Abstract
Aims/hypothesis: 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, NCT01074762), 1,381 patients newly diagnosed with type 2 diabetes were randomized to six years of structured personal care or routine care. The intervention included regular follow up, individualized goal setting supported by continuing medical education of doctors. This observational analysis followed 970 patients, re-examined by the end of intervention, for 13 years 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 hazard ratio for structured personal 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=0.03; 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 genders for diabetes-related death(interaction P=0.015) and all-cause mortality(P=0.005).
Conclusions/Interpretation: Compared to routine care, structured personal diabetes care reduced all-cause mortality, diabetes-related death, any diabetes-related outcome and stroke in women, but not in men. The gender difference was statistically significant for the first two outcomes. In this post hoc analysis of a randomized controlled trial, these observational gendered results cannot be explained by intermediate outcomes like haemoglobinA1c alone, but involves complex social and cultural issues of gender. There is a need to rethink treatment schemes for both genders to benefit from intensified treatment efforts.
Methods: In the Diabetes Care in General Practice(DCGP) multicentre, cluster randomised, controlled trial(ClinicalTrials.gov, NCT01074762), 1,381 patients newly diagnosed with type 2 diabetes were randomized to six years of structured personal care or routine care. The intervention included regular follow up, individualized goal setting supported by continuing medical education of doctors. This observational analysis followed 970 patients, re-examined by the end of intervention, for 13 years 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 hazard ratio for structured personal 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=0.03; 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 genders for diabetes-related death(interaction P=0.015) and all-cause mortality(P=0.005).
Conclusions/Interpretation: Compared to routine care, structured personal diabetes care reduced all-cause mortality, diabetes-related death, any diabetes-related outcome and stroke in women, but not in men. The gender difference was statistically significant for the first two outcomes. In this post hoc analysis of a randomized controlled trial, these observational gendered results cannot be explained by intermediate outcomes like haemoglobinA1c alone, but involves complex social and cultural issues of gender. There is a need to rethink treatment schemes for both genders to benefit from intensified treatment efforts.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Diabetologia |
| Vol/bind | 59 |
| Udgave nummer | 2 |
| Sider (fra-til) | 275-285 |
| Antal sider | 11 |
| ISSN | 0012-186X |
| DOI | |
| Status | Udgivet - 1 feb. 2016 |
Emneord
- Det Sundhedsvidenskabelige Fakultet
- Gender
- General Practice
- Intervention
- Mortality
- Myocardial Infarction
- Primary Care
- Stroke
- Type 2 Diabetes Mellitus
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