2012-04-20 Impact factor: 10.122
Authors: Elizabeth A Walker; Mark Molitch; M Kaye Kramer; Steven Kahn; Yong Ma; Sharon Edelstein; Kellie Smith; Mariana Kiefer Johnson; Abbas Kitabchi; Jill Crandall Journal: Diabetes Care Date: 2006-09 Impact factor: 19.112
Authors: Hertzel C Gerstein; Michael E Miller; Saul Genuth; Faramarz Ismail-Beigi; John B Buse; David C Goff; Jeffrey L Probstfield; William C Cushman; Henry N Ginsberg; J Thomas Bigger; Richard H Grimm; Robert P Byington; Yves D Rosenberg; William T Friedewald Journal: N Engl J Med Date: 2011-03-03 Impact factor: 91.245
Authors: Simon J Griffin; Knut Borch-Johnsen; Melanie J Davies; Kamlesh Khunti; Guy E H M Rutten; Annelli Sandbæk; Stephen J Sharp; Rebecca K Simmons; Maureen van den Donk; Nicholas J Wareham; Torsten Lauritzen Journal: Lancet Date: 2011-06-24 Impact factor: 79.321
Authors: Fangfang Jiao; Eric Yuk Fai Wan; Colman Siu Cheung Fung; Anca Ka Chun Chan; Sarah Morag McGhee; Ruby Lai Ping Kwok; Cindy Lo Kuen Lam Journal: Endocrine Date: 2018-08-28 Impact factor: 3.633
Authors: Hanna Lundström; Volkert Siersma; Anni B Sternhagen Nielsen; John Brodersen; Susanne Reventlow; Per K Andersen; Niels de Fine Olivarius Journal: Diabetologia Date: 2014-03-06 Impact factor: 10.122
Authors: Sofie Jandorf; Volkert Siersma; Rasmus Køster-Rasmussen; Niels de Fine Olivarius; Frans Boch Waldorff Journal: Scand J Prim Health Care Date: 2015-01-16 Impact factor: 2.581
Authors: Fangfang Jiao; Colman Siu Cheung Fung; Yuk Fai Wan; Sarah Morag McGhee; Carlos King Ho Wong; Daisy Dai; Ruby Kwok; Cindy Lo Kuen Lam Journal: Cardiovasc Diabetol Date: 2015-08-14 Impact factor: 9.951
Authors: James Martin; Alan Girling; Krishnarajah Nirantharakumar; Ronan Ryan; Tom Marshall; Karla Hemming Journal: Trials Date: 2016-08-15 Impact factor: 2.279