Telemedicine Chapter 8: Telemedicine and Diabetes Mellitus

This chapter is part of Literature reviews carried out for the Heath Service Executive National Telehealth Steering Group April – July 2020

Systematic Reviews

Avidor, Daniel et al (2020) [Systematic Review]Cost-effectiveness of
Diabetic Retinopathy Screening Programs Using Telemedicine: A Systematic Review1

Diabetic retinopathy (DR)is a significant global public health and economic burden. DR accounts for approximately 15-17% of all cases of total blindness in the USA and Europe. Telemedicine is a new intervention for DR screening, however, there is not enough evidence to support its cost-effectiveness. The aim of this study is to review the most recent published literature on economic evaluations of telemedicine in DR screening and summarize the evidence on the cost-effectiveness of this technology. A systematic search of PubMed, Embase and Google Scholar for relevant articles published between January 2010 and January 2020. Studies were included if they met the following criteria: 1. recruited subjects with either type 1 or type 2 diabetes; 2. evaluated telemedicine technology; 3. patients underwent primary screening for DR; 4. compared a telemedicine-based intervention with standard care; 5. performed an economic evaluation or provided sufficient data for evaluating the cost-effectiveness of the technology used. Results: Of 2,238 articles screened, seven studies were included. Four of the studies were conducted in developed countries: the United States, Singapore and two studies in Canada. Three studies were conducted in developing countries: India, Brazil and South Africa. The patient populations in all studies were diabetic patients over the age of 18, previously not screened for DR. All seven studies used a telemedicine program which included capturing a retinal image and subsequently transmitting it to an ocular imaging center to assess the severity of DR. All studies compared telemedicine to a standard screening method for DR, including the option of no screening as standard of care. Although telemedicine requires initial and maintenance costs, it has the potential to provide significant cost savings by increasing patients’ working ability, increasing independent living ability, increasing quality of life and reducing travel costs.

Conclusions: Diabetic retinopathy telemedicine technology has the potential to provide significant cost savings, especially in low-income populations and rural patients with high transportation costs.

Hazenberg, Cet al (2020) [Systematic Review] Telehealth and Telemedicine Applications for the Diabetic Foot: A Systematic Review2

The aim of this systematic review is to assess the peer-reviewed literature on the psychometric properties, feasibility, effectiveness, costs, and current limitations of using telehealth and telemedicine approaches for prevention and management of diabetic foot disease. MEDLINE/PubMed was searched for peer-reviewed studies on telehealth and telemedicine approaches for assessing, monitoring, preventing, or treating diabetic foot disease. Four modalities were formulated: dermal thermography, hyperspectral imaging, digital photographic imaging, and audio/video/online communication. Outcome measures were: validity, reliability, feasibility, effectiveness, and costs. Sixty-one studies were eligible for analysis. Three randomized controlled trials showed that handheld infrared dermal thermography as home-monitoring tool is effective in reducing ulcer recurrence risk, while one small trial showed no effect. Hyperspectral imaging has been tested in clinical settings to assess and monitor foot disease and conflicting results on its diagnostic use show that this method is still in an experimental stage. Digital photography is used to assess and monitor foot ulcers and preulcerative lesions and was found to be a valid, reliable, and feasible method for telehealth purposes. Audio/video/online communication is mainly used for foot ulcer monitoring. Two randomized controlled trials show similar healing efficacy compared with regular outpatient clinic visits, but no benefit in costs. In conclusion, several technologies with good psychometric properties are available that may be of benefit in helping to assess, monitor, prevent, or treat diabetic foot disease, but in most cases, feasibility, effectiveness, and cost savings still need to be demonstrated to become accepted and used modalities in diabetic foot care.

Timpel, Patrick et al (2020) [Systematic Review] Mapping the Evidence on the Effectiveness of Telemedicine Interventions in Diabetes, Dyslipidemia, and Hypertension: An Umbrella Review of Systematic Reviews and Meta-Analyses3

Background: Telemedicine is defined by three characteristics: 1. using information and communication technologies; 2. covering a geographical distance; and 3. involving professionals who deliver care directly to a patient or a group of patients. It is said to improve chronic care management and self-management in patients with chronic diseases. However, currently available guidelines for the care of patients with diabetes, hypertension, or dyslipidemia do not include evidence-based guidance on which components of telemedicine are most effective for which patient populations. Objective: The primary aim of this study was to identify, synthesize, and critically appraise evidence on the effectiveness of telemedicine solutions and their components on clinical outcomes in patients with diabetes, hypertension, or dyslipidemia.

Methods: We conducted an umbrella review of high-level evidence, including systematic reviews and meta-analyses of randomized controlled trials. On the basis of predefined eligibility criteria, extensive automated and manual searches of the databases PubMed, EMBASE, and Cochrane Library were conducted. Two authors independently screened the studies, extracted data, and carried out the quality assessments. Extracted data were presented according to intervention components and patient characteristics using defined thresholds of clinical relevance. Overall certainty of outcomes was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE)tool.

Results: Overall, 3,564 references were identified, of which 46 records were included after applying eligibility criteria. The majority of included studies were published after 2015. Significant and clinically relevant reduction rates for glycated hemoglobin (HbA1c; ≤-0.5%) were found in patients with diabetes. Higher reduction rates were found for recently diagnosed patients and those with higher baseline HbA1c (>8%). Telemedicine was not found to have a significant and clinically meaningful impact on blood pressure. Only reviews or meta-analyses reporting lipid outcomes in patients with diabetes were found. GRADE assessment revealed that the overall quality of the evidence was low to very low.

Conclusions: The results of this umbrella review indicate that telemedicine has the potential to improve clinical outcomes in patients with diabetes. Although subgroup-specific effectiveness rates favoring certain intervention and population characteristics were found, the low GRADE ratings indicate that evidence can be considered as limited. Future updates of clinical care and practice guidelines should carefully assess the methodological quality of studies and the overall certainty of subgroup-specific outcomes before recommending telemedicine interventions for certain patient populations.

Wang, Youfa et al (2020) [Systematic Review] Effectiveness of Mobile Health Interventions on Diabetes and Obesity Treatment and Management: Systematic Review of Systematic Reviews4

Background: Diabetes and obesity have become epidemics and costly chronic diseases. The impact of mobile health (mHealth)interventions on diabetes and obesity management is promising; however, studies showed varied results in the efficacy of mHealth interventions. Objective: This review aimed to evaluate the effectiveness of mHealth interventions for diabetes and obesity treatment and management on the basis of evidence reported in reviews and meta-analyses and to provide recommendations for future interventions and research.

Methods: We systematically searched the PubMed, IEEE Xplore Digital Library, and Cochrane databases for systematic reviews published between January 1, 2005, and October 1, 2019. We analyzed 17 reviews, which assessed 55,604 original intervention studies, that met the inclusion criteria. Of those, 6 reviews were included in our metaanalysis.

Results: The reviews primarily focused on the use of mobile apps and text messaging and the self-monitoring and management function of mHealth programs in patients with diabetes and obesity. All reviews examined changes in biomarkers, and some reviews assessed treatment adherence (n=7) and health behaviors (n=9). Although the effectiveness of mHealth interventions varied widely by study, all reviews concluded that mHealth was a feasible option and had the potential for improving patient health when compared with standard care, especially for glycemic control (-0.3% to -0.5% greater reduction in hemoglobin A1c) and weight reduction (-1.0 kg to -2.4 kg body weight). Overall, the existing 6 meta-analysis studies showed pooled favorable effects of these mHealth interventions (-0.79, 95% CI -1.17 to -0.42; I2=90.5).

Conclusions: mHealth interventions are promising, but there is limited evidence about their effectiveness in glycemic control and weight reduction. Future research to develop evidence-based mHealth strategies should use valid measures and rigorous study designs. To enhance the effectiveness of mHealth interventions, future studies are warranted for the optimal formats and the frequency of contacting patients, better tailoring of messages, and enhancing usability, which places a greater emphasis on maintaining effectiveness over time.

