Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus

BackgroundSelf-management of Type 2 diabetes mellitus (T2D) is challenging. Regular self-monitoring of blood glucose and healthy lifestyles are required to improve glycometabolic control, thus delaying diabetes complications, and reducing hospitalizations. Digital technologies can empower patients in their disease management promoting self-management and motivation to change behaviors. We report the results of an exploratory trial aimed at evaluating the metabolic outcomes of using digital solutions for T2D self-management developed in the ProEmpower project, a European Commission funded Pre-Commercial Procurement.MethodsTwo digital solutions, DM4All and DiaWatch, which were codesigned with providers, patients, and caregivers, enabled the collection of clinical parameters by the patient using a smartphone integrated with the medical devices (glucometer, sphygmomanometer, scale, smart watch for heart rate monitoring and step counter). Data were automatically sent to the shared care plan allowing professionals to monitor adherence to treatment, set goals, and communicate more effectively with patients. At baseline and after an average follow-up of 8 months, glycosylated hemoglobin (HbA1c), body weight, blood pressure, and blood lipids were measured in 100 T2D patients using the ProEmpower solutions across different diabetes centers in Campania Region, age 45–79  years, both genders, and compared with a Control cohort of T2D patients (n = 100) with similar clinical characteristics and followed for a comparable period of observation in the same centers.ResultsAt baseline, the ProEmpower participants and the Control subjects were on average overweight, with a similar BMI in the two cohorts, and mean HbA1c was at acceptable levels (around 7.0%). After the 8 month exploratory trial, body weight, HbA1c, systolic and diastolic blood pressure, and plasma and LDL-cholesterol significantly decreased in the ProEmpower participants compared to baseline (p < 0.05 for all). The changes in systolic and diastolic blood pressure, and plasma and LDL-cholesterol were significantly different from those observed in the Control cohort (p < 0.05 for all).ConclusionThis pilot study showed positive effects on metabolic outcomes relevant to cardiovascular risk in T2D of adopting digital telemedicine self-monitoring solutions based on automation of measurements and coaching on healthy lifestyles promotion

An innovative approach for health care delivery to obese patients: from health needs identification to service integration

In Europe, more than half of the population is overweight or obese, and effort to design, validate, and implement innovative approaches is required to address social and health unmet needs of obese patients in terms of health promotion, disease prevention, and integration of services. The challenge is improving the collaboration between the different health and care stakeholders involved in the lives of obese patients, changing the socio-cultural attitude towards food intake and other behaviours leading to a negative impact on their health-related quality of life. The digital transformation of health and care can support changes in healthcare systems, healthy policy, and approaches to patient care and better implementation of the different health promotion and disease prevention strategies between all the stakeholders and support obese patients. Based on the previously experience adopted by Blueprint Partners with the Blueprint persona and user scenario in the context of models of care and prevention, health policies and analysis of risk factors affecting health and quality of life of obese subjects, the study aimed to simulate an integrated care pathway, through a multidisciplinary approach, developing and applying solutions and good clinical practices addressing the social and health unmet needs of obese patients. A pilot study assessed the quality of life (QoL), adherence to the Mediterranean diet, efficacy and interoperability of a digital health platform, Paginemediche. it. A qualitative approach has been adopted to identify and specify key digital solutions and high-impact user scenarios in Active and Healthy Ageing (AHA). To achieve a successful result, an iterative and collaborative approach has been followed to develop a user-centred perspective to the identification of solutions addressing health needs with different complexity along the entire life-course. Four initial key topic areas were chosen and used to identify different digital solutions that may meet the needs of the population segments defined by both age and the complexity of their health status. All data, derived from the industry representatives in the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA), were collected via a survey to how digital solutions best met the needs of the various population segments represented by personas. Subsequently, innovative solutions were designed based on how a user from a target group interacts with technologies, developing "personas" belonging to specific "population segments" with different conditions and needs. Then, a high-impact user scenario, based on the correlation of personas' needs, good clinical practices and digital solutions available targeting needs which playing a role in the health and care delivery for the persona, has been developed. In the end, to evaluate how digital solutions and technologies can support obese patients during their weight loss or management of their related comorbidities in current service provision, ten obese patients were enrolled to evaluate a Digital Health platform, pagininemediche.it, developed. Matilde, the Blueprint persona developed, highlighted some of the main needs (social support, development of a health-friendly environment and educational program on healthy nutrition and physical activity) that may be addressed by integrating innovative solutions in the care of obese patients. Based on her profile, a high-impact user scenario diagram correlates health and social needs with digital solutions and can help key actors in the creation of a well-integrated care approach. Moreover, the evaluation of the digital platform, paginemediche.it, demonstrated how digital solutions can motivate and support obese patients in changing habits towards a healthy lifestyle, although no further statistical significance has been identified in the quality of life assessment because of the limited number of the patients, and short period of observation. Overweight or obese patients tend to be marginalized and the subject of a real social stigma. Digital solutions may be useful to overcome psychological factors that prevent obese patients from starting their journey for a lifestyle change. The suggested approach, which considers health needs, IT skills, socioeconomic context, interoperability, and integration gaps that may influence the adoption of innovative solutions tailored to improve health outcomes is person-centred, and identify what is important for obese patients. The implementation of a persona and user scenario approach may also be useful for the early involvement of end-users in solutions' design and adaptation, increasing adherence, and the effectiveness of digital solutions. Persona profiles, the user scenario, and the related digital solution also consider the potential benefits that can derive for both patients and health system in term of reduced emergency room admissions, waiting lists, and health related expenditures

