Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial.

BACKGROUND: With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluate the efficacy of a behavioral intervention model delivered through a smart speaker on mental health and diabetes self-care in the elderly with diabetes. METHODS: This is a single-center, pragmatic, parallel two-arm open randomized clinical trial involving elderly patients with type 2 diabetes. We plan to enroll a total of 112 individuals who will be randomized 1:1 to receive the Smart Speaker EchoDot 3rd Gen device (Amazon Echo®) for home use (intervention arm) or to maintain usual care (control arm). The primary outcome is mental distress, assessed using the 20-item Self Reporting Questionnaire (SRQ-20) after a 12-week intervention period. Secondary outcomes include quality of life, adherence to diabetes self-care behaviors, perception of stress, glycemic control, blood pressure, and lipid profile. Analysis of covariance (ANCOVA) will be used to evaluate the effects of the intervention on the outcomes. DISCUSSION: This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023.

Obesity bias: How can this underestimated problem affect medical decisions in healthcare? A systematic review.

INTRODUCTION: Obesity is often labeled as a physical characteristic of a patient rather than a disease and it is subject to obesity bias by health providers, which harms the equality of healthcare in this population. OBJECTIVE: Identifying whether obesity bias interferes in clinical decision-making in the treatment of patients with obesity. METHODS: A systematic review of observational studies published between 1993 and 2023 in MEDLINE, Embase, and Cochrane Library on obesity bias and therapeutic decisions was carried out. The last search was conducted on June 30, 2023. The main outcome was the difference between clinical decisions in the treatment of individuals with and without obesity. The Newcastle-Ottawa scale for observational studies was used to assess for quality. After the selection process, articles were presented in narrative and thematic synthesis categories to better organize the descriptive analysis. RESULTS: Of the 2546 records identified, 13 were included. The findings showed fewer screening exams for cancer in patients with obesity, who were also susceptible to less frequent pharmacological treatment intensification in the management of diabetes. Women with obesity received fewer pelvic exams and evidence of diminished visual contact and physician confidence in treatment adherence was reported. Some studies found no disparities in treatment for abdominal pain and tension headaches between patients presented with and without obesity. CONCLUSION: The presence of obesity bias has negative effects on medical decision-making and on the quality of care provided to patients with obesity. These findings reveal the urgent necessity for reflection and development of strategies to mitigate its adverse impacts. (The protocol was registered with the international prospective register of systematic reviews, PROSPERO, under the number CRD42022307567).

Adjusting to the "new normal": How were mental health and self-care affected in patients with diabetes mellitus 1 year into the COVID-19 crisis? A longitudinal study.

This study aimed to assess the long-term effect of the pandemic on mental health and self-care parameters in patients with diabetes during the COVID-19 pandemic in Brazil. After 18 months of pandemic, 118 participants remained in the study (mean age of 56.6 ± 13.4 years, 66.7% were women). We observed no change in the scores for mental health disorders screening. Regarding self-care, patients with type 1 diabetes showed an improvement in the adherence score compared to those found at the beginning of the pandemic (variation + 3.5 (-6.0 to +15.8) points, p = 0.02), and also compared to those with type 2 diabetes. Although the pandemic have negatively affected many people's mental health, especially in those with chronic diseases, our results show that patients with diabetes may have developed good coping and adaptive strategies to maintain diabetes control and symptom pattern of mental health disorders over the course of the pandemic.

Healthcare of pregnant women with diabetes during the COVID-19 pandemic: a Southern Brazilian cross-sectional panel data.

OBJECTIVES: To evaluate the indirect effects of the COVID-19 pandemic on the care of women with pregnancies complicated by gestational or pre-existing diabetes, and their maternal-fetal outcomes. METHODS: A cross-sectional panel data conducted in a University Hospital in Southern Brazil. Maternal-fetal outcomes and predictors of care from 235 pregnant women with type 1, type 2, or gestational diabetes were evaluated. Two time periods were compared: six months preceding the pandemic, in 2019, and the COVID-19 period from September 2020 to March 2021. Comparisons were performed using analysis of variance, Mann-Whitney U, Fisher's exact and T-tests. Risks were calculated using the Poisson regression with robust estimates. RESULTS: Maternal age was lower (32.1 ± 6.8 vs. 34.4 ± 6.6, p=0.009) and rates of depression/anxiety were higher (16.5 vs. 7.4%, p=0.046) in the group evaluated during the COVID-19. Neonatal hypoglycemia (RR 4.04; 95% CI 1.37-11.98, p=0.012), and SGA rates (RR 4.29; 95% CI 1.93-9.54, p<0.001) were higher in the group assessed before the pandemic. CONCLUSIONS: Despite economic, social and structural impacts of the pandemic, parameters of maternal care were similar; diabetes control improved, and neonatal hypoglycemia and SGA rates were lower among pregnant women with diabetes during the pandemic.