Haider, Rabbia et al (2019) [Systematic Review] Mobile phone text messaging in improving glycaemic control for patients with type 2 diabetes mellitus: A systematic review and meta-analysis5

Background: Mobile health is the use of mobile technology in developing healthcare, with the aim of reminding and motivating patients to adopt a healthy lifestyle. We conducted a systematic review assessing the effectiveness of text-messaging interventions on HbA1c in patients with Type 2 diabetes mellitus (T2DM). Methods: Two authors independently searched MEDLINE, Embase, CINAHL, Cochrane Register of Randomized Control Trials and PsychInfo. The review included randomized control trials with at least 4 weeks follow up, evaluating the effect of text messaging on HbA1c, in patients with T2DM. Trials involving participants with Type 1 diabetes mellitus, pre-diabetes or gestational diabetes, or other forms of telemedicine were excluded. Studies employing bi-directional messaging were excluded. Results: 208 papers were identified as meeting inclusion criteria and their abstracts reviewed. Of these, we examined the full text article of forty-four studies. Eleven randomized controlled trials were included in the final review, with a total of 1710 participants. One study focused on medication adherence only, while the remaining had educational and motivational messages. Five studies showed a significant improvement in HbA1c with the intervention. The remaining studies demonstrated a trend to improvement in HbA1c. Our meta-analysis on 9 of the 11 studies found an overall reduction in HbA1c of 0.38% (-0.53; -0.23, p-value <0.001). Conclusion: Lifestyle-focused text messaging is a low cost initiative aimed at motivating patients with T2DM to adhere to a healthy lifestyle. We demonstrate that lifestyle focused text messaging is effective, with a significant improvement in HbA1c in the meta-analysis.

Hu, Yuli et al(2019) [Systematic Review] Effect of telemedicine intervention on hypoglycaemia in diabetes patients: A systematic review and meta-analysis of randomised controlled trials6

Introduction: Hypoglycaemia is a clinical syndrome from various causes, which happens when the blood glucose concentration is too low. Many studies show that telemedicine intervention can improve glycemic control and has a positive impact on the management of diabetic patients. The purpose of this study was to evaluate the effect of telemedicine intervention on hypoglycemic event occurrences and results on hemoglobin A1c (HbA1c) and body mass index (BMI). Methods: We searched the Cochrane Library, PubMed, Web of Science, the EBSCO host, and OVID to identify relevant studies published from January 2006 to December 2017. The work of searching, selecting and assessing risk of bias was administrated by two independent reviewers. The primary outcomes were hypoglycemic event rate and HbA1c; the secondary outcome was BMI. Results: From 1246 articles, we identified 14 eligible RCTs (n = 1324). Compared to usual care, telemedicine was found to reduce the odds of hypoglycaemia (odds ratio (OR) = 0.42; 95% confidence interval (CI) = 0.29-0.59; I2 = 32%; p < 0.00001). We found that the clinical relevance declined in HbA1c level compared to control group (mean difference = -0.28; 95% CI = -0.45 to -0.12; I2 = 53%; p = 0.0005), but that telemedicine had no effect on BMI (mean difference = -0.27; 95% CI = -0.86-0.31; I2 = 40%; p = 0.35). Discussion: Compared to usual care, the use of telemedicine was found to improve HbA1c and reduce the risk of moderate hypoglycaemia in diabetic patients, but without significant difference in BMI.

Lee, Puikwan Aet al (2018) [Systematic Review] The Impact of Telehealth Remote Patient Monitoring on Glycemic Control in Type 2 Diabetes: A Systematic Review and Meta-Analysis of Systematic Reviews of Randomised Controlled Trials7

Background: There is a growing body of evidence to support the use of telehealth in monitoring HbA1c levels in people living with type 2 diabetes. However, the overall magnitude of effect is yet unclear due to variable results reported in existing systematic reviews. The objective of this study is to conduct a systematic review and meta-analysis of systematic reviews of randomised controlled trials to create an evidence-base for the effectiveness of telehealth interventions on glycemic control in adults with type 2 diabetes. Methods: Electronic databases including The Cochrane Library, MEDLINE, EMBASE, HMIC, and PsychINFO were searched to identify relevant systematic reviews published between 1990 and April 2016, supplemented by references search from the relevant reviews. Two independent reviewers selected and reviewed the eligible studies. Of the 3279 references retrieved, 4 systematic reviews reporting in total 29 unique studies relevant to our review were included. Both conventional pairwise meta-analyses and network meta-analyses were performed. Results: Evidence from pooling four systematic reviews found that telehealth interventions produced a small but significant improvement in HbA1c levels compared with usual care (MD: -0.55, 95% CI: -0.73 to – 0.36). The greatest effect was seen in telephone-delivered interventions, followed by Internet blood glucose monitoring system interventions and lastly interventions involving automatic transmission of SMBG using a mobile phone or a telehealth unit.

Conclusion: Current evidence suggests that telehealth is effective in controlling HbA1c levels in people living with type 2 diabetes. However,there is need for better quality primary studies as well as systematic reviews of RCTs in order to confidently conclude on the impact of telehealth on glycemic control in type 2 diabetes.

Faruque, Labib Imran et al (2017) [Systematic Review] Effect of Telemedicine on Glycated Hemoglobin in Diabetes: A Systematic Review and Meta-Analysis of Randomized Trials8

Background: Telemedicine, the use of telecommunications to deliver health services, expertise and information, is a promising but unproven tool for improving the quality of diabetes care. We summarized the effectiveness of different methods of telemedicine for the management of diabetes compared with usual care. Methods: We searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials databases (to November 2015) and reference lists of existing systematic reviews for randomized controlled trials (RCTs) comparing telemedicine with usual care for adults with diabetes. Two independent reviewers selected the studies and assessed risk of bias in the studies. The primary outcome was glycated hemoglobin (HbA1C) reported at 3 time points (≤ 3 mo, 4-12 mo and > 12 mo). Other outcomes were quality of life, mortality and episodes of hypoglycemia. Trials were pooled using randomeffects meta-analysis, and heterogeneity was quantified using the I2 statistic. Results: From 3688 citations, we identified 111 eligible RCTs (n = 23 648). Telemedicine achieved significant but modest reductions in HbA1C in all 3 follow-up periods (difference in mean at ≤ 3 mo: – 0.57%, 95% confidence interval [CI] -0.74% to -0.40% [39 trials]; at 4-12 mo: – 0.28%, 95% CI -0.37% to -0.20% [87 trials]; and at > 12 mo: -0.26%, 95% CI – 0.46% to -0.06% [5 trials]). Quantified heterogeneity (I2 statistic) was 75%, 69% and 58%, respectively. In meta-regression analyses, the effect of telemedicine on HbA1C appeared greatest in trials with higher HbA1C concentrations at baseline, in trials where providers used Web portals or text messaging to communicate with patients and in trials where telemedicine facilitated medication adjustment. Telemedicine had no convincing effect on quality of life, mortality or hypoglycemia. Interpretation: Compared with usual care, the addition of telemedicine, especially systems that allowed medication adjustments with or without text messaging or a Web portal, improved HbA1C but not other clinically relevant outcomes among patients with diabetes.

Lee, Shaun Wen Huey et al (2017) [Systematic Review] Comparative effectiveness of telemedicine strategies on type 2 diabetes management: A systematic review and network meta-analysis9

The effects of telemedicine strategies on the management of diabetes is not clear. This study aimed to investigate the impact of different telemedicine strategies on glycaemic control management of type 2 diabetes patients. A search was performed in 6 databases from inception until September 2016 for randomized controlled studies that examined the use of telemedicine in adults with type 2 diabetes. Studies were independently extracted and classified according to the following telemedicine strategies: teleeducation, telemonitoring, telecase-management, telementoring and teleconsultation. Traditional and network meta-analysis were performed to estimate the relative treatment effects. A total of 107 studies involving 20,501 participants were included. Over a median of 6 months follow-up, telemedicine reduced haemoglobin A1c (HbA1c) by a mean of 0.43% (95% CI: -0.64% to -0.21%). Network meta-analysis showed that all telemedicine strategies were effective in reducing HbA1c significantly compared to usual care except for telecase-management and telementoring, with mean difference ranging from 0.37% and 0.71%. Ranking indicated that teleconsultation was the most effective telemedicine strategy, followed by telecase-management plus telemonitoring, and finally teleeducation plus telecase-management. The review indicates that most telemedicine strategies can be useful, either as an adjunct or to replace usual care, leading to clinically meaningful reduction in HbA1c.

