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      Web-based support for individuals with type 2 diabetes - a feasibility study

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          Abstract

          Background

          Self-care is one of the cornerstones in the treatment of type 2 diabetes. Patients with type 2 diabetes struggle to maintain acceptable levels of blood sugar, blood pressure and lipids, the fundamental for the prevention of macro- and microvascular as well as neuropathic complications. The primary aim of the study was to evaluate the feasibility and describe patients’ and caregivers’ experiences of using the web- and smartphone-based system Triabetes. The secondary aim was to investigate if the use of the system could improve patients’ clinical outcomes.

          Methods

          Feasibility was assessed with describing recruitment rate and the participant´s views of using the system. Laboratory and anthropometry data were also collected.

          Results

          The study showed that recruitment of patients to participate in the intervention was limited and compliance to the study protocol was low. A majority of the patients stated that the system was easy to get an overview of and that the system motivated them and made it easier and fun to handle lifestyle habits. A secondary finding of the study was that there was a significant lowering of LDL values.

          Conclusions

          Feasibility in terms of recruitment rate was low. The participants agreed that the application overall was useful but suggested several improvements. Summarized lessons learned from this study are following: (1) we need more knowledge about what motivates a person to use a digital tool for a longer period of time; (2) the tool must be easy and less time consuming to use; (3) the technical structure needs to be improved and automatic recording of data must be improved.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12913-021-06707-7.

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          Most cited references25

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          Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies

          Summary Background Uncertainties persist about the magnitude of associations of diabetes mellitus and fasting glucose concentration with risk of coronary heart disease and major stroke subtypes. We aimed to quantify these associations for a wide range of circumstances. Methods We undertook a meta-analysis of individual records of diabetes, fasting blood glucose concentration, and other risk factors in people without initial vascular disease from studies in the Emerging Risk Factors Collaboration. We combined within-study regressions that were adjusted for age, sex, smoking, systolic blood pressure, and body-mass index to calculate hazard ratios (HRs) for vascular disease. Findings Analyses included data for 698 782 people (52 765 non-fatal or fatal vascular outcomes; 8·49 million person-years at risk) from 102 prospective studies. Adjusted HRs with diabetes were: 2·00 (95% CI 1·83–2·19) for coronary heart disease; 2·27 (1·95–2·65) for ischaemic stroke; 1·56 (1·19–2·05) for haemorrhagic stroke; 1·84 (1·59–2·13) for unclassified stroke; and 1·73 (1·51–1·98) for the aggregate of other vascular deaths. HRs did not change appreciably after further adjustment for lipid, inflammatory, or renal markers. HRs for coronary heart disease were higher in women than in men, at 40–59 years than at 70 years and older, and with fatal than with non-fatal disease. At an adult population-wide prevalence of 10%, diabetes was estimated to account for 11% (10–12%) of vascular deaths. Fasting blood glucose concentration was non-linearly related to vascular risk, with no significant associations between 3·90 mmol/L and 5·59 mmol/L. Compared with fasting blood glucose concentrations of 3·90–5·59 mmol/L, HRs for coronary heart disease were: 1·07 (0·97–1·18) for lower than 3·90 mmol/L; 1·11 (1·04–1·18) for 5·60–6·09 mmol/L; and 1·17 (1·08–1·26) for 6·10–6·99 mmol/L. In people without a history of diabetes, information about fasting blood glucose concentration or impaired fasting glucose status did not significantly improve metrics of vascular disease prediction when added to information about several conventional risk factors. Interpretation Diabetes confers about a two-fold excess risk for a wide range of vascular diseases, independently from other conventional risk factors. In people without diabetes, fasting blood glucose concentration is modestly and non-linearly associated with risk of vascular disease. Funding British Heart Foundation, UK Medical Research Council, and Pfizer.
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            CONSORT 2010 statement: extension to randomised pilot and feasibility trials

            The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.
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              Diabetes and cardiovascular disease. The Framingham study.

              Based on 20 years of surveillance of the Framingham cohort relating subsequent cardiovascular events to prior evidence of diabetes, a twofold to threefold increased risk of clinical atherosclerotic disease was reported. The relative impact was greatest for intermittent claudication (IC) and congestive heart failure (CHF) and least for coronary heart disease (CHD), which was, nevertheless, on an absolute scale the chief sequela. The relative impact was substantially greater for women than for men. For each of the cardiovascular diseases (CVD), morbidity and mortality were higher for diabetic women than for nondiabetic men. After adjustment for other associated risk factors, the relative impact of diabetes on CHD, IC, or stroke incidence was the same for women as for men; for CVD death and CHF, it was greater for women. Cardiovascular mortality was actually about as great for diabetic women as for diabetic men.
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                Author and article information

                Contributors
                marina.taloyan@ki.se , marina.taloyan@sll.se
                Journal
                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                22 July 2021
                22 July 2021
                2021
                : 21
                : 721
                Affiliations
                [1 ]Academic Primary Care Center, Region Stockholm, Stockholm, Sweden
                [2 ]GRID grid.4714.6, ISNI 0000 0004 1937 0626, Dept of Neurobiology Care Sciences and Society, Division of Family Medicine and Primary Care, , Karolinska Institutet, ; Alfred Nobels allé 23, SE-14183 Huddinge, Sweden
                [3 ]Capio Solna Primary Health Care Center, Region Stockholm Stockholm, Sweden
                [4 ]Capio Väsby Primary Health Care Center, Region Stockholm Stockholm, Sweden
                [5 ]GRID grid.8993.b, ISNI 0000 0004 1936 9457, Department of Public Health and Caring Sciences, Section of General Medicine, , Uppsala University, ; Uppsala, Sweden
                [6 ]Research and Development Unit for the Elderly, FOU nu, Region Stockholm Stockholm, Sweden
                [7 ]GRID grid.465198.7, Departement of Neurobiology Care Sciences and Society, Division of Physiotherapy, , Karolinska Institutet, ; Solna, Sweden
                [8 ]GRID grid.24381.3c, ISNI 0000 0000 9241 5705, Karolinska University Hospital, Women’s Health and Allied Health Professional Theme, Medical Unit Occupational therapy and Physiotherapy, ; Solna, Sweden
                Article
                6707
                10.1186/s12913-021-06707-7
                8295635
                34294112
                54fc39e1-06e5-48e0-b0a9-d09f70390a9d
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 20 October 2020
                : 28 June 2021
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100004348, Stockholms Läns Landsting;
                Award ID: 20151020
                Award Recipient :
                Funded by: Karolinska Institute
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2021

                Health & Social care
                type 2 diabetes,web-based support,feasibility
                Health & Social care
                type 2 diabetes, web-based support, feasibility

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