PMID- 33902656 OWN - NLM STAT- MEDLINE DCOM- 20210617 LR - 20221207 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 22 IP - 1 DP - 2021 Apr 26 TI - Evaluating the effectiveness and utility of a novel culturally-adapted telemonitoring system in improving the glycaemic control of Asians with type-2 diabetes mellitus: a mixed method study protocol. PG - 305 LID - 10.1186/s13063-021-05240-6 [doi] LID - 305 AB - 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. FAU - Goh, Kuan Liang Shawn AU - Goh KLS AUID- ORCID: 0000-0003-4619-9919 AD - SingHealth Polyclinics, Singapore, Singapore. shawn.goh.k.l@singhealth.com.sg. FAU - Lee, Cia Sin AU - Lee CS AD - SingHealth Polyclinics, Singapore, Singapore. AD - SingHealth-Duke NUS Family Medicine Academic Clinical Programme, Singapore, Singapore. FAU - Koh, Choon Huat Gerald AU - Koh CHG AD - MOH Office of Healthcare Transformation, Singapore, Singapore. FAU - Ling, Ng Ling AU - Ling NL AD - MOH Office of Healthcare Transformation, Singapore, Singapore. FAU - Ang, Seng Bin AU - Ang SB AD - MOH Office of Healthcare Transformation, Singapore, Singapore. FAU - Oh, Christina AU - Oh C AD - MOH Office of Healthcare Transformation, Singapore, Singapore. FAU - Lin, Yongqing AU - Lin Y AD - MOH Office of Healthcare Transformation, Singapore, Singapore. FAU - Yuan, Wei AU - Yuan W AD - Singapore Clinical Research Institute, Singapore, Singapore. FAU - Zheng, Qishi Charles AU - Zheng QC AD - Singapore Clinical Research Institute, Singapore, Singapore. FAU - Tan, Ngiap Chuan AU - Tan NC AD - SingHealth Polyclinics, Singapore, Singapore. AD - SingHealth-Duke NUS Family Medicine Academic Clinical Programme, Singapore, Singapore. LA - eng SI - ClinicalTrials.gov/NCT04306770 PT - Clinical Trial Protocol PT - Journal Article DEP - 20210426 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Glycated Hemoglobin A) SB - IM MH - Adult MH - Aged MH - Asian People MH - *Diabetes Mellitus, Type 2/diagnosis/therapy MH - Glycated Hemoglobin/analysis MH - Glycemic Control MH - Humans MH - Middle Aged MH - *Quality of Life MH - Randomized Controlled Trials as Topic MH - Self Care PMC - PMC8072297 OTO - NOTNLM OT - Culturally adapted OT - Diabetes OT - Diabetes mellitus OT - Primary care OT - Randomised controlled trial OT - Tele-management OT - Tele-monitoring OT - Telehealth OT - Telemedicine COIS- The authors declare that they have no competing interests. EDAT- 2021/04/28 06:00 MHDA- 2021/06/22 06:00 PMCR- 2021/04/26 CRDT- 2021/04/27 05:47 PHST- 2020/10/28 00:00 [received] PHST- 2021/03/30 00:00 [accepted] PHST- 2021/04/27 05:47 [entrez] PHST- 2021/04/28 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2021/04/26 00:00 [pmc-release] AID - 10.1186/s13063-021-05240-6 [pii] AID - 5240 [pii] AID - 10.1186/s13063-021-05240-6 [doi] PST - epublish SO - Trials. 2021 Apr 26;22(1):305. doi: 10.1186/s13063-021-05240-6.