Tchero, Huidi et al (2017) [Systematic Review] Telemedicine in Diabetic Foot Care: A Systematic Literature Review of Interventions and Metaanalysis of Controlled Trials10

The care of individuals with diabetic foot ulcers is costly and requires multiple hospital visits. Inadequate care leads to serious complications and a high risk of lower extremity amputation. In this review, we aimed at evaluating whether telemedicine can be effective in diabetic foot patient care. We searched Medline through Embase and PubMed and Cochrane Central Register of Controlled Trials (CENTRAL)for relevant studies, published up to April 2017. The studies were summarized and discussed in a narrative method and a meta-analysis of 2 controlled trials was conducted using the fixed-effects model. The main outcomes, assessed in the retrieved studies were the healing rate and satisfaction of patients and health care personnel. Most of the studies showed that implementing telemonitoring programs increased the rate of complete ulcer healing, while the patients were highly satisfied. Two trials providing data on 213 patients on telemedicine and 301 patients on usual care were included for metaanalysis. Subjects in telemedicine, as well as control groups had statistically similar healing time (43 vs 45 days; P = .83), healing time ratio adjusted for age (1 vs 1.4; P = .1), unhealed ulcers or loss to follow-up (3 of 20 vs 7 of 120; P = .13), and amputations (12 of 193 vs 14 of 182; P = .59). Subjects in the telemedicine group experienced a significantly higher mortality rate (8 of 193 vs 1 of 181; P = .0001) due to unexplained factors. No adverse events were attributed to using the telemedicine technology. The odds of complete ulcer healing were statistically similar between the telemedicine group and controls (odds ratio = 0.86; 95% CI = 0.57-1.33; P = .53). Telemedicine care is promising for the management of diabetic foot patients as the results were comparable with usual care. However, further large-scale studies need to be undertaken before it can be implemented widely.

Alharbi, Nouf Sahal et al (2016) [Systematic Review] Impact of Information Technology-Based Interventions for Type 2 Diabetes Mellitus on Glycemic Control: A Systematic Review and Meta-Analysis11

Background: Information technology-based interventions are increasingly being used to manage health care. However, there is conflicting evidence regarding whether these interventions improve outcomes in people with type 2 diabetes. Objective: The objective of this study was to conduct a systematic review and meta-analysis of clinical trials, assessing the impact of information technology on changes in the levels of hemoglobin A1c (HbA1c) and mapping the interventions with chronic care model (CCM) elements. Methods: Electronic databases PubMed and EMBASE were searched to identify relevant studies that were published up until July 2016, a method that was supplemented by identifying articles from the references of the articles already selected using the electronic search tools. The study search and selection were performed by independent reviewers. Of the 1082 articles retrieved, 32 trials (focusing on a total of 40,454 patients) were included. A random-effects model was applied to estimate the pooled results. Results: Information technology-based interventions were associated with a statistically significant reduction in HbA1c levels (mean difference -0.33%, 95% CI -0.40 to -0.26, P<.001). Studies focusing on electronic self-management systems demonstrated the largest reduction in HbA1c (0.50%), followed by those with electronic medical records (0.17%), an electronic decision support system (0.15%), and a diabetes registry (0.05%). In addition, the more CCM-incorporated the information technology-based interventions were, the more improvements there were in HbA1c levels. Conclusions: Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes. No clinically relevant impact was observed on low-density lipoprotein levels and blood pressure, but there was evidence that the cost of care was lower.

Su, Dejun et al (2016) [Meta-Analysis] Does telemedicine improve treatment outcomes for diabetes? A meta-analysis of results from 55 randomized controlled trials12

Aims: To assess the overall effect of telemedicine on diabetes management and to identify features of telemedicine interventions that are associated with better diabetes management outcomes. Methods: Hedges’s g was estimated as the summary measure of mean difference in HbA1c between patients with diabetes who went through telemedicine care and those who went through conventional, non-telemedicine care using a random-effects model. Q statistics were calculated to assess if the effect of telemedicine on diabetes management differs by types of diabetes, age groups of patients, duration of intervention, and primary telemedicine approaches used. Results: The analysis included 55 randomized controlled trials with a total of 9258 patients with diabetes, out of which 4607 were randomized to telemedicine groups and 4651 to conventional, non-telemedicine care groups. The results favored telemedicine over conventional care (Hedges’s g = -0.48, p<0.001)in diabetes management. The beneficial effect of telemedicine were more pronounced among patients with type 2 diabetes (Hedges’s g = -0.63, p<0.001)than among those with type 1 diabetes (Hedges’s g = -0.27, p=0.027) (Q=4.25, p=0.04). Conclusions: Compared to conventional care, telemedicine is more effective in improving treatment outcomes for diabetes patients, especially for those with type 2 diabetes.

Jalil, Sakib et al (2015) [Meta-Analysis] A Meta-Synthesis of Behavioral Outcomes from Telemedicine Clinical Trials for Type 2 Diabetes and the Clinical User-Experience Evaluation (CUE) 13

A worldwide demographic shift is in progress and the aged population proportion is projected to more than double across the next four decades. Our current healthcare models may not be adequate to handle this shift in demography, which may have serious consequences for the ageing population who are more prone to chronic diseases. One proposed remediation is to provide in-home assisted healthcare with technology-intervened approaches. Telemedicine, telehealth, e-health are paradigms found in scientific literature that provide clinical treatment through a technology intervention. In evidence-based medical science, these technology interventions are evaluated through clinical trials, which are targeted to measure improvements in medical conditions and the treatment’s cost effectiveness. However, effectiveness of a technology also depends on the interaction pattern between the technology and its’ users, especially the patients. This paper presents: 1. a meta-synthesis of clinical trials for technology-intervened treatments of type 2 diabetes; and 2. the Clinical User-Experience Evaluation (CUE). CUE is a recommendation for future telemedicine clinical trials that focuses on the patient as the user from Human-Computer Interaction (HCI) perspective and was developed as part of this research. The clinical trials reviewed were interpreted from a technology perspective and the non-medical or non-biological improvements of the users (patients) rather than the medical outcome. Results show that technology-intervened treatments provide positive behavior changes among patients and are potentially highly beneficial for chronic illness management such as type 2 diabetes. The results from the CUE method show how it complements clinical trials to capture patients’ interaction with a technology.

Mushcab, Hayat et al (2015) [Systematic Review] Web-Based Remote Monitoring Systems for Self-Managing Type 2 Diabetes: A Systematic Review14

This systematic review aims to evaluate evidence for viability and impact of web-based telemonitoring for managing type 2 diabetes mellitus. A review protocol included searching Medline, EMBASE, CINAHL, AMED, the Cochrane Library, and PubMed using the following terms: telemonitoring, type 2 diabetes mellitus, self-management, and web-based Internet solutions. The technology used, trial design, quality of life measures, and the glycated hemoglobin (HbA1c)levels were extracted. This review identified 426 publications; of these, 19 met preset inclusion criteria. Ten quasiexperimental research designs were found, of which seven were preposttest studies, two were cohort studies, and one was an interrupted timeseries study; in addition, there were nine randomized controlled trials. webbased remote monitoring from home to hospital is a viable approach for healthcare delivery and enhances patients’ quality of life. Six of these studies were conducted in South Korea, five in the United States, three in the UK, two in Taiwan, and one each in Spain, Poland, and India. The duration of the studies varied from 4 weeks to 18 months, and the participants were all adults. Fifteen studies showed positive improvement in HbA1c levels. One study showed high acceptance of the technology among participants. It remains challenging to identify clear evidence of effectiveness in the rapidly changing area of remote monitoring in diabetes care. Both the technology and its implementations are complex. The optimal design of a telemedicine system is still uncertain, and the value of the real-time blood glucose transmissions is still controversial.

Randomised Controlled Trials

Lee, Jung Yang et al (2020) [Randomised Controlled Trial] Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial15

Background: Connected devices that allow people with diabetes to monitor their blood glucose levels remotely with data visualization have been shown to improve self-care behavior in diabetes management. However, their effectiveness and usability for a low-middle-income, racially diverse population are unknown. Objective: This study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes. Design: This was a pragmatic 52-week clusterrandomized controlled study among 11 primary care government practices in Malaysia. Participants: People with type 2 diabetes aged 18 and above, who had hemoglobin A1c ≥ 7.5% but less than 11.0% within the past 3 months and resided in the state of Selangor. Intervention: The intervention group received home gluco-telemonitors and transmitted glucose data to a care team who could adjust therapy accordingly. The team also facilitated selfmanagement by supporting participants to improve medication adherence, and encourage healthier lifestyle and use of resources to reduce risk factors. Usual care group received routine healthcare service. Main measure: The primary outcome was the change in HbA1c at 24 weeks and 52 weeks. Secondary outcomes included change in fasting plasma glucose, blood pressure, lipid levels, health-related quality of life, and diabetes self-efficacy. Results: A total of 240 participants were recruited in this study. The telemonitoring group reported larger improvements in glycemic control compared with control at the end of study (week 24, -0.05%; 95% CI -0.10 to 0.00%) and at follow-up (week 52, -0.03%; -0.07 to 0.02%, p = 0.226). Similarly, no differences in other secondary outcomes were observed, including the number of adverse events and health-related quality of life.

Conclusion: This study indicates that there is limited benefit of replacing telemedicine with the current practice of self-monitoring of blood glucose. Further innovative methods to improve patient engagement in diabetes care are needed. Trial registration: identifier: NCT02466880.