An innovative approach to designing digital health solutions addressing the unmet needs of obese patients in Europe

According to the World Health Organization (WHO), the worldwide obesity rate has tripled since 1975. In Europe, more than half of the population is overweight and obese. Around 2.8 million people die each year worldwide as a result of conditions linked to being overweight or obese. This study aimed to analyze the policies, approaches, and solutions that address the social and health unmet needs of obese patients, at different levels, in order to simulate the definition of an integrated approach, and to provide and share examples of innovative solutions supporting health promotion, disease prevention, and integration of services to improve the collaboration between the different health and care stakeholders involved across the country and in the lives of obese patients. A collaborative approach involving various levels of government and regional experts from different European countries was applied to identify, explore, and evaluate different aspects of the topic, from the innovation perspective and focusing on a European and a regional vision. Currently, people prefer more foods rich in fats, sugars, and salt/sodium than fruits, vegetables, and fiber. This behavior leads to a significant negative impact on their health-related quality of life. Changes in healthcare systems, healthy policy, and approaches to patient care and better implementation of the different prevention strategies between all the stakeholders are needed, taking advantage of the digital transformation of health and care. Such changes can support obese patients in their fight against an unhealthy lifestyle and at the same time reduce healthcare costs

Effective implementation and monitoring of telehealth and telecare in Ireland: learning from international best practice.

This document synthesises the information provided in a number of papers relating to Telecare/Telehealth commissioned by and developed for the National Disability Authority between 2014 and 2017. The papers in question were developed by researchers in Work Research Centre (WRC), the National Disability Authority and the University of Ulster, and this report has taken key learning and information from each of them to create this composite briefing paper

Information and communication technologies and patient empowerment: A complex skein

This article aims to explore the relationship between patient empowerment and information and communication technologies (ICTs). Indeed, ICTs are considered important for increasing access to medical information and for patients\u2019 other experiences, thereby nourishing the empowering rhetoric. The paper presents a research study conducted in Italy that focuses on the self-assessments made by online health communities (OHCs) users, subdivided in three categories, according to their level of online activity: Lurkers, occasionally active users and frequently active users. The concept of empowerment was operationalised in five issues: autonomy from doctors, involvement in medical decision-making, competence, self-management and acceptance. The results support the relationship between perceptions of empowerment and the higher level of activity played on OHCs, contributing instead to reject the idea of a generalised benefit. Moreover, the paper aims to enrich the theory of patient empowerment by adding a socio-material perspective. This helps broaden the understanding of the relationship between empowerment and ICTs by highlighting its underlying complex skein

