Remote Monitoring Systems for Self-Managing Type 2 Diabetes: A Systematic Review Hayat Mushcab* 1, George Kernohan 1,2, PhD, Suzanne Martin 1,2, PhD Abstract Our systematic review aims to evaluate the impact web-based telemonitoring for managing Type 2 Diabetes Mellitus. We used MEDLINE, EMBASE, CINAHL, AMED, Cochrane and PubMed to conduct our search. The technology used, trial design, quality of life and Glycated haemoglobin (HbA1c) outcome measures were extracted from systemic reviews, metaanalyses, randomised controlled trials and cohort studies. From 426 publications identified, 19 met our search criteria; 10 quasi-experiments out of which 7 are pre-post test studies, 2 are cohort studies and 1 is interrupted time-series study, and 9 randomised controlled trials (RCT). Electronic transfer of glucose results from home to hospital appears to be more feasible for healthcare delivery. 15 studies showed positive improvement in HbA1c levels. Finally, it remains challenging to identify evidence in the rapidly changing area of remote monitoring, the optimal design of a telemonitoring system is still uncertain and the impact of the remote glucose transmissions remains controversial. Keywords: Type 2 diabetes; self-management; telemonitoring; telehealth; telemedicine; connected health technology; blood glucose monitoring * Email: hayat.mushcab@gmail.com, Mobile: +447460314350; corresponding author 1 University of Ulster, Jordanstown, Northern Ireland 2 Institute of Nursing and Health Research, Jordanstown, Northern Ireland 1.1 Background According to the International Diabetes Federation, diabetes is one of the leading threats to health globally. Whereas, in 2010, 300 million people worldwide suffered from diabetes and 344 million others were at risk of developing T2DM; which overcomes 90% of all patients with T2DM and it is anticipated by the Federation that if the disease was not managed. The epidemic is predicted to escalate to affect 438 million people by 2030 (Shaw et al. 2010). In the United Kingdom, over 2 million people suffer from T2DM (Diabetes UK 2012) and over 210,000 adults aged 20 years and older on the island of Ireland have diabetes (types 1 and 2 combined) (Balanda et al. 2010). These figures indicate that we are in the midst of an epidemic. Society’s ultimate aim is to prevent T2DM through primary control; however, evidence shows that achieving this goal will be most challenging as the incidence is rapidly rising (Tobe et al. 2009). Selfmanagement of diabetes involves effective patient education as a key element of care. Patient education is an evidence-based component of treatment and care for patients with T2DM (Nes et al. 2012). Such education aims to achieve optimal metabolic control, better compliance with medical treatments, prevention of complications and enhanced quality of life (Carlisle et al. 2012). Recently, telemedicine has been introduced as a powerful tool for healthcare delivery and chronic disease management, including diabetes, and there is an increased demand for telemedicine to support self-management. Healthcare providers and researchers have turned to technology for allowing easier access to healthcare, improving monitoring, better compliance in medication taking, healthy eating and all the other elements needed to achieve diabetes control through self-management (Nes et al. 2012, Fitzner, K. and Moss 2013). This technological approach offers many opportunities; for example it can reduce geographic barriers, where data transmission will provide automated feedback and facilitate patient- healthcare provider communication (Stone et al 2010). Collaboration among all those involved in a diabetes treatment plan – healthcare providers, clinicians, healthcare managers and patients – will enable a more efficient delivery system for diabetes care (Fitzner, K. and Moss 2013, Wojcicki et al 2013). Telemedicine is a broad term that can be defined in various ways (Currell et al 2010). In 1995 Scannell offered the following definition: “Telemedicine is the use of telecommunications for medical diagnosis and patient care. It involves the use of telecommunications technology as a medium for the provision of medical services to sites that are at a distance from the provider. The concept encompasses everything from the use of standard telephone services through high speed, wide band width transmission of digitized signals in conjunction with computers, fibre optics, satellites and other sophisticated peripheral equipment and software” (Scannell et al 1995). A more recent definition from World Health Organization in 2010 (WHO 2010) is: “The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers.” Telemedicine and diabetes have been growing and improving together for decades to bring patients to the desired level of self-management. Telemedicine is a combination of information management and communication technology that promotes, empowers and facilitates patient’s wellbeing (Peate 2013). Telemedicine for diabetes has various forms that can be categorised in three groups: 1) real-time monitoring systems, 2) classical long-term monitoring systems and 3) telemonitoring of diabetes complications (Wojcicki et al 2013). Telemonitoring is defined as the use of information and communication technologies for the transmission of biologic or physiologic data between the patients’ homes and health professionals for data interpretation and decision-making (Meystre 2005) using the Internet for web-based real-time systems. Typically, a hub is installed in patients’ homes or an application installed in their personal computers, smartphones and personal digital assistant devices (PDAs) (Wojcicki et al 2013) so that they can be used regularly, feeding the system data on their condition. This system enables patients to monitor and transmit their biometric data from home, including blood glucose, blood pressure, body weight, dietary habits and activity level, and transfer it remotely to a central data management system, where a healthcare provider on the receiving end of the system systematically monitors a patient’s health status, following their care protocols and providing personalized feedback and recommendations regarding their medication adjustments and lifestyle modification via email or phone (Azar and Gabbay 2009, Sicotte et al 2011). 