The impact of a telehealth intervention on the metabolic profile of diabetes mellitus patients during the COVID-19 pandemic - A randomized clinical trial.

OBJECTIVES: The objective of this study was to evaluate the impact of a telehealth intervention on metabolic outcomes and self-perceptions of the patients regarding their management of diabetes during the COVID-19 pandemic. METHODS: This is a non-blind randomized controlled clinical trial to assess a telehealth intervention. We included adults with diabetes mellitus. The outcomes assessed were the level of HbA1c, lipid profile, blood pressure levels, weight, body mass index and self-perceptions about diabetes management. RESULTS: A total of 150 individuals with diabetes participated in the study and at the end of telehealth intervention there were no changes in the patient's HbA1c levels between intervention and control groups for neither type 1 (8.1% vs. 8.6%; p = 0.11) nor type 2 diabetes (8.6% vs. 9.0%; p = 0.09), respectively. From the rest of the metabolic profile, triglyceride levels from type 1 diabetes group was the only variable that demonstrated improvement with telehealth intervention (66.5% intervention group vs. 86.5% control group; p = 0.05). CONCLUSIONS: After 4 months of telehealth intervention, no statistically significant results were observed in HbA1c nor in secondary outcomes (with the exception of triglycerides for the type 1 diabetes group).

Lifestyle pattern changes, eating disorders, and sleep quality in diabetes: how are the effects of 18 months of COVID-19 pandemic being felt?

AIMS: The pandemic resulted in a lifestyle crisis which may negatively affect patients with diabetes. Despite current knowledge, there is a lack of longitudinal studies evaluating this effect. To assess patients' perceptions about changes in lifestyle, and eating and sleeping patterns after 18 months of the COVID-19 pandemic, and to identify if aspects related to the pandemic (social distancing, COVID-19 infection, behavioral changes, and financial difficulties) are predictors of worsening in eating and sleeping parameters. METHODS: This was a longitudinal study that followed patients with diabetes from April 2020 to July 2021 in Southern Brazil. Individuals with type 1 or type 2 diabetes, aged ≥ 18 years, were included. The outcome of this study was the assessment of daily habits during a 18-month period of the COVID-19 pandemic. Specific questionnaires were applied once participants were included in this study (3 months after the onset of the pandemic) and at the 18-month follow-up, which included the Eating Attitudes Test-26 (EAT-26), the Mini-Sleep Questionnaire (MSQ), and a specific questionnaire on diet, physical activity, and sleep pattern. Data were compared within and between groups (type 1 and type 2 diabetes), and multivariable models were used to identify subgroups of worse outcomes. RESULTS: A total of 118 (78.6%) participants remained in the study at follow-up (mean age 54.6 ± 13.9 years, 41.3% male). In total, 33.9% of participants perceived weight gain during the pandemic, especially those with type 1 diabetes (43.1% vs 25.0% in type 2 diabetes, P = 0.04). About one in four participants reported emotional eating and changes in their eating habits for financial reasons. Regarding sleep patterns, more than half the participants reported taking naps during the day, out of which 30.5% of them perceived worse sleep quality, with no difference between type 1 and type 2 diabetes groups. There were no within-group differences in MSQ and EAT-26 scores. Among participants with type 2 diabetes, age ≥ 60 years (OR 27.6, 95%CI 2.2-345.7), diabetes duration ≥ 15 years (OR 28.9, 95%CI 1.4-597.9), and perceived emotional eating (OR 10.9, 95%CI 1.1-107.5) were associated with worsened food quality. Worse sleep quality during the pandemic was associated with age ≥ 60 years for both type 2 diabetes (OR 5.6, 95%CI 1.1-31.5) and type 1 diabetes (OR 5.5, 95%CI 1.0-29.9). CONCLUSIONS: Follow-up data from a cohort of patients with diabetes indicate that at the end of 18 months of social distancing, some lifestyle aspects worsened and some improved, showing that these patients responded differently to the adversities of this period. The evidence of clinical features associated with worsening in food and sleep quality provides new insights to prioritizing actions in crisis situations.

