Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicentre, Randomised Study to Examine the Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy
Disease management using a multidisciplinary team to achieve and maintain optimal metabolic and cardiovascular risk factors control in Type 2 diabetic patients with nephropathy reduces the incidence of end stage renal disease (ESRD) and improves clinical outcomes compared to usual clinic-based care
Diabetic patients consume over 10% of health care costs in most developed countries. Over
80% of these resources are used to treat diabetic complications and late stage diseases.
Over 30% of patients admitted to the medical wards in Hong Kong's public hospitals have
diabetes, mainly due to cardiovascular and renal complications. Diabetes is now the leading
cause of end stage renal disease (ESRD), accounting for 30-50% of patients on renal
replacement therapy (RRT). In Hong Kong, the number of patients receiving RRT have increased
by 50% in the last 5 years but the number of patients with ESRD due to diabetes have
doubled. Between 10% and 15% of patients attending medical clinics in local public hospitals
either receive insulin or anti-diabetic drugs. In both community and hospital settings,
between 30% and 50% of diabetic patients have albuminuria, which is by far the most powerful
predictor for early mortality, cardiovascular morbidity and renal disease. Local published
data show that 3-10% of diabetic patients died or developed clinical endpoints yearly.
There are now overwhelming evidence supporting the beneficial effects of optimal control of
cardiovascular risk factors on clinical outcomes in diabetic patients. However, there are
few studies to examine the most effective way to translate these scientific evidence
collected in closely monitored clinical trial situations into daily clinical practice.
Results from this multi-centre, randomized study will provide important information to
health care policy makers regarding the cost effectiveness of disease management using a
multidisciplinary team to deliver a structured care model in light of the growing diabetes
epidemic and the constraints of finite resources and the need for equity.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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