Social, Technological and Health Innovation: Opportunities and Limitations for Social Policy, Health Policy, and Environmental Policy

This Research Topic focuses on both strengths and weaknesses of social innovation, technological innovation, and health innovation that are increasingly recognized as crucial concepts related to the formulation of responses to the social, health, and environmental challenges. Goals of this Research Topic: (1) to identify and share the best recent practices and innovations related to social, environmental and health policies; (2) to debate on relevant governance modes, management tools as well as evaluation and impact assessment techniques; (3) to discuss dilemmas in the fields of management, financing, designing, implementing, testing, and maintaining the sustainability of innovative models of delivering social, health and care services; and (4) to recognize and analyze social, technological and health innovation that has emerged or has been scaled-up to respond to crisis situations, for example, a pandemic of the COVID-19 coronavirus disease

Medical software certification processes in Europe, USA and Brazil

Dissertação de Mestrado Integrado em Engenharia Biomédica apresentada à Faculdade de Ciências e Tecnologia da Universidade de Coimbra.Actualmente o software médico é um mercado em crescimento contínuo. É essencial para um fabricante deste tipo de produto médico seguir os requisitos regulamentares obrigatórios e implementar as medidas necessárias na empresa para poder comercializar o seu produto em países diferentes. O produto médico a ser certificado é o OneCare Sensing comercializado pela ISA-Intellicare, uma solução de software de monitorização destinado a recolher, armazenar, visualizar, transmitir e fornecer alertas de parâmetros fisiológicos como temperatura, níveis de glucose e pressão sanguínea e oximetria de pulso dos utilizadores em sua casa permitindo a monitorização à distancia de familiares ou clínicos, reduzindo as suas deslocações a estabelecimentos de saúde ou visitas médicas familiares. O objectivo desta tese é recolher e analisar os requesitos regulamentares deste software médico na Europa, Brazil e EUA. Relativamente à Europa foi realizado um trabalho mais prático implementando na empresa todos os requisitos necessários para obter marcação CE seguindo a Directiva Médica 93/42/EEC. Nos EUA é necessária a autorização da FDA preenchendo uma submissão 510(k) e implementando um sistema de gestão de qualidade de acordo com FDA QSR – 21CFR Parte 820. Relativamente ao Brasil, a agência reguladora é a ANVISA e o tipo de submissão para este dispositivo é o registro. Tambem é necessário implementar um sistema de gestão de qualidade de acordo com GBMP na empresa. Foi descoberto que estas regiões apesar de possuirem requisitos regulatórios independentes possuem algumas semelhanças entre si. Este estudo permite que o produto em questão fique um passo mais próximo de ser comercializado na Europa, Brazil e EUA. Palavras-chave: software médico, dispositivo médico, processo de certificação, marcação CE, directiva 93/42/EEC, autorização da FDA, registro ANVISA, requisitos regulamentares na Europa, EUA e Brasil

Front-Line Physicians' Satisfaction with Information Systems in Hospitals

Day-to-day operations management in hospital units is difficult due to continuously varying situations, several actors involved and a vast number of information systems in use. The aim of this study was to describe front-line physicians' satisfaction with existing information systems needed to support the day-to-day operations management in hospitals. A cross-sectional survey was used and data chosen with stratified random sampling were collected in nine hospitals. Data were analyzed with descriptive and inferential statistical methods. The response rate was 65 % (n = 111). The physicians reported that information systems support their decision making to some extent, but they do not improve access to information nor are they tailored for physicians. The respondents also reported that they need to use several information systems to support decision making and that they would prefer one information system to access important information. Improved information access would better support physicians' decision making and has the potential to improve the quality of decisions and speed up the decision making process.Peer reviewe