title: The impact of gender on the long-term morbidity and mortality of patients with type 2 diabetes receiving structured personal care: a 13 year follow-up study.
abstract: OBJECTIVE
  The aim of this study was to assess gender differences in mortality and morbidity during 13 follow-up years after 6 years of structured personal care in patients with type 2 diabetes mellitus.
  
  
  METHODS
  In the Diabetes Care in General Practice (DCGP) multicentre, cluster-randomised, controlled trial (ClinicalTrials.gov registration no. NCT01074762), 1,381 patients newly diagnosed with type 2 diabetes were randomised to receive 6 years of either structured personal care or routine care. The intervention included regular follow-up, individualised goal setting and continuing medical education of general practitioners participating in the intervention. Patients were re-examined at the end of intervention. This observational analysis followed 970 patients for 13 years thereafter using national registries. Outcomes were all-cause mortality, incidence of diabetes-related death, any diabetes-related endpoint, myocardial infarction, stroke, peripheral vascular disease and microvascular disease.
  
  
  RESULTS
  In women, but not men, a lower HR for structured personal care vs routine care emerged for any diabetes-related endpoint (0.65, p = 0.004, adjusted; 73.4 vs 107.7 events per 1,000 patient-years), diabetes-related death (0.70, p = 0.031; 34.6 vs 45.7), all-cause mortality (0.74, p = 0.028; 55.5 vs 68.5) and stroke (0.59, p = 0.038; 15.6 vs 28.9). This effect was different between men and women for diabetes-related death (interaction p = 0.015) and all-cause mortality (interaction p = 0.005).
  
  
  CONCLUSIONS
  Compared with routine care, structured personal diabetes care reduced all-cause mortality and diabetes-related death in women but not in men. This gender difference was also observed for any diabetes-related outcome and stroke but was not statistically significant after extensive multivariate adjustment. These observational results from a post hoc analysis of a randomised controlled trial cannot be explained by intermediate outcomes like HbA1c alone, but involves complex social and cultural issues of gender. There is a need to rethink treatment schemes for both men and women to gain benefit from intensified treatment efforts.
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark. marlene.krag@gmail.com.
authors.forename: Marlene Ø
authors.initials: MØ
authors.lastname: Krag
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark.
authors.forename: Lotte
authors.initials: L
authors.lastname: Hasselbalch
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark.
authors.forename: Volkert
authors.initials: V
authors.lastname: Siersma
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark.
authors.forename: Anni B S
authors.initials: AB
authors.lastname: Nielsen
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark.
authors.forename: Susanne
authors.initials: S
authors.lastname: Reventlow
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark.|Research Unit for General Practice, Uni Health Research, Bergen, Norway.|Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
authors.forename: Kirsti
authors.initials: K
authors.lastname: Malterud
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, DK-1014, Copenhagen K, Denmark.
authors.forename: Niels
authors.initials: N
authors.lastname: de Fine Olivarius
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003718:Denmark / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology* / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D057285:Precision Medicine / Q000379:methods; D012648:Self Care / Q000379:methods* / Q000592:standards; D012727:Sex Characteristics; D059039:Standard of Care
keywords: Gender; General practice; Intervention; Mortality; Myocardial infarction; Primary care; Sex; Stroke; Type 2 diabetes mellitus