Healthy lifestyle gone bad: effect of the COVID-19 pandemic on the daily habits of children and adolescents with type 1 diabetes.

Objective: To assess caregivers' perception about the changes in the daily habits of children and adolescents with type 1 diabetes during the COVID-19 pandemic. Subjects and methods: Primary caregivers of youth aged ≤18 with or without type 1 diabetes were selected for the diabetes and the control groups. Caregivers estimated the youth's time (hours) of physical activity and screen time before and during the pandemic, and rated the quality of eating habits and medication adherence from 0 to 10. The primary outcome was the change in physical activity time, screen time, and eating habits scores during isolation. Between-group analyses and within-group comparisons were conducted. A post hoc analysis was performed using logistic regression to correct for confounding factors. Results: In total, 764 participants were included (381 diabetes group vs. 383 control group). Before the pandemic, the diabetes group presented a reduced median of physical activity (P < 0.001) and screen time (P < 0.001). During the pandemic, the difference between both groups remained similar (P = 0.58). Scores of quality of eating habits were similar in both groups before the pandemic [8.0 (7.0-9.0) vs. 8.0 (7.0-9.0), P = 0.31] but decreased during the pandemic [7.0 (5.1-8.1) vs. 8.0 (6.0-9.0), P < 0.001]. The diabetes group had a significantly worse change in eating habits scores (P < 0.01). Conclusion: During the pandemic, eating habits were significantly worse in youth with diabetes than in those without diabetes.

Healthy lifestyle gone bad: effect of the COVID-19 pandemic on the daily habits of children and adolescents with type 1 diabetes

ABSTRACT Objective: To assess caregivers' perception about the changes in the daily habits of children and adolescents with type 1 diabetes during the COVID-19 pandemic. Subjects and methods: Primary caregivers of youth aged ≤18 with or without type 1 diabetes were selected for the diabetes and the control groups. Caregivers estimated the youth's time (hours) of physical activity and screen time before and during the pandemic, and rated the quality of eating habits and medication adherence from 0 to 10. The primary outcome was the change in physical activity time, screen time, and eating habits scores during isolation. Between-group analyses and within-group comparisons were conducted. A post hoc analysis was performed using logistic regression to correct for confounding factors. Results: In total, 764 participants were included (381 diabetes group vs. 383 control group). Before the pandemic, the diabetes group presented a reduced median of physical activity (P < 0.001) and screen time (P < 0.001). During the pandemic, the difference between both groups remained similar (P = 0.58). Scores of quality of eating habits were similar in both groups before the pandemic [8.0 (7.0-9.0) vs. 8.0 (7.0-9.0), P = 0.31] but decreased during the pandemic [7.0 (5.1-8.1) vs. 8.0 (6.0-9.0), P < 0.001]. The diabetes group had a significantly worse change in eating habits scores (P < 0.01). Conclusion: During the pandemic, eating habits were significantly worse in youth with diabetes than in those without diabetes.

Type 1 diabetes and the challenges of emotional support in crisis situations: results from a feasibility study of a multidisciplinary teleintervention.