Benson, Gretchen Aet al (2019) [Randomised Controlled Trial] Impact of ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes)Telemedicine Randomized Controlled Trial on Diabetes Optimal Care Outcomes in Patients with Type 2 Diabetes16

Background: Clinical care for type 2 diabetes has improved but remains suboptimal. Collaborative, team-based models that maximize skills of different disciplines may improve care for individuals with diabetes, but few have been tested using rigorous research designs. Objective: To investigate the efficacy of a registered dietitian nutritionist-led telemedicine program compared with that of a control group in terms of diabetes optimal care goals. Design: A randomized controlled trial in which participants were assigned to a control or intervention group. Participants/setting: One hundred eighteen adults with type 2 diabetes (mean age, 60 years; 45% female) participated in the study between April 2016 and December 2017. Participants were recruited from separate primary care clinics in two rural Minnesota communities. Intervention: For those assigned to the intervention, registered dietitiannutritionists used a treatment protocol to initiate and titrate therapies for blood glucose, hypertension, and lipid levels in addition to providing medical nutrition therapy; telemedicine visits supplemented usual care. Main outcome measures: Primary outcomes included composite and individual diabetes optimal care goals: hemoglobin A1c, blood pressure, not using tobacco, and taking a statin and aspirin (as appropriate). Secondary measures included physical activity, breakfast, fruits and vegetables, whole grains, body mass index, low-density lipoprotein, and medication adherence. Statistical analysis: Mixed-model regression was used to examine outcomes between baseline and 1-year follow-up. Results: A modest but significantly greater improvement in the number of diabetes optimal care measures met at follow-up was found in the intervention group (3.7 vs 3.2 in the control group [P=0.017]). Among individual measures, the intervention group had significantly greater medication use, with 2.5 and 2.2 higher odds (compared with the control group) of taking a statin [95% CI, 1.0 to 6.24]) and aspirin [95% CI, 0.90 to 5.19] as appropriate, respectively.

Conclusions: ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes)findings suggest that registered dietitian nutritionists following medication treatment protocols can effectively improve care for adults with type 2 diabetes and can serve an instrumental role as part of the health care team in providing evidencebased, patient-centered care. Trial registration: NCT02980978

Franc, Sylvia et al (2019) [Randomised Controlled Trial] Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomized controlled trial17

TeleDiab-2 was a 13-month randomized controlled trial evaluating the efficacy and safety of two telemonitoring systems to optimize basal insulin (BI)initiation in subjects with inadequately controlled type 2 diabetes (HbA1c, 7.5%-10%). A total of 191 participants (mean age 58.7 years, mean HbA1c 8.9%) were randomized into three groups: group 1(G1, standard care, n = 63), group 2 (G2, interactive voice response system, n = 64) and group 3 (G3, Diabeo-BI app software, n = 64). The two telemonitoring systems proposed daily adjustments of BI doses, in order to facilitate the achievement of fasting blood glucose (FBG) values targeted at ~100 mg/dL. At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: -1.44% and G3: -1.48% vs. G1: -0.92%; P < 0.002). Moreover, target FBG was reached by twice as many patients in the telemonitoring groups as in the control group, and insulin doses were also titrated to higher levels. No severe hypoglycaemia was observed in the telemonitoring groups and mild hypoglycaemia frequency was similar in all groups. In conclusion, both telemonitoring systems improved glycaemic control to a similar extent, without increasing hypoglycaemic episodes.

Yaron, Marianna et al (2019) [Randomised Controlled Trial] A Randomized Controlled Trial Comparing a Telemedicine Therapeutic Intervention With Routine Care in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pumps18

Aim: To examine the effectiveness and safety over a 12-month period of a telemedicine intervention in adults with type 1 diabetes (T1D)treated with insulin pumps. Methods: 74 T1D patients on insulin pumps for at least 1 year (mean 19.5 [11.5] years) and HbA1c ≥ 6.5% (≥ 48 mmol/mol) were randomized to the telemedicine (n = 37) or the standard care group (n = 37). The intervention group was instructed to download data from insulin pumps and glucometers monthly. They received immediate phone feedback and recommendations for insulin dose adjustment; and face-to-face visits once in 6 months, compared to once every 3 months for the standard care group. Satisfaction with treatment, quality of life and frequency of hypoglycemic events was evaluated. Results: The mean changes in HbA1c adjusted to baseline were -0.08% (0.25 mmol/mol) vs. -0.01% (0.03 mmol/mol), in the intervention and control groups, respectively (p = 0.18) at 12 months, without an increased frequency of hypoglycemia. Patients in the intervention group felt satisfied and interested in continuing with the treatment (p = 0.04). The quality of life scores were similar in both groups. Direct total costs were 24% less in the intervention group, and indirect total costs decreased by 22% compared to the year preceding the study.

Conclusions: Internet-based insulin dose adjustment is as effective and safe as routine care in adults with type 1 diabetes treated by insulin pumps. For suitable patients, some of the time-consuming routine visits may be replaced by user-friendly digital medicine. Clinical trial registration: Clinical Identifier NCT01887431.

Bertuzzi, Federico et al (2018) [Randomised Controlled Trial]
Teleconsultation in type 1 diabetes mellitus (TELEDIABE)19

Aims: The growing incidence of diabetes and the need to contain healthcare costs emphasize the necessity to identify new models of care. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. The objective was to test the feasibility and the efficacy in the improvement of the glycemic control of the teleconsultation for patients with type 1 diabetes mellitus. Methods: A randomized open-label, parallel arm, controlled trial was conducted in two diabetes centers in Italy. Participants affected by type 1 diabetes mellitus have been randomly (1:1) assigned to receive their visits as standard or a web-based care. Patients in the teleconsultation group can arrange their appointments on a Web site and can also have access to web educational courses or to nutritional and psychological counseling. The primary outcome was the assessment of glycemic control by HbA1c measurement after a 12-month follow-up. Results: Overall 74 participants were followed for 1 year. HbA1c changes were not statistically different within (p = 0.56 for standard care group; p = 0.45 for telemedicine group) and between (p = 0.60) groups when considering differences from baseline to the end of the study. Patients randomized to teleconsultation reported reduced severe hypoglycemic episodes (p = 0.03). In addition, they were largely satisfied with the activities, perceived a good improvement in the self-management of the diabetes, and reported to have a time saving and a cost reduction. Conclusions: In conclusion, TELEDIABE proposes a new system for the management of patients with type 1 diabetes mellitus.

Smith-Strom, Hilde et al (2018) [Randomised Controlled Trial] The Effect of Telemedicine Follow-up Care on Diabetes-Related Foot Ulcers: A Cluster-Randomized Controlled Noninferiority Trial20

Objective: To evaluate whether telemedicine (TM)follow-up of patients with diabetes-related foot ulcers (DFUs)in primary health care in collaboration with specialist health care was noninferior to standard outpatient care (SOC) for ulcer healing time. Further, we sought to evaluate whether the proportion of amputations, deaths, number of consultations per month, and patient satisfaction differed between the two groups. Research design and methods: Patients with DFUs were recruited from three clinical sites in western Norway (2012-2016). The cluster-randomized controlled noninferiority trial included 182 adults (94/88 in the TM/SOC groups)in 42 municipalities/districts. The intervention group received TM follow-up care in the community; the control group received SOC. The primary end point was healing time. Secondary end points were amputation, death, number of consultations per month, and patient satisfaction. Results: Using mixed-effects regression analysis, we found that TM was noninferior to SOC regarding healing time (mean difference -0.43 months, 95% CI -1.50, 0.65). When competing risk from death and amputation were taken into account, there was no significant difference in healing time between the groups (subhazard ratio 1.16, 95% CI 0.85, 1.59). The TM group had a significantly lower proportion of amputations (mean difference -8.3%, 95% CI -16.3%, – 0.5%), and there were no significant differences in the proportion of deaths, number of consultations, or patient satisfaction between groups, although the direction of the effect estimates for these clinical outcomes favored the TM group.

Conclusions: The results suggest that use of TM technology can be a relevant alternative and supplement to usual care, at least for patients with more superficial ulcers. Trial registration: NCT01710774.

Sood, Ajay et al (2018) [Randomised Controlled Trial] Telemedicine consultation for patients with diabetes mellitus: a cluster randomised controlled trial21

Introduction: There is a widening discrepancy between the increasing number of patients with diabetes mellitus and the health care resources available to manage these patients. Telemedicine has been used in a number of instances to improve and deliver health care where traditional care delivery methods may encounter difficulty. We conducted a cluster randomised controlled trial of telemedicine consultation to manage patients with diabetes mellitus. Methods: Eleven primary care centres attached to one Veteran Administration tertiary care centre were randomised to provide patients with diabetes consultation referral either by usual consultation in diabetes clinic or telemedicine consultations via videoconference. Results: Altogether, 199 patients were managed by telemedicine consultation and 83 by usual consultation. Patients in both groups showed a small decrease in haemoglobin A1c, with no statistical difference between the groups (telemedicine consultation -1.01% vs usual consultation -0.68%, p = 0.19). Surveys of patients and semi-structured interviews with primary care providers showed better response and satisfaction with telemedicine consultations.

