Abstract
BackgroundThere is a global pandemic of type 2 diabetes mellitus (T2DM), especially in Asia. Singapore has a prevalence of T2DM at 10.5%, which is higher than the world average of 8.8%. 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. In this study, we aimed to investigate the impact of intensive multidisciplinary diabetes mellitus care with patient empowerment versus routine clinical care on the rate of progression of micro and macrovascular complications and peripheral atherosclerotic burden, as measured by changes in femoral intima-media thickness (IMT) in patients with persistently elevated HbA1c and nephropathy.MethodsThe study is a single-center randomized controlled trial (RCT) with two study arms - intensive diabetes mellitus care versus routine clinical care. Patients in the intensive arm will receive care from a multidisciplinary team consisting of an endocrinologist, diabetes nurse educator, dietitian, renal pharmacist and medical social worker for counselling. In addition, patients will be provided with tools for self-care empowerment such as glucometers, blood pressure monitors and android tablets to facilitate care, monitoring and education. Patients in the routine clinical care arm will receive standard clinical care. Follow up (FU) will be for 3 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-C (LDL-C), reduction in body weight), frequency of hypoglycemia, hospitalization days and changes in femoral IMT. 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.DiscussionDiabetes mellitus carries significant healthcare costs. Patients with poor 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.Trial registrationClinicalTrials.gov, NCT03413215. Registered on 29 January 2019.
Highlights
The number of individuals with type 2 diabetes mellitus (T2DM) in Singapore, a Southeast Asian city-state with a population of 6.5 million, is estimated to grow from 400, 000 to 670,000 by 2030 and to an alarming 1.0 million by 2050 with the continuing rise in the prevalence of obesity [1]
Patients with poor 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
Summary
Trial design This is a single-center, randomized controlled trial of intensive diabetes mellitus care with patient empowerment versus routine clinical care. At each follow-up visit, the patients will first see the nurse to record blood pressure, body weight and urine and blood tests in the clinic review folder. Secondary endpoints Secondary outcomes include (1) proportion of patients with documented improved control of risk factors and fulfilment of two or more of the “ABC” targets as defined by (a) HbA1c < 7%, (b) blood pressure < 140/90 mmHg and (c) LDL-C < 2.6 mmol/L and/or two of the following changes in risk factor control: (d) at least 0.5% reduction in HbA1c, (e) at least 5 mmHg reduction in systolic BP, (f) at least 0.5 mmol/L reduction in LDLC, (g) at least 3% reduction in body weight, (2) frequency of hypoglycaemia (in the last 3 months) (3) number of hospitalization days and (4) changes in femoral IMT. Access to data The PI and co-investigators will have access to the final trial dataset
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