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IntroductionCOVID -19 pandemic has threatened the optimal achievement on type-2 diabetes mellitus (T2DM) target in primary health care (PHC), due to our priority in COVID-19 management, limited access of patients to PHC and their lifestyle changes as the impact of social restrictions. Therefore, the empowerment of capability of patients on diabetes self-care is required through optimal education and support. The use of telehealth in T2DM management has benefits on improving outcomes of patients. We aim to assess the role of telehealth diabetes self-management education (DSME) versus hybrid (telehealth and face-to-face method) diabetes self-management education and support (DSMES) to improve T2DM outcomes in PHC during COVID-19 pandemic. Methods and analysisThis study is an open label randomized-controlled trial that will be conducted in 10 PHCs in Jakarta, Indonesia, involving patients with T2DM. Subjects are classified into 2 groups: DSME group and DSMES group. Intervention will be given every 2 weeks. DSME group will receive 1 educational video every 2 weeks discussing topics about diabetes self-management, while DSMES group will receive 1 educational video and undergo 1 coaching session every 2 weeks. All interventions will be conducted by trained health workers of PHC, who are physicians, nurses, and nutritionists. Our primary outcome is the change of HbA1C level and our secondary outcomes are the changes of nutritional intake, physical activity, quality of life, anthropometric parameter, fasting blood glucose, lipid profile, inflammatory markers, and progression of diabetes complications at 3 and 6 months after intervention compare to the baseline. Ethics and disseminationThis study protocol has been approved by the Health Research Ethics Committee University of Indonesia. Subjects agree to participate will be given written informed consent prior to data collection. Findings from this study will be published in peer-reviewed journals and presented at conferences. Trial Registrationhttp://www.clinicalstrials.gov with identifier number NCT05090488. SummaryO_ST_ABSStrengths and limitations of the studyC_ST_ABSO_LIThis study evaluates the role of hybrid DSMES, which is useful in areas with limited access or on lockdowns. C_LIO_LIThis study will evaluates the implementation of hybrid DSMES, its benefits, difficulties, and obstacles. C_LIO_LIWe uses validated questionnaire instruments and routinely collected clinical data. C_LIO_LIBecause all of our interventions will be conducted by PHCs health workers, our results depend on the ability and adherence of PHCs health workers. C_LI
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Diabetes mellitus (DM) remains one of the most important risk factors for peripheral artery disease (PAD), with approximately 20% of DM patients older than 40 years old are affected with PAD. The current standard management for severe PAD is endovascular intervention with or without surgical bypass. Unfortunately, up to 40% of patients are unable to undergo these revascularization therapies due to excessive surgical risk or adverse vascular side effects.Stem cell therapy has emerged as a novel therapeutic strategy for these ‘no-option’ patients. Several types of stem cells are utilized for PAD therapy, including bone marrow mononuclear cells (BMMNC) and peripheral blood mononuclear cells (PBMNC). Many studies have reported the safety of BMMNC and PBMNC, as well as its efficacy in reducing ischemic pain, ulcer size, pain-free walking distance, ankle-brachial index (ABI), and transcutaneous oxygen pressure (TcPO2). However, the capacity to establish the efficacy of reducing major amputation rates, amputation free survival, and all-cause mortality is limited, as shown by several randomized placebo-controlled trials. The present literature review will focus on comparing safety and efficacy between BMMNC and PBMNC as cell-based management in diabetic patients with PAD who are not suitable for revascularization therapy.