Discussion: This study shows similar clinical outcomes as measured by glycaemic control for patients with diabetes mellitus having a specialist consultation using real-time telemedicine consultation as compared to in-clinic consultation. Telemedicine consultation was also associated with better patient and primary care provider satisfaction.

Di Bartolo, Paolo et al (2017) [Randomised Controlled Trial] Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the iNewTrend randomized clinical trial22

Aims: To compare iBGStar™ + DMApp [experimental meter + telemedicine system](iBGStar) with a traditional glucose meter (Control)in type 1 diabetes adolescents/young adults. Methods: i-NewTrend was a multicenter, openlabel, randomized trial involving subjects aged 14-24 years, on basal-bolus insulin, HbA1c ≥ 8.0%, and poorly compliant with SMBG: ie <30% of the recommended frequency. Primary end points were change in HbA1c and achievement of compliance with SMBG ≥30% of the recommended frequency after 6 months. Quality of life was also evaluated. A post-trial observational phase was conducted, where both groups used the experimental device. Results: Of 182 randomized patients (51.1% male; age 17.7 ± 3.0 years; diabetes duration 8.8 ± 4.7 years; HbA1c levels 10.0% ± 1.4), 92 were allocated to iBGStar and 90 to Control; 6.5% in iBGStar and 8.9% in Control dropped-out. After 6 months, HbA1c changes (±SE) were -0.44% ± 0.13 in iBGStar and -0.32% ± 0.13 in Control (p = 0.51). In the post-trial phase, HbA1c changes from 6 months (±SE) were -0.07% ± 0.14 in iBGStar and – 0.31% ± 0.14 in Control (p = 0.24). Compliance end point was reached by 53.6% in iBGStar and 55.0% in Control (p = 0.86). Mean daily SMBG measurements increased from 1.1 to 2.3 in both groups without worsening quality oflife. Compliant subjects showed a greater reduction in HbA1c levels (-0.60% ± 0.23 in iBGStar; -0.41% ± 0.21 in Control; p = 0.31). Within iBGStar group, telemedicine users (38.0%) reduced HbA1c by -0.58 ± 0.18. Conclusions: iBGStar was not superior to the traditional meter. Irrespective of the strategy, increasing from 1 to 2 SMBG tests/day was associated with HbA1c reduction in both groups, without pharmacologic interventions. Identifying new technologies effective and acceptable to patients is an option to improve adherence to diabetes care. Trial registration: the trial was registered at, registration number NCT02073188.

Hansen, Caroline Raun et al (2017) [Randomised Controlled Trial] Video Consultations as Add-On to Standard Care Among Patients With Type 2 Diabetes Not Responding to Standard Regimens: A Randomized Controlled Trial23

Objective: To examine whether video consultations preceded by measurements of blood glucose, weight and blood pressure as add-on to standard care could contribute to achieving and maintaining good diabetes control among patients with poorly regulated type 2 diabetes (T2D). Design: Randomized controlled trial. Methods: 165 patients with T2D were randomized 1:1 to telemedicine intervention as add-on to clinic-based care or control [clinic-based care]. The intervention consisted of monthly video conferences with a nurse via a tablet computer and lasted for 32 weeks. Regularly self-monitored measurements of blood sugar, blood pressure and weight were uploaded and visible to patient and nurse. Both groups were followed up six months after the end of the intervention period. Primary endpoint: HbA1c after eight months. Results: Video conferences preceded by uploads of measurements as add-on to clinic-based care led to a significant reduction of HbA1c compared to that in standard care (0.69% vs 0.18%, P = 0.022). However, at six-month follow-up, the inter-group difference in HbA1c-reduction was no longer significant. Non-completers had higher HbA1c levels at baseline and a lower degree of education.

Conclusion: Video consultations preceded by uploading relevant measurements can lead to clinically and statistically significant improvements in glycemic control among patients who have not responded to standard regimens. However, continuing effort and attention are essential as the effect does not persist when intervention ends. Furthermore, future studies should focus on differentiation as the most vulnerable patients are at greater risk of nonadherence. Trial registration: NCT01688778.

Nicolucci, Antonio et al (2015) [Randomised Controlled Trial] A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes24

Background: This study evaluated whether a home telehealth (HT) system enabling the patient to monitor body weight, blood glucose values, and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus, compared with usual practice. Materials and Methods: This was a randomized, parallelgroup (1:1), open-label, multicenter study conducted in general practice. Follow-up was for 12 months. Results: Overall, 29 general practitioners enrolled 302 patients, 153 assigned to the HT group and 149 to the control group. Use of the HT system was associated with a statistically significant reduction in glycated hemoglobin (HbA1c)levels compared with the control group (estimated mean difference, 0.33±0.1; P=0.001). No difference emerged as for body weight, blood pressure, and lipid profile. The proportion of patients reaching the target of HbA1c <7.0% was higher in the HT group than in the control group after 6 months (33.0% vs. 18.7%; P=0.009) and 12 months (28.1% vs. 18.5%; P=0.07). As for quality of life evaluated with the 36- item Short Form health survey, significant differences in favor of the HT group were detected as for physical functioning (P=0.01), role limitations due to emotional problems (P=0.02), mental health (P=0.005), and mental component summary (P=0.03) scores. A lower number of specialist visits was reported in the telemedicine group (incidence rate ratio, 0.72; 95% confidence interval, 0.51-1.01; P=0.06).

Conclusions: Use of the HT system was associated with better metabolic control and quality of life; a marginally nonsignificant lower resource utilization was also documented. No impact was documented on blood pressure, lipid profile, and body weight. Trial registration: NCT02194608.


Banks, JL et al (2020) Use of a Remote Temperature Monitoring Mat for the Early Identification of Foot Ulcers25

Diabetic foot ulcers (DFUs) are responsible for considerable morbidity, mortality, and cost. Remote temperature monitoring (RTM)is an evidenced-based and recommended component of standard foot care for at-risk patients. Although previous research has demonstrated the value of RTM for foot ulcer prevention, its benefits related to the early identification of diabetic foot complications may be underappreciated. This article presents a case series supporting the use of RTM for early identification of DFUs. Materials and methods: The cases of 4 veteran patients who presented consecutively with inflammation, which was detected by a telemedicine temperature monitoring mat, are reported. The authors collected subjective history from each patient via telephone outreach and triaged these patients according to standard diabetic foot care recommendations. Each patient required a clinical exam prompted by the mat and the patient’s subjective history. In each case, the patient required callus debridement upon which a pre-ulcerative lesion or partial-thickness wound was discovered. The DFUs in these 4 cases healed quickly and without complication. In 2 of the cases, the outreach prompted by the mat reestablished specialist foot care after a prolonged period without routine exam. In each of these cases, the RTM mat detected inflammation accompanying a preulcerative lesion or a partialthickness wound, allowing for timely intervention and treatment, including debridement and offloading, which may have the potential to improve care and reduce morbidity, mortality, and costs.

Cai, Xiaoling et al (2020) Achieving Effective and Efficient Basal Insulin Optimal Management by Using Mobile Health Application (APP) for Type 2 Diabetes Patients in China26

Aim: To evaluate the effectiveness of the mobile health application (APP) education in basal insulin optimal management program for insulin-naive type 2 diabetes (T2D) patients in China. Methods: The basal insulin optimal management program was launched in 297 hospitals in China, throughout the six main regions of China. A total of 17,208 insulin-naive patients with T2D who started to use basal insulin were screened. The mobile health APP was downloaded in each recruited patient’s mobile phone and the doctor’s mobile phone. Then, according to the instructions and education materials in the APP, these patients began their self-management of insulin dosage titrations and contacted their doctors by APP if they need help. Results: Overall, 12,530 patients with T2D were finally included in the analysis. The average age was 51.97±12.76 years, and 58% of them were males. The average body mass index is 24.46±3.83 kg/m2, and the average HbA1c at baseline was 8.33±2.11% with 24% of the subjects reaching the target of HbA1c<7.0% at baseline. After 3 months of treatment and educations through the APP, HbA1c decreased significantly from baseline (-1.02±1.72%), with 59% of the patients reaching HbA1c<7.0%. After 6 months, the glycemic control of HbA1c also decreased from baseline significantly (-1.01±1.67%). Dosage of insulin daily was 0.23±0.09 IU/kg at baseline, and 0.23±0.23 IU/kg after 6 months of treatment. Regarding the profiles of hypoglycemia treatment, 3145 patients received basal insulin in combination with mono oral anti-diabetic drug (OAD), 1204 patients with dual OADs, 208 patients with triple OADs, and 17 patients with quarter OADs.

