key: cord-0966055-u7eikeu2 authors: Tejera, Cristina; Moreno-Pérez, Óscar; Rios, Jose; Reyes-García, Rebeca title: People living with Type 1 diabetes point of view in COVID-19 times (COVIDT1 Study): disease impact, health system pitfalls and lessons for the future() date: 2020-12-03 journal: Diabetes Res Clin Pract DOI: 10.1016/j.diabres.2020.108547 sha: edbf23e35852179d7c91b1cd1d526668a87cf22a doc_id: 966055 cord_uid: u7eikeu2 AIMS: To analyse the effects of confinement among people with type 1 diabetes (T1D) and their caregivers over the course of the COVID-19 crisis and to evaluate contemporary changes in medical assistance and patient preferences. METHODS: An observational cross-sectional study designed as a self-reported web-based survey was conducted over the course of the COVID-19 pandemic. RESULTS: A total of 769 subjects participated in the survey (603 people with T1D and 166 caregivers). Changes in glycaemic control were reported in 66% of cases, weight gain in 40.4% of cases and decreased exercise levels in 65.4% of cases. Of the cohort, 53% maintained contact with the healthcare team, and 23% received specific information related to COVID-19. Emotional support was requested by 17% of respondents. Regarding telemedicine, 97.9% agreed with its use with the following preferences regarding the future: telephone call (84.5%), video-call (60.6%) and platform devices (39.7%). CONCLUSIONS: Over the course of the COVID-19 pandemic, at least two-thirds of people with T1D underwent changes in the management of their condition. Almost all participants agreed with the concept of telemedicine, favouring telephone and video calls as their preferred means of communication. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have nothing to disclose The rapid spread of the novel coronavirus disease 2019 , caused by SARS-CoV-2, throughout the world quickly turned into a pandemic. The COVID-19 outbreak caused a global health crisis with significant potential impact on people with chronic diseases 1 . It is well known that both people with type 1 diabetes mellitus (T1D) and those with type 2 diabetes mellitus (T2D) are exposed to an increased risk of infection and a greater number of associated complications. In the context of COVID-19, people living with diabetes (PLWD) are at risk of rapid progression and worse disease outcomes 2 3 . Recently, Barrón and colleagues published an adjusted odds ratio of dying of COVID-19 in hospital of 2•86 in people with T1D and 1•81 in those with T2D compared to those without diabetes 4 . Other major comorbidities related to COVID-19 severity are advanced age, hypertension, cardiovascular disease, smoking, and obesity 3 . However, conflicting evidence has emerged regarding the risk of SARS-CoV-2 infection among people with diabetes 2 5 . Adding to the confinement situation and the subsequent restriction of hospital visits, this conflicting health information has increased concerns among PLWD. Public health regulations and governmental measures adopted during the COVID-19 pandemic have enforced restrictions on day-to-day life, including isolation and home confinement. The impacts of these restrictions on health behaviour and lifestyle at home are as yet undefined. While we have increasing amounts of data on hospitalized diabetes patients, both in the general ward and in critical care units 1, 6 , the real impact of the pandemic on people with diabetes and their caregivers staying at home during the confinement period has not been fully defined. Regarding glycaemic control, in T1D, using flash glucose monitoring, glycaemic control improved in those who stopped working during the lockdown in Italy 7 . In Spain 8, 9 , despite the limitations of lockdown, glycaemic control improved in patients with T1D, suggesting that having more time for self-management may help improve glycaemic control in the short term. The current COVID-19 pandemic provides an incentive to expand the use of telemedicine in relation to diabetes care, especially with regard to the management of T1D 10 . A better understanding of the barriers faced by digital diabetes care and the identification of unmet needs for PLWD may offer critically important approaches to improve this evolving technology in a safe, effective, and cost-efficient manner 11 . In recent months, many efforts and initiatives have been developed to adapt the care of PLWD to the current situation. As an example, in Italy, a joint telemedicine effort was made to have diabetologists available 7/7 days to take turn for on-line advice for drug dosage adaptation needs or any other remotely manageable medical emergencies. As the authors stated, "this crisis has to be taken as a real chance to rethink our own lives, thus turning into moral, social and scientific rebirth for the entire hard-hearted world of today" 12 . Moreover, in many diabetes clinics, there has been a rapid adaptation to telemedicine, about which individual experiences have been communicated 13, 14, 15 . However, with current evidence, we believe that the effects of confinement, beyond glycaemic control, and in all PLWD (not just those using flash glucose