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      Rethinking Models of Outpatient Specialist Care in Type 2 Diabetes Using eHealth: Study Protocol for a Pilot Randomised Controlled Trial

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          Abstract

          Conventional outpatient services are unlikely to meet burgeoning demand for diabetes services given increasing prevalence of diabetes, and resultant impact on the healthcare workforce and healthcare costs. Disruptive technologies (such as smartphone and wireless sensors) create an opportunity to redesign outpatient services. In collaboration, the Department of Diabetes and Endocrinology at Brisbane Princess Alexandra Hospital, the University of Queensland Centre for Health Services Research and the Australian e-Health Research Centre developed a mobile diabetes management system (MDMS) to support the management of complex outpatient type 2 diabetes mellitus (T2DM) adults. The system comprises of a mobile App, an automated text-messaging feedback and a clinician portal. Blood glucose levels (BGL) data are automatically transferred by Bluetooth-enabled glucose meter to the clinician portal via the mobile App. The primary aim of the study described here is to examine improvement in glycaemic control of a new model of care employing MDMS for patients with complex T2DM attending a tertiary level outpatient service. A two-group, 12-month, pilot pragmatic randomised control trial will recruit 44 T2DM patients. The control group will receive routine care. The intervention group will be supported by the MDMS enabling the participants to potentially better self-manage their diabetes, and the endocrinologists to remotely monitor BGL and to interact with patients through a variety of eHealth modalities. Intervention participants will be encouraged to complete relevant pathology tests, and report on current diabetes management through an online questionnaire. Using this information, the endocrinologist may choose to reschedule the appointment or substitute it with a telephone or video-consultation. This pilot study will guide the conduct of a large-scale study regarding the capacity for a new model of care. This model utilises multimodal eHealth strategies via the MDMS to primarily improve glycaemic control with secondary aims to improve patient experience, reduce reliance on physical clinics, and decrease service delivery cost.

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          IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040.

          To produce current estimates of the national, regional and global impact of diabetes for 2015 and 2040.
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            Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews

            Background Diabetes is a common chronic disease that places an unprecedented strain on health care systems worldwide. Mobile health technologies such as smartphones, mobile applications, and wearable devices, known as mHealth, offer significant and innovative opportunities for improving patient to provider communication and self-management of diabetes. Objective The purpose of this overview is to critically appraise and consolidate evidence from multiple systematic reviews on the effectiveness of mHealth interventions for patients with diabetes to inform policy makers, practitioners, and researchers. Methods A comprehensive search on multiple databases was performed to identify relevant systematic reviews published between January 1996 and December 2015. Two authors independently selected reviews, extracted data, and assessed the methodological quality of included reviews using AMSTAR. Results Fifteen systematic reviews published between 2008 and 2014 were eligible for inclusion. The quality of the reviews varied considerably and most of them had important methodological limitations. Focusing on systematic reviews that offered the most direct evidence, this overview demonstrates that on average, mHealth interventions improve glycemic control (HbA1c) compared to standard care or other non-mHealth approaches by as much as 0.8% for patients with type 2 diabetes and 0.3% for patients with type 1 diabetes, at least in the short-term (≤12 months). However, limitations in the overall quality of evidence suggest that further research will likely have an important impact in these estimates of effect. Conclusions Findings are consistent with clinically relevant improvements, particularly with respect to patients with type 2 diabetes. Similar to home telemonitoring, mHealth interventions represent a promising approach for self-management of diabetes.
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              T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis

              Background Mobile health interventions (mHealth) based on smartphone applications (apps) are promising tools to help improve diabetes care and self-management; however, more evidence on the efficacy of mHealth in diabetes care is needed. The objective of this study was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing the effect of mHealth apps on changes in hemoglobin A1c (HbA1c), blood glucose, blood pressure, serum lipids, and body weight in type 2 diabetes mellitus (T2DM) patients. Methods Two independent reviewers searched three online databases (PubMed, the Cochrane Library, and EMBASE) to identify relevant studies published between January 2005 and June 2016. Of the 2,596 articles retrieved, 13 RCTs were included. We used random effects model to estimate the pooled results. Results Thirteen studies were selected for the systematic review, six of which with data available containing 1,022 patients were included for the meta-analysis. There was a moderate effect on glycemic control after the mHealth app-based interventions. The overall effect on HbA1c shown as mean difference (MD) was -0.40% (-4.37 mmol/mol) (95% confidence interval [CI] -0.69 to -0.11% [-7.54 to -1.20 mmol/mol]; p = 0.007) and standardized mean differences (SMD) was -0.40% (-4.37 mmol/mol) (95% confidence interval [CI] -0.69 to -0.10% [-7.54 to -1.09 mmol/mol]; p = 0.008). A subgroup analysis showed a similar effect with -0.33% (-3.61 mmol/mol) (95% CI -0.59 to -0.06% [-6.45 to -0.66 mmol/mol]; p = 0.02) in MD and -0.38% (-4.15 mmol/mol) (95% CI -0.71 to -0.05% [-7.76 to -0.55 mmol/mol]; p = 0.02) in SMD in studies where patients’ baseline HbA1c levels were less than 8.0%. No effects of mHealth app interventions were found on blood pressure, serum lipids, or weight. Assessment of overall study quality and publication bias demonstrated a low risk of bias among the six studies. Conclusions Smartphone apps offered moderate benefits for T2DM self-management. However, more research with valid study designs and longer follow-up is needed to evaluate the impact of mHealth apps for diabetes care and self-management.
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                Author and article information

                Journal
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                ijerph
                International Journal of Environmental Research and Public Health
                MDPI
                1661-7827
                1660-4601
                18 March 2019
                March 2019
                : 16
                : 6
                : 959
                Affiliations
                [1 ]Centre for Health Services Research, Faculty of Medicine, Brisbane, The University of Queensland, QLD 4102, Australia; f.fatehi@ 123456uq.edu.au (F.F.); d.bird@ 123456uq.edu.au (D.B.); len.gray@ 123456uq.edu.au (L.G.)
                [2 ]Department of Diabetes and Endocrinology, Princess Alexandra Hospital, Woolloongabba, Brisbane, QLD 4102, Australia; Anthony.Russell2@ 123456health.qld.gov.au
                [3 ]CSIRO Australian e-Health Research Centre, Brisbane, QLD 4102, Australia; Mohan.Karunanithi@ 123456csiro.au
                [4 ]School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran 14174, Iran
                [5 ]School of Public Health, The University of Queensland, Brisbane, QLD 4006, Australia; d.darssan@ 123456uq.edu.au
                [6 ]Faculty of Medicine, The University of Queensland, Brisbane, QLD 4102, Australia
                Author notes
                [* ]Correspondence: anish.menon@ 123456uq.net.au
                Author information
                https://orcid.org/0000-0002-8176-0292
                https://orcid.org/0000-0001-9888-1966
                https://orcid.org/0000-0001-7050-9150
                http://orcid.org/0000-0002-9141-932X
                https://orcid.org/0000-0001-7886-8844
                https://orcid.org/0000-0003-2141-0802
                Article
                ijerph-16-00959
                10.3390/ijerph16060959
                6466144
                30889802
                871011bd-af0b-470a-9e8a-414183db1308
                © 2019 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 21 February 2019
                : 12 March 2019
                Categories
                Protocol

                Public health
                diabetes,models of care,insulin dose adjustment,mhealth,ehealth,digital health,telemedicine,telehealth

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