Conclusion: Patients could benefit from the basal insulin optimal management program in selfmanagement by using mobile health APP educations. For T2D patients who are going to start insulin treatment, mobile health APP can help them to reach the target of glycemic control with appropriate dosage of insulin.

Crossen, Stephanieet al (2020) Top 10 Tips for Successfully Implementing a Diabetes Telehealth Program27

Diabetes management is well suited to use of telehealth, and recent improvements in both diabetes technology and telehealth policy make this an ideal time for diabetes providers to begin integrating telehealth into their practices. This article provides background information, specific recommendations for effective implementation, and a vision for the future landscape of telehealth within diabetes care to guide interested providers and practices on this topic.

Garg, Satisk Ket al (2020) Managing New-Onset Type 1 Diabetes During the COVID-19 Pandemic: Challenges and Opportunities28

Background: The current COVID-19 pandemic provides an incentive to expand considerably the use of telemedicine for high-risk patients with diabetes, and especially for the management of type 1 diabetes (T1D). Telemedicine and digital medicine also offer critically important approaches to improve access, efficacy, efficiency, and cost-effectiveness of medical care for people with diabetes. Methods: Two case reports are presented where telemedicine was used effectively and safely after day 1 in person patient education. These aspects of the management of new-onset T1D patients [adult and pediatric]included ongoing diabetes education of the patient and family digitally. The patients used continuous glucose monitoring with commercially available analysis software to generate ambulatory glucose profiles and interpretive summary reports. The adult subject used multiple daily insulin injections; the pediatric patient used an insulin pump. The subjects were managed using a combination of e-mail, Internet via Zoom, and telephone calls. Results: These two cases show the feasibility and effectiveness of use of telemedicine in applications in which we had not used it previously: new-onset diabetes education and insulin dosage management.

Conclusions: The present case reports illustrate how telemedicine can be used safely and effectively for new-onset T1D training and education for both pediatric and adult patients and their families. The COVID-19 pandemic has acutely stimulated the expansion of the use of telemedicine and digital medicine. We conclude that telemedicine is an effective approach for the management of patients with new-onset T1D.

Ghosh, Amerta et al (2020) Telemedicine for diabetes care in India during COVID19 pandemic and national lockdown period: Guidelines for physicians29

Background and aims: In view of restrictions on mobility of patients because of COVID-19 pandemic, face-to-face consultations are difficult. We sought to study the feasibility of telemedicine in this scenario. Results: We discuss evidence and general guidelines regarding the role of telemedicine in patients with diabetes along with its utility and limitations. Conclusions: Telemedicine is a useful tool for managing patients of diabetes during this lockdown period. However, there is limited data and further research is required.

Karpova, Elena V et al (2020) Wearable Non-Invasive Monitors of Diabetes and Hypoxia Through Continuous Analysis of Sweat30

We present here wearable devices for continuous monitoring of diabetes and hypoxia based on continuous analysis of sweat. To induce sweating the clinically relevant procedure [pilocarpine electrophoresis] is used. Being a sufficient requirement for diagnostics, positive correlations in variation rates between glucose and lactate concentrations in sweat and the corresponding values in blood are shown. Continuous monitoring of human condition is possible only with the use of flow-through wearable devices providing a delivery of sweat to the biosensor almost immediately after secretion. Evaluating blood glucose through continuous sweat analysis upon glucose tolerance test, we clearly show that diabetics can actually be monitored reliably via non-invasive approach.

Michaud, Tzeyu L et al (2020) Program completion and glycemic control in a remote patient monitoring program for diabetes management: Does gender matter?31

Aims: To examine gender differences in program completion and glycemic outcomes for patients with type 2 diabetes (T2D)in a remote patient monitoring (RPM) program for diabetes management. Methods: Based on data from an RPM program that enrolled post-discharge T2D patients (n = 1645)in 2014-2017, logistic regression models were estimated to assess gender difference in the likelihood of completing the three-month RPM program; whereas ordinary least squares (OLS) regression models were used to examine gender difference in post-RPM hemoglobin A1c (HbA1c), controlling for demographics, baseline health status, including HbA1c, patient activation scores, and physiological data upload frequency for patients who had completed the program. Results: Among enrolled participants, men had lower odds of completing the three-month RPM program than women (adjusted odds ratio, 0.61; 95% confidence interval [CI], 0.39-0.95). However, among those who completed the program, men had lower post-RPM HbA1c than women (-0.18; 95% CI, -0.33, -0.03) after controlling for baseline HbA1c and other covariates.

Conclusions: While female patients with T2D were more likely to complete the RPM program, they showed a higher glycemic level at the end of the program compared to male patients. To close gender disparities in health, interventions through telemedicine tailored towards women’s diabetes outcomes and men’s engagement level are warranted.

Andres, E et al (2019) Update on research projects in the field of telemedicine in diabetes, with a focus on remote monitoring (telemonitoring)2.0 projects32

Background: This is a narrative review of remote monitoring projects within the field of type 1 (T1D) and type 2 diabetes (T2D), with special attention placed on telemedicine 2.0 projects and studies. Results: Since the beginning of the 1990’s, several telemedicine projects and studies focused on T1D and T2D have been developed. Mainly, these projects and studies show that telemonitoring diabetic result in: improved blood glucose control, a significant reduction in HbA1c, improved patient ownership of the disease, greater patient adherence to therapeutic and hygiene-dietary measures, positive impact on comorbidities (hypertension, weight, dyslipidemia), improved quality of life for patients, and at least good patient receptivity and accountability. To date, the magnitude of its effects remain debatable, especially with the variation in patients’ characteristics (eg background ability for self-management, medical condition), samples selection and approach of treatment of control groups. Over the last 5 years, numerous telemedicine projects based on connected objects and new information and communication technologies (ICT) elements defining telemedicine 2.0 have emerged or are still under development. Two examples are the DIABETe and TELESAGE telemonitoring project which perfectly fits within the telemedicine 2.0 framework, being the firsts to include artificial intelligence (AI) with MyPrediTM and DiabeoTM.

Holubova, Anna et al (2019 )Customizing the Types of Technologies Used by Patients With Type 1 Diabetes Mellitus for Diabetes Treatment: Case Series on Patient Experience33

Background: Despite the fact there are many wearable and mobile medical devices that enable patients to better self-manage their diabetes, not many patients are aware of all the options they have. In addition, there are those who are not fully satisfied with the devices they use, and those who often do not use them effectively. Objective: The study aimed to propose possible changes to the combination of devices used by 6 specific patients for diabetes self-management. We assessed the suitability of selected technical devices for diabetes control. Methods: Data of 6 patients (3 men and 3 women) with type 1 diabetes mellitus, who had been using the Diani telemedicine system for at least 3 months, were analyzed. The suitability of selected technical devices for diabetes control was ascertained using the data obtained via the Diani telemedicine system, as well as the patients’ subjective feelings and statements, their everyday life habits, and self-management of diabetes. Informed consent was signed and obtained from each of the patients included. Results: Each of the presented case studies describes how a given patient handled the system and its specific components based on his or her lifestyle, level of education, habits related to diabetes management, personality type, and other factors. At the conclusion of each case study, the best composition of devices for patients with similar personal descriptions was suggested.

Conclusions: We believe this study can provide relevant guidance on how to help particular patients choose the technology that is best suited for their needs, based on the specific patient information we are able to obtain from them. Furthermore, clinicians or educators should be aware of available technologies a given patient can choose from. In addition, there is a substantial need for proper patient education in order for them to effectively use devices for diabetes self-management.

Lee, Jung Yan et al (2019) Using telemedicine to support care for people with type 2 diabetes mellitus: A qualitative analysis of patients’ perspectives34

Objective: Telemedicine has been promoted as an economical and effective way to enhance patient care, but its acceptance among patients in lowincome and middle-income countries is poorly understood. This study is aimed to explore the experiences and perspectives of people with type 2 diabetes mellitus that used telemedicine to manage their condition. Design: In-depth and focus group interviews were conducted with participants who have engaged in telemedicine. Questions included were participants’ perception on the programme being used, satisfaction as well as engagement with the telemedicine programme. All interviews and focus groups were audio-recorded and transcribed verbatim. Data were analysed using a thematic approach. Participants and setting: People with type 2 diabetes (n=48) who participated in a randomised controlled study which examined the use of telemedicine for diabetes management were recruited from 11 primary care clinics located within the Klang Valley. Results: Twelve focus groups and two in-depth interviews were conducted. Four themes emerged from the analysis: 1. generational difference; 2. independence and convenience, 3. sharing of health data and privacy and 4. concerns and challenges. The main obstacles found in patients using the telemedicine systems were related to Internet connectivity and difficulties experienced with system interface. Cost was also another significant concern raised by participants. Participants in this study were primarily positive about the benefits of telemedicine, including its ability to provide real-time data and disease monitoring and the reduction in clinic visits.