monitoring) deserve to be better characterized. Furthermore, despite personal experiences having been published by various diabetes experts, the opinion of people with diabetes regarding these changes and their future wishes is also of undoubted interest. The objective of this study was to analyse the effects of home confinement on PLWD type 1 and their caregivers. In addition, we evaluated medical assistance changes that have occurred during this sanitary crisis and patient preferences regarding the use of telemedicine in the near future. These lessons will help us turn this crisis into an opportunity by proposing efficient patient-centred care measures to scientific societies leading diabetes care and health systems to help people with diabetes. This was an observational cross-sectional study designed as a web-based survey. The web-based survey was conducted in Spanish through social networks (Twitter, Instagram, Facebook and LinkedIn). People with any type of diabetes or their caregivers were invited to participate. All data were selfreported. The survey was conducted between April 26 th and May 3 rd May 2020 during the COVID-19 pandemic (see figure 1 to place the timing of the survey in the context of the epidemiological curve). In Spain, the confinement period began on March 15 th , during which only essential workers were allowed to work and basic-needs purchases could be made. On April 26 th , children under the age of 14 were allowed to leave the house for 1 hour each day provided they were accompanied by an adult, and from May 2, the entire population was allowed to go out for 1 hour every day, staggered by age group. The inclusion criteria were people with any type of diabetes (type 1 diabetes, type 2 diabetes, MODY, LADA, gestational diabetes, diabetes secondary to pancreatic insufficiency) or those caring for a person with any type of diabetes. A total of 898 PLWD and caregivers completed the survey. In this paper, we present data pertaining to people with T1D and their caregivers, representing the majority of the participants (85.6%). The study protocol was in accordance with the Helsinki Declaration (October 2013) and the basic principles of Good Clinical Practice. Information about the survey was provided to potential participants, who were also offered the possibility of contacting the investigative team. The completion of the survey and return of the data were provided by implied consent. The participants did not receive any form of payment for their collaboration in the survey. Given the prevalence of diabetes in Spain, for a confidence interval of 95% and a margin of error of 5%, we calculated that the sample size should be at least 385 people. Considering the Spanish T1D population, which stands at 90,000 individuals, the sample size for the PLWD type 1 subpopulation would have to be at least 383. The investigators developed a survey comprising 34 questions (Appendix 1). The The sample size was calculated based on the analysis plan and to ensure that comparisons could be made across groups. Continuous variables were expressed as means and standard deviations, and categorical variables were expressed as percentages. The T-test was used to compare means between two groups. An association study was performed between categorical variables using the chi-square test. The magnitude of the association between the variables explaining weight variations and requests for emotional support among the T1D subpopulation were analysed using a univariate logistic regression model. A total of 769 subjects completed the survey, 603 PLWD type 1 and 166 caregivers. General characteristics of the survey cohort are shown in Table 1, including employment status and usual healthcare. Basic purchases during lockdown were carried out by PLWD themselves in 46.2% of cases (56.7% of people with T1D and 7.8% by caregivers). Changes in glycaemic control, physical activity and other diabetes-related aspects and difficulties during lockdown are summarized in Table 2 When analysing these items, certain differences were identified between people with T1D and their caregivers. During the quarantine period, caregivers reported higher glycaemic control than usual, higher insulin requirements and less exercise. Furthermore, no weight changes were reported for a higher percentage of caregivers when compared to people with T1D. When queried about difficulties during lockdown, more people with T1D reported having had difficulties with glycaemic control when compared to caregivers ( Table 2) . Only 23% of survey participants expressed having received information related to COVID-19 from their healthcare providers. By contrast, 79% of the sample expressed an interest in receiving this information. In order of relevance, non-healthcare information channels used were as follows: Telemedicine results and preferences for the near future are summarized in Two recent studies in Spain in PLWT1D using FGM reported no deterioration in glycaemic control resulting from the lockdown enforced as a result of the COVID-19 pandemic 8, 9 . However, this study was conducted using a smaller portion of the population using