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AIM: Healthcare professionals are leveraging on telehealth to manage patients with type-2 diabetes mellitus (T2DM). This study aimed to determine the clinical outcomes of patients using a novel tele-monitoring system (OPTIMUM) as compared to the standard of care. METHODS: An open-labelled randomised controlled trial involving 330 Asian patients with T2DM, aged 26-65 years, and suboptimal glycaemic control (HbA1c = 7.5-10%) was conducted in a Singapore public primary care clinic. The patients were assigned in a 1:1 ratio by block randomization to the intervention group to receive: in-app video-based tele-education, tele-monitoring of the blood pressure (BP), capillary glucose and weight via Bluetooth devices and mobile application, followed by algorithm-based tele-management by the OPTIMUM telehealth care team for abnormal parameters. Patients received usual care in the control group. Clinical assessments and self-care-related questionnaires were administered for both groups at baseline and 6 months. RESULTS: Complete data of 159 (intervention) and 160 (control) patients with comparable demographic profiles were analysed. Those in the intervention group showed significantly lower HbA1c by 0.34% (95%CI = -0.57 to -0.11; p = 0.004); first measurement of systolic BP decreased by 2.98â mmHg (95%CI:-5.8 to -0.08; p = 0.044) and diastolic BP by 4.24â mmHg (95%CI = -6.0 to -2.47; p = 0.001); and total cholesterol by 0.18â mmol/L (95%CI: -0.34 to -0.01; p = 0.040) compared to the control group, after adjusting for baseline variables. Questionnaire scores showed significant improvements in medication adherence and self-care behaviour in the intervention group. No significant weight change was noted between groups. CONCLUSION: The OPTIMUM tele-monitoring system improved the glycaemic, BP and total cholesterol control in patients with suboptimal T2DM control by enhancing their medication adherence and self-care over 6 months.
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BACKGROUND: Regular supervision of patients with type-2 diabetes mellitus (T2DM) by healthcare providers is essential to optimise their glycaemic control but is challenging to achieve in current care models. Telemonitoring is postulated to bridge this gap by leveraging on internet-of-things and mobile-health technology. This study aims to determine the effectiveness of a novel telemonitoring system (OPTIMUM) in improving the glycaemic control of patients with T2DM compared with standard of care alone. METHODS: This mixed-method study comprises an initial randomised controlled trial involving 330 Asian adults with T2DM, aged 26-65 years old with an HbA1c of 7.5-10%, with 115 in the intervention and control arms each. Those in the intervention arm will use standardised Bluetooth-enabled devices to transmit their capillary glucose, blood pressure and weight measurements to the OPTIMUM system. Primary care physicians and nurses will remotely supervise them according to an embedded management algorithm for 6 months, including tele-education via weekly videos over 8 weeks and asynchronous tele-consultation if abnormal or absent parameters are detected. Patients in both arms will be assessed at baseline, 6, 12 and 24 months post-recruitment. The primary outcome will be their HbA1c difference between both arms at baseline and 6 months. Blood pressure and weight control; quality of life, medication adherence, confidence in self-management, diabetic literacy and related distress and healthcare utilisation using validated questionnaires; and incident retinal, renal, cardiac and cerebrovascular complications will be compared between the two arms as secondary outcomes at stipulated time-points. Intervention arm patients will be interviewed using qualitative research methods to understand their experience, acceptance and perceived usefulness of the OPTIMUM system. DISCUSSION: Overall, this study seeks to evaluate the effectiveness of cultural-adapted telemonitoring system in improving glycaemic control of Asians with type-2 diabetes mellitus compared to standard of care. The results of this trial will better inform policy makers in adopting telemedicine for population health management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04306770 . Registered on March 13, 2020.