Background: There is a global pandemic of type2 diabetes mellitus (T2DM), mainly in Asia. Thailand has a prevalence of T2DM at 9.6%, which is higher than the world average of 8.9%. Multiple studies have shown that multidisciplinary, team-based, coordinated care has been associated with improved measures of quality care and reduced healthcare utilization. Patients with poor glycemic control and nephropathy are at the highest risk of developing cardiovascular complications and renal failure. Aim: In this study, we aimed to explore the impact of intensive multidisciplinary diabetes mellitus care with patient empowerment versus routine clinical care on the rate of progression of micro and macro vascular complications and peripheral atherosclerotic burden, as measured by change in arterial blood Index (ABI) in patients with persistently elevated HbA1c and nephropathy. Method: The study is randomized controlled trial (RCT) of intensive diabetes mellitus care with patient empowerment versus routine clinical care. Patient in the intensive arm will receive care from a multidisciplinary team consisting of an endocrinologist, diabetes nurse educator, dietitian, renal pharmacist and social worker for counseling. In addition, patients will be provided with tools for self-care empowerment such as glucometers, blood pressure monitors and calendar record to facilitate care, monitoring and education. Patients in the routine clinical care will receive standard clinical care. Follow up (FU) will be 2 years. Primary outcomes include cardiovascular events, rate of progression of nephropathy and development of end-stage renal disease. Secondary endpoints include the proportions of patients with documented improved control of cardiovascular risk factors (HbA1c, blood pressure, low density lipoprotein-(LDL-C), reduction in body weight), frequency of hypoglycemia, hospitalization days and change in ABI. We will also examine the prevalence of peripheral atherosclerosis and the predictive value and usability of lower extremity arterial ultrasound to predict cardio-cerebrovascular events, amputation and peripheral intervention. Results: The cumulative incidence of all events (DM-related complications and all-cause mortality) was 21.2% in the Trial-DM group and 40.6% in the usual care group. Trail-DM led to significantly greater reductions in cardiovascular disease (CVD) risk by 52.6% (95% CI 50.5, 54.6), micro vascular complications by 10.9% (95% CI 6.8, 14.6), mortality by 65.1% (95% CI 61.3, 62.9), specialist attendance by 31.0% (95% CI 30.6, 32.4), emergency attendance by 39.2% (95% CI 36.8, 40.5), and hospitalizations by 53.5% (95% CI 53.2, 56.7). Patients with low baseline CVD risks benefitted the most from Trail-DM, which decreased CVD and mortality risk by 58.4% (95% CI 50.8, 64.5) and 79.6% (95% CI 72.3, 81.0), respectively. Discussion: Diabetes mellitus carries significant health care cost. Patients with poorly glycemic control and nephropathy are at highest risk of developing cardiovascular complications and renal failure. Intensive diabetes mellitus care with patient empowerment may lead to sustained glycemic control, reduction of clinical complications and progression of nephropathy, and incidence of cardiovascular complications.
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