FGM; therefore, the results may not be applicable to the global population of people with T1D. Emotional support was requested by 17% of the individuals surveyed. Considering a unique pathological entity, diabetes-related distress is frequently linked to diabetes (18-45%), and therefore, its routine evaluation is recommended in caring for PLWD 18 Telehealth may make the delivery of diabetes care more patient-driven and patient-centred. Telemedicine in diabetes has shown to improve selfmanagement, to provide educational requirements and to improve patient healthrelated quality of life 21 , as well as to reduce diabetes-related distress among young people with T1D 22 . Additionally, it may reduce costs and improve access to the healthcare system 23 . Where glycaemic control is concerned, a metaanalysis of randomized controlled trials showed few changes in glycaemic control 21 24 25 and no effects related to an increased risk of hypoglycaemia 21 . Studies carried out over a more extended period of time (more than 6 months) were associated with more serious effects 24 . Furthermore, previous results regarding telemedicine may not be applicable to the current situation. The deep changes undergone not only in terms of medical assistance but also by society as a whole may bring about improvements in the performance of telemedicine within this new context. Additionally, the implementation of telehealth reduces overcrowding in health centres, consequently lowering infection and death rates. Almost all survey subjects agreed with the possibility of using telemedicine. Telephone contact was frequently used during this crisis and turned out to be the preferred method for telemedicine. However, video calls were seldom used during the health crisis, despite being selected as the second preferred option. Similarly, platform devices were used in less than one in five telemedicine visits, this option ranking third by respondents. Nevertheless, the preferences and expectations of users represent key aspects for success in terms of the future development of telemedicine related to diabetes. The COVID-19 crisis has brought to light a number of challenges and opportunities regarding global health management and, more specifically, the management of diabetes. We are faced with the opportunity to adopt digital technologies to improve the quality and reduce the costs of healthcare services and perhaps even to improve access to healthcare while increasing adherence to medical visits 26 . The identification of patient preferences regarding telemedicine may improve adherence. Over the course of the crisis, we were able to identify certain pitfalls in diabetes care, one of the main learnings derived from the COVIDT1 study. This study presents certain limitations that should be taken into consideration. First, all survey data were self-reported, so reporting accuracy could be a concern, as recall bias may have influenced the results. Second, according to the Spanish official data protection law, no data about sex were recorded, and thus, potential differences according to sex could not be evaluated. In addition, as with most studies based on internet surveys, data may be affected by selection bias. People who had access to the internet survey were more likely to present higher intellectual levels, access to the internet and to be more concerned about their disease. Finally, the respondents' diabetes diagnoses were not confirmed by a physician, and some of the respondents might have inaccurately reported a diabetes diagnosis, diabetes type, etc. However, due to differences in access to resources and educational programmes between T1DM and T2DM in Spain, incorrect identification of PLWT1D is unlikely. Over the course of the COVID-19 pandemic, people with T1D suffered from diabetes management issues that affected their daily lives. Lockdown caused significant consequences affecting their weight, eating habits and exercise and glycaemic control, negatively impacting the health of PLWD. Almost all respondents agreed with the concept of telemedicine, with telephone and video calls being the preferred means of communication. We anticipate many opportunities for further developing the virtual care model. PLWD type 1 reported their acceptance of and brought to light a need for telemedicine-enabled solutions, which has opened a window to further deploy the model in a system that has traditionally preferred face-to-face contact. The identification of PLWD type 1 preferences regarding a telemedicine health strategy in the COVIDT1 study has laid the groundwork for improved diabetes management in a safe, effective, and cost-efficient manner in the near future. The authors declare no conflict of interest. The authors received no funding from an external source. contact with the medical team during the crisis (no, orange spot), telematic agree and preference channels, emotional request, age, and BMI. The multifactorial analysis shows internal consistency due to the grouping of categories into already known variables (changes in glucose / changes in treatment) (gray arrows). 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