Conclusion: Despite the potential benefits of telemedicine in the long-term care of diabetes, there are several perceived barriers that may limitthe effectiveness of this technology. As such, collaboration between educators, healthcare providers, telecommunication service providers and patients are required to stimulate the adoption and the use of telemedicine. Trial registration: NCT02466880.

Dastjerdi, Mansour Siavash et al (2019) A Roundup of the SimplestMobile Phone Uses in Diabetes Management35

With the increasing use of mobile phones, mHealth has grown to be a very promising subject. However, mHealth programs haven’t been widespread in many countries, especially in developing countries. Health-related phone applications, and in particular diabetes-related mobile apps, are gaining more popularity by the day. Yet, there are still some concerns about the safety and effectiveness of these apps. In this short commentary, we will discuss the simple uses of mobile phones and how they can contribute to the communication between patients and health professional providers.

Yaslam, Maram et al (2019) Non-mydriatic Fundus Camera Screening With Diagnosis by Telemedicine for Diabetic Retinopathy Patients With Type 1 and Type 2 Diabetes: A Hospital-Based Cross-Sectional Study36

Background: Diabetic retinopathy (DR)is considered the fifth leading cause of visual impairment worldwide and is associated with a huge social and economic burden. Objective: Describe the practicality of non-mydriatic funduscopic screening photography for the detection of DR among patients with type 1 and type 2 diabetes. Design: Cross-sectional hospital-based study. Setting: Diabetes center, Riyadh. Patients and methods: Between July and December 2017, patients with diabetes and aged ≥18 years were selected by systematic random sampling from the University Diabetes Center. Fundoscopic eye examination was performed using the TRC-NW8 non-mydriatic camera, which performs ocular coherence tomography (OCT) to detect macular edema. Using telemedicine, pictures were graded by a retinal-specialized ophthalmologist using the international clinical DR disease severity scale. Patients were classified according to the type and severity of DR. Main outcome measures: Detection and classification of DR. Sample size: 978 Saudi patients with diabetes. Results: Of 426 (43.5%) patients with DR, 370 had nonproliferative DR and 55 had proliferative DR. Nineteen (1.9%) had macular edema. The most important risk factors for DR were longer diabetes duration and poor glycemic control. Both older age and insulin use contributed to the higher prevalence of DR and macular edema. DR was more common among type 1 patients at 55.4% compared with 49% among type 2 patients. In addition, more females had macular edema (57.1% versus 42.9% among males). Nine patients with macular edema (47.3%) had hypertension while 154 of 426 patients with DR (36.2%) had hypertension. Conclusion: Non-mydriatic funduscopic screening photography was practical and useful for the detection of DR in patients with type 1 and type 2 diabetes.

Kolltveit, Beate-Christin Hope et al (2018) Telemedicine follow‐up facilitates more comprehensive diabetes foot ulcer care: A qualitative study in home‐based and specialist health care37

Aims and objectives: To investigate the application of a telemedicine intervention in diabetes foot ulcer care, and its implications for the healthcare professionals in the clinical field. Background: Contextualfactors are found to be important when applying technology in health care and applying telemedicine in home-based care has been identified as particularly complex. Design and methods: We conducted field observations and individual interviews among healthcare professionals in home-based care and specialist health care in a diabetes foot care telemedicine RCT [ NCT01710774] during 2016. This study was guided by Interpretive Description, an inductive qualitative methodology. Results: Overall, we identified unequal possibilities for applying telemedicine in diabetes foot ulcer care within the hospital and home care contexts. Different circumstances and possibilities in home-based care made the application of telemedicine as intended more difficult. The healthcare professionals in both care contexts perceived the application of telemedicine to facilitate a more comprehensive approach towards the patients, but with different possibilities to enact it.

Conclusions: Application of telemedicine in home-based care was more challenging than in the outpatient clinic setting. Introducing more updated equipment and minor structural adjustments in consultation time and resources could make the use of telemedicine in home-based care more robust. Relevance to clinical practice: Application of telemedicine in diabetes foot ulcer follow-up may enhance the nursing staff’s ability to conduct comprehensive assessment and care of the foot ulcer as well as the patient’s total situation. Access to adequate equipment and time, particularly in home-based care, is necessary to capitalise on this new technology

Naik, Sapna et al (2018) Identification of factors to increase efficacy of telemedicine screening for diabetic retinopathy in endocrinology practices using the Intelligent Retinal Imaging System (IRIS)platform38

Aims: Diabetic retinopathy (DR) and diabetic macular edema (DME) can be evaluated using telemedicine systems, such as the Intelligent Retinal Imaging Systems (IRIS), in patients with Diabetes Mellitus (DM). In an endocrinology-based population utilizing IRIS we determine prevalence rates of DR and DME, and identify associated epidemiologic correlations. Methods: This is a multicenter, retrospective chart review using screening data from IRIS. Centers for Disease Control and Prevention (CDC) data on epidemiologic variables (by county) namely, prevalence of DM, incidence of DM, obesity, and time of physical inactivity, were compared against prevalence rates of DR found at screening. Results: A total of 10,223 eyes of 5,242 patients with DM were imaged. DR and DME were noted in 1781 (33.98%) and 226 imaging studies (4.31%) respectively. The coefficient of determination was greatest for incidence of DM (R2 = 0.92), followed by DM prevalence (R2 = 0.79), obesity, (R2 = 0.67), and physical inactivity (R2 = 0.34). The presence of DR during screening varied significantly by county (p < 0.001).

Conclusions: Screening in counties with a higher incidence of DM led to a higher prevalence of identified DR at time of screening. The current work suggests that telemedicine screening in areas known to have a higher incidence of DM may be worthwhile.

Reid, Mark Wet al (2018) CoYoT1 Clinic: Home Telemedicine Increases Young Adult Engagement in Diabetes Care39

Background: Young adults with type 1 diabetes (T1D) experience poor glycemic control, disengagement in care, and are often lost to the medical system well into their adult years. Diabetes providers need a new approach to working with the population. The goal of this study was to determine whether an innovative shared telemedicine appointment care model (CoYoT1 Clinic [pronounced as “coyote”; Colorado Young Adults with T1D])for young adults with T1D improves care engagement, satisfaction, and adherence to American Diabetes Association (ADA) guidelines regarding appointment frequency. Subjects and methods: CoYoT1 Clinic was designed to meet the diabetes care needs of young adults (18-25 years of age) with T1D through home telemedicine. Visits occurred every 3 months over the 1-year study (three times by home telemedicine and one time in-person). Outcomes were compared to patients receiving treatment as usual (control). Results: Compared with controls, CoYoT1 patients attended significantly more clinic visits (P < 0.0001) and increased their number of clinic visits from the year before the intervention. Seventy-four percent of CoYoT1 patients were seen four times over the 12-month study period, meeting ADA guidelines, but none in the control group met the ADA recommendation. CoYoT1 patients used diabetes technologies more frequently and reported greater satisfaction with care compared with controls.

Conclusions: Delivering diabetes care by home telemedicine increases young adults’ adherence to ADA guidelines and usage of diabetes technologies, and improves retention in care when compared to controls. Home telemedicine may keep young adults engaged in their diabetes care during this challenging transition period.

Kolltveit, Beate-Christin Hope et al (2017) Conditions for success in introducing telemedicine in diabetes foot care: a qualitative inquiry40

Background: The uptake of various telehealth technologies to deliver health care services at a distance is expanding; however more knowledge is needed to help understand vital components for success in using telehealth in different work settings. This study was part of a larger trial designed to investigate the effect of an interactive telemedicine platform. The platform consisted of a web based ulcer record linked to a mobile phone to provide care for people with diabetic foot ulcers in outpatient clinics in specialist hospital care in collaboration with primary health care. The aim of this qualitative study was to identify perceptions of health care professionals in different working settings with respect to facilitators to engagement and participation in the application of telemedicine. Methods: Ten focus groups were conducted with health care professionals and leaders in Western Norway between January 2014 and June 2015 using Interpretive Description, an applied qualitative research strategy. Results: Four key conditions for success in using telemedicine as a new technology in diabetes foot care were identified: technology and training that were user-friendly; having a telemedicine champion in the work setting; the support of committed and responsible leaders; and effective communication channels at the organizational level.