2.1 Method 2.1.1 Search strategy The following databases were comprehensively searched: the Medical Literature Analysis and Retrieval System Online (Medline), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE), the Allied and Complementary Medicine Database (AMED), Pubmed and the Cochrane Library. A search was also conducted through Google Scholar. Related references used in searched articles were also reviewed. 2.1.2. Search terms Using the Medical Subject Headings (MeSH) thesaurus combined: Type 2 diabetes; selfmanagement; telemonitoring; telehealth; telemedicine; connected health technology; blood glucose monitoring. 2.1.3. Inclusion criteria Primary research studies exploring technological interventions (web-based systems with blood glucose transmission) for T2DM self-management and telecommunication with the healthcare providers were included. Only articles published in English and after 2000 were included. Research designs were categorised as: 1) Quasi-experimental studies, such as interrupted time-series studies, cohort studies and pre-post studies, or 2) Randomised controlled trials (RCTs). The study population in the studies had to be adults (18 years old and above) diagnosed with type 2 diabetes mellitus and prescribed insulin treatment. 2.1.4. Exclusion criteria Publications evaluating telemedicine for other chronic diseases, reviews without primary clinical data, case reports and personal opinion studies were excluded. In addition, studies were excluded which evaluated the use of other forms of telemedicine than web-based telemonitoring: interventions such as video-conferencing, telephone-based consultations and blood glucose results stored in a glucometer for the next clinical appointment. 2.1.5. Data extraction The first author reviewed titles, abstracts and sometimes the methodology of the study to determine if the full text should be included in this review. The articles were reviewed for eligibility by the second and third authors. We included technology for blood glucose data transfer and self-management data. Outcomes were categorised according to which measurement was described and validated, for example HbA1c. Figure A.1: Results of systematic search for internet-based telemedicine interventions involving transmission of blood glucose measures. 3.1. Results The aforementioned search strategies surfaced a total of, 426 publications. As shown in Fig. A.1, only 19 articles met the inclusion/exclusion criteria and were included for analysis. Six were conducted in South Korea (Kim HS, Kim C. and Cho JH), five studies in the USA (Durso S, Stone R, Stamp K, Tang P and Katz R), three in the UK (Turner J, Istepanian R and Larsen M) and two in Taiwan (Guo S and Chen SY). Single studies were conducted in Spain (Rodrigues-Idigoras M), Poland (Bujnowska-Fedak M) and India (Kesavadev). 3.1.1 Quasi-Experimental Studies Ten studies used quasi-experimental designs. The sample size of these studies ranged from 10 to 1000. All participants recruited were adults and the duration of the experiments ranged between six to 70 weeks. The complexity and design of the IT intervention systems used in the studies slightly differed. All studies shared the process of blood glucose data transmission. However, the process and the technology used for data transmission are where the difference is found. 3.1.2 Randomised Controlled Trials Nine studies of the articles included used parallel RCT design. The sample size ranged from 69 to 415 adult participants. These trials evaluated telemedicine systems compared to the standard care provided in each setting. The six studies varied in duration from three to 30 months. 4.1 Discussion Most people with diabetes (85–90%) have the type 2 variant. Optimal care for them relies on the patient’s lifestyle and consistent monitoring from the clinical team. It has been widely expected that telemedicine will enhance self-management of patients with T2DM. To address rapidly increasing demand, healthcare services are moving towards such technological innovations. This review confirms that telemedicine and the timely capturing of patient data related to medical conditions (e.g. clinical, physiological and behavioural) has the potential to significantly enhance type 2 diabetes patients’ clinical and behavioural factors, for the patient as well as the care provider (Jaana and Pare 2007). However, the optimal design for a telemedicine system is still uncertain (Adaji 2008) and the impact of real-time blood glucose transmissions is controversial. The system cannot replace direct interaction with a care provider (Azar and Gabbay 2009). Real-time management and remote monitoring of diabetic patients resulted in significant decrease in HbA1c, as reported in several studies; nevertheless, there were mixed results for biological outcome measures such as HbA1c, BMI and cholesterol levels (Adaji 2008). The studies included in this review showed that participants in both the intervention and the control groups had improved HbA1c after six months; however, the intervention group was consistent throughout the end of the studies and care satisfaction scored higher among the intervention group. In this review we focused our search on trials and studies conducted to evaluate and assess remote telemonitoring solutions for type 2 diabetics. The methodology used to complete this review was efficient with inclusive evidence that strengthens the conclusion that the use of telemonitoring systems is feasible to manage T2DM. However, the scope of remote telemonitoring solutions was limited to real-time interventions. Another limitation to this review is the considerable variability in methods used in the studies included. Quality of the RCTs was assessed using the Jaded Scale elements (Halpern and Douglas 2005). 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