Impact of Multifactorial Interventions with Medication and Lifestyle Optimization on Patients with Type 2 Diabetes: A Randomised Controlled Trial v1

Le résumé fourni par la source

The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide, with the greatest increase occurring in low- and middle-income countries. The prevalence of diabetes is the highest in the Middle East and North Africa, with approximately 10.9% of the adult population being diagnosed with T2DM. The estimated number of deaths caused by diabetes and its complications reached 368,000 in 2013 in the Middle East and North Africa. In particular, diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease and substantially contributes to cardiovascular events. New approaches of managing patients with diabetes, such as pharmacist-led medication therapy management (MTM), the use of telemedicine technology through mobile applications, dietary and exercise interventions, and intensive serum electrolyte panel monitoring have been shown to be beneficial for monitoring and managing diabetes complications, including DKD progression. However, the impact of each intervention or a combination of such interventions has not been clearly elucidated. Although there is evidence demonstrating the benefit of individual interventions for reducing the burden of chronic T2DM and DKD, the most effective multi-factorial intervention, particularly on UAE population, remains unclear. Such an intervention is likely to involve glycaemic control by promoting adherence to medication and lifestyle, such as diet and exercise and closely monitoring to blood electrolyte levels. These factors have a long-term effect on DKD progression and hard end points, such as cardiovascular events and all-cause mortality. In this study, we will examine the effect of these interventions in a combined multifactorial approach called Pharmacy Intervention Protocol (MPIP), and we will use the Abu Dhabi Health Services Company (SEHA) mobile application, which enables the patient to have access to his medical record, medications, and to book future appointments. The impact and usefulness of the application will be examined in the new pharmacy intervention protocol. Other studies have investigated similar tools in the treatment of patients with complex diseases, who require more frequent visits to achieve tighter glycaemic control or face difficulties in accessing the healthcare system. Moreover, we will include a diet intervention involving pre- and post-diet assessments as well as physical activity assessments from the validated revised Summary of Diabetes Self-Care Activities measure, wherein a healthy diet plan with exercise counseling will be provided by a specialist dietician with the goal of optimising electrolyte levels, which have been demonstrated to be important in diabetes clinical outcomes, chronic kidney disease therapy and prevent progression to DKD. However, more studies are warranted to prove causality. Furthermore, we will use a stepwise approach to correct electrolyte imbalance which includes sodium, potassium and magnesium based on laboratory results, with diet as well as medication therapy modification to treat the patient’s electrolyte abnormalities. This approach has been utilized successfully in another case study to treat a patient who previously required intravenous replacement therapy for 16 years to treat electrolyte abnormalities. Therefore, this randomized control trial will aim to investigate the effect of a multi-factorial intervention approach, involving pharmacist-led medication therapy management (MTM) with medication adherence, diet and exercise counselling, and optimisation of serum electrolyte levels on patients’ clinical outcomes, as well as kidney function in UAE national population with type 2 diabetes mellitus in ambulatory clinic.

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