Conclusions: Successful larger scale implementation of telemedicine must involve consideration of complex contextual and organizational factors associated with different work settings. This form of new care technology in diabetes foot care often involves health care professionals working across different settings with different management systems and organizational cultures. Therefore, attention to the distinct needs of each staff group seems an essential condition for effective implementation.

Porta, Massimo et al (2017) Systematic screening of Retinopathy in Diabetes (REaD project): an Italian implementation campaign41

Purpose: To evaluate the use of telemedicine retinal screening in Italy and to identify potential elements of implementation of this system. Methods: Patients with either new-onset diabetes or no ophthalmologic visit over the previous 2 years and attending 33 referral diabetic centers between midApril 2013 and mid December 2015 were screened. Two partially overlapping nonstereoscopic 45° digital color images were captured from each eye using a fully automated nonmydriatic digital fundus camera. Factors limiting the assessment of retinopathy were explored. Results: Out of 24,473 eligible individuals, 22,466 had complete data. Among them, good-quality images enabling appropriate evaluation of at least one eye were obtained from 19,712 patients (both eyes, n = 18,887). Although nonmydriatic retinographs were provided, 39% of patients were evaluated using mydriasis. The rate of low-quality images in each center was inversely associated with the number of patients assessed. This was more evident for screening in mydriasis: adjusted odds ratio (OR)0.79 (95% confidence interval (CI)0.76-0.82) (p<0.001) vs 0.96 (95% CI 0.94-0.97)(p<0.001). Finally, both the number of patients assessed and use of mydriasis were inversely related to the presence of diabetic retinopathy (DR): adjusted OR 0.93 (95% CI 0.92-0.93) (p<0.001) and 0.88 (95% CI 0.82-0.96)(p<0.001), respectively.

Conclusions: This program confirmed a role for teleophthalmology in the systematic screening of DR and provided important suggestions to improve the system deployed. A high level of training is required for operators to optimize imaging. The role of mydriasis should be evaluated further.

Vujosevic, Stela et al (2017) A decade-long telemedicine screening program for diabetic retinopathy in the north-east of Italy42

Aim: To describe a decade long telemedicine screening for diabetic retinopathy (DR)in the metropolitan area of Padova (North-East Italy) and to report about prevalence/incidence of DR and maculopathy, rate of progression to STDR and optimal screening interval in patients with no DR at first examination. Methods: Observational, longitudinal, cohort study; 9347 patients with Type 1 and Type 2 diabetes mellitus (DM) underwent 17,344 fundus exams (three-45° color photos per eye)in two diabetes clinics and were graded in the Reading Centre, by certified personnel. The incidence of STDR, progression of maculopathy and risk factors were evaluated by log Rank test (Kaplan-Meier method). A receiver operating curve was used to determine the optimal screening interval in patients who at the first examination had no DR. Results: The overall prevalence of DR was 27.6%:12.5% mild non proliferative (NPDR), 11.3% moderate NPDR, 2.9% severe NPDR and 0.9% proliferative (PDR). The overall prevalence of maculopathy was 5.7%: 2.8% mild, 2.2% moderate, and 0.7% severe maculopathy. The 10-year incidence of STDR was: 0.6% in no DR, 5.5% in mild NPDR and 21.1% in moderate NPDR at first examination. The 10-year incidence of maculopathy was: 2.1% mild, 1.7% moderate and 0.2% severe. The incidence of STDR in patients with type 1 and type 2 DM and duration>10years was 8.21% and 8.15%; in type 1 DM with duration <10years was 5.5% and in type 2 DM and duration <10years was 1.91%.In patients with no DR at first screening, the best (sensitivity-specificity)follow-up interval is 2.5years.

Conclusions: Screening every 2.5-year in patients without DR at the first examination seems to be adequate. Duration of disease is a relevant risk factor for progression to STDR, however patients with type 1 DM and duration <10years have greater incidence of STDR than patients with type 2 DM and similar disease duration. Epidemiologic data from this decade-long screening program in the North East of Italy may serve for implementing a national screening program.

DeBuc, Delia Cabrera (2016) The Role of Retinal Imaging and Portable Screening Devices in Tele-ophthalmology Applications for Diabetic Retinopathy Management43

In the years since its introduction, retinal imaging has transformed our capability to visualize the posterior pole of the eye. Increasing practical advances in mobile technology, regular monitoring, and population screening for diabetic retinopathy management offer the opportunity for further development of cost-effective applications through remote assessment of the diabetic eye using portable retinal cameras, smartphone-based devices and telemedicine networks. Numerous retinal imaging methods and mobile technologies in tele-ophthalmology applications have been reported for diabetic retinopathy screening and management. They provide several advantages of automation, sensitivity, specificity, portability, and miniaturization for the development of point-of-care diagnostics for eye complications in diabetes. The aim of this paper is to review the role of retinal imaging and mobile technologies in tele-ophthalmology applications for diabetic retinopathy screening and management. At large, although improvements in current technology and telemedicine services are still needed, telemedicine has demonstrated to be a worthy tool to support health caregivers in the effective management and prevention of diabetes and its complications.

Eszes, Dora J et al (2016) Diabetic Retinopathy Screening Using Telemedicine Tools: Pilot Study in Hungary44

Introduction. Diabetic retinopathy (DR)is a sight-threatening complication of diabetes. Telemedicine tools can prevent blindness. We aimed to investigate the patients’ satisfaction when using such tools and the effect of demographic and socioeconomic factors on participation in screening. Methods. Pilot study involving fundus camera screening and self-administered questionnaire on participants’ experience during fundus examination (comfort, reliability, and future interest in participation), as well as demographic and socioeconomic factors was performed on 89 patients with known diabetes in Csongrád County, a south-eastern region of Hungary. Results. Thirty percent of the patients had never participated in any ophthalmological screening, while 25.7% had DR of some grade based upon a standard fundus camera examination and UK-based DR grading protocol (Spectra™ software). Large majority of the patients were satisfied with the screening and found it reliable and acceptable to undertake examination under pupil dilation; 67.3% were willing to undergo nonmydriatic fundus camera examination again. There was a statistically significant relationship between economic activity, education and marital status, and future interest in participation. Discussion. Participants found digital retinal screening to be reliable and satisfactory. Telemedicine can be a strong tool, supporting eye care professionals and allowing for faster and more comfortable DR screening.

Murchison, Ann Pet al (2016) A Multi-Center Diabetes Eye Screening Study in Community Settings: Study Design and Methodology45

Purpose: Diabetes is the leading cause of new cases of blindness among adults aged 20-74 years within the United States. The Innovative Network for Sight Research group (INSIGHT) designed the Diabetic Eye Screening Study (DESS)to examine the feasibility and short-term effectiveness of nonmydriatic diabetic retinopathy (DR) screening for adults with diabetes in community-based settings. Methods: Study enrollment began in December 2011 at four sites: an internal medicine clinic at a county hospital in Birmingham, Alabama; a Federally-qualified community healthcare center in Miami-Dade County, Florida; a university-affiliated outpatient pharmacy in Philadelphia, Pennsylvania; and a medical home in Winston-Salem, North Carolina. People 18 years or older with previously diagnosed diabetes were offered free DR screening using non-mydriatic retinal photography that was preceded by a brief questionnaire addressing demographic information and previous eye care use. Visual acuity was also measured for each eye. Images were evaluated at a telemedicine reading center by trained evaluators using the National Health System DR grading classification. Participants and their physicians were sent screening report results and telephoned for a followup survey 3 months post-screening to determine whether participants had sought follow-up comprehensive eye care and their experiences with the screening process. Results: Target enrolment at each site was a minimum of 500 persons. Three of the four sites met this enrolment goal.

Conclusion: The INSIGHT/DESS is intended to establish the feasibility and short-term effectiveness of DR screening using non-mydriatic retinal photography in persons with diabetes who seek services in community-based clinic and pharmacy settings.

Martinez-Millana, Aet al (2015) Performance assessment of a closed loop system for diabetes management46

Telemedicine systems can play an important role in the management of diabetes, a chronic condition that is increasing worldwide. Evaluations on the consistency of information across these systems and on their performance in a real situation are still missing. This paper presents a remote monitoring system for diabetes management based on physiological sensors, mobile technologies and patient/doctor applications over a service-oriented architecture that has been evaluated in an international trial [83,905 operation records]. The proposed system integrates three types of running environments and data engines in a single service-oriented architecture. This feature is used to assess key performance indicators comparing them with other type of architectures. Data sustainability across the applications has been evaluated showing better outcomes for full integrated sensors. At the same time, runtime performance of clients has been assessed spotting no differences regarding the operative environment.

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