The association between type 1 diabetes and mental health disorders could be exacerbated in a stressful environment. This study aimed to evaluate the feasibility of a teleguided intervention on emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. This study was performed during the social distancing period in the COVID-19 outbreak in Brazil. Individuals with type 1 diabetes aged ≥ 18 years were selected to receive a teleguided multidisciplinary intervention or the usual care plus an educational website access. The proposed intervention aimed addressing aspects of mental health, diabetes care and lifestyle habits during the pandemic. The feasibility outcome included the assessment of recruitment capability and adherence to the proposed intervention. Moreover, we evaluated the presence of positive screening for emotional disorders (Self Report Questionnaire 20) after a 16-week intervention, patients' perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders. Data were analyzed with the intent-to-treat principle. Fifty-eight individuals (mean age, 43.8 ± 13.6 years) were included (intervention group, n = 29; control group, n = 29). At the end of the study, a total of 5 participants withdrew from the study in the intervention group compared to only 1 in the control group. Participants who dropout from the study had similar mean age, sex and income to those who remained in the study. The analysis of mental health disorders was not different between the groups at the follow up: a positive screening result was found in 48.3% and 34.5% of participants in the intervention and control groups, respectively (P = 0.29). The intervention group felt more supported in their diabetes care during the social distancing period (82.8% vs. 48.3% in the control group, P < 0.01). Our study identified a disproportionate higher number of withdrawals in the intervention group when compared to the control group. This difference may have compromised the power of the study for the proposed assessments and should be reevaluated in future studies.Trial registration: ClinicalTrials.gov (NCT04344210). Date of registration: 14/04/2020.

Quality of care in patients with type 1 diabetes during the COVID-19 pandemic: a cohort study from Southern Brazil.

BACKGROUND: Optimal glycemic control is the main goal for patients with diabetes. The results of type 1 diabetes patients' neglected demands during the pandemic can determine a long-term negative clinical, social, and economic impact, and result in worse diabetes control and a higher incidence of chronic complications. Therefore, this study aims to evaluate the impact of the COVID-19 outbreak in the quality of care of patients with type 1 diabetes in Southern Brazil. METHODS: Cohort study based on electronic medical records of patients with type 1 diabetes, with scheduled appointments between January 1st 2020, and November 6th 2020, at a university public hospital. The quality indicators used were: assessment of albuminuria and/or serum creatinine, lipid profile, thyroid-stimulating hormone, glycated hemoglobin, retinopathy, and neuropathy. McNemar test was used to analyze categorical variables and the Wilcoxon test for continuous variables. RESULTS: Out of 289 patients, 49.5% were women aged 40 ± 12 years old. During the pandemic, 252 patients had at least one face-to-face appointment canceled. The quality of care indicators showed a significant worsening during the COVID-19 pandemic compared to the previous year (p < 0.001). In 2019, 23.2% of the participants had all the indicators evaluated, while in 2020, during the pandemic, only 3.5% had all of them evaluated. CONCLUSION: The COVID-19 pandemic hindered the offer of comprehensive and quality care to patients with type 1 diabetes.

Type 1 diabetes and the challenges of emotional support in crisis situations: results from a randomized clinical trial of a multidisciplinary teleintervention.

The association between type 1 diabetes and mental health disorders could be exacerbated in a stressful environment. This study aimed to evaluate the effectiveness of a teleguided intervention on emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. An open-label clinical trial was performed during the social distancing period in the COVID-19 outbreak in Brazil. Individuals with type 1 diabetes aged ≥ 18 years were randomized to receive a teleguided multidisciplinary intervention or the usual care plus an educational website access. The primary outcome was a positive screening for emotional disorders (Self Report Questionnaire 20) after a 16-week intervention. Secondary outcomes included evaluation of patients' perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders. Data were analyzed with the intent-to-treat principle. Fifty-eight individuals (mean age, 43.8 ± 13.6 years) were included (intervention group, n = 29; control group, n = 29). The primary outcome was not different between the groups. The intervention group felt more supported in their diabetes care during the social distancing period (82.8% vs. 48.3% in the control group, P < 0.01). Both groups reported a similar self-perceived worsening of physical activity habits and mental health during the outbreak. There was no benefit to using the telehealth strategy proposed for emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. Further studies are needed to determine the impact on metabolic parameters and to understand why it is so difficult to emotionally support these patients.Trail Registration: ClinicalTrials.gov (NCT04344210), 14/04/2020.

Polysomnography in pre-operative screening for obstructive sleep apnea in patients undergoing bariatric surgery: a retrospective cohort study.

BACKGROUND/OBJECTIVES: To assess the impact of obstructive sleep apnea (OSA) screening with polysomnography on preventing cardiovascular and pulmonary complications in the postoperative period of bariatric surgery. SUBJECTS/METHODS: This was a single-center retrospective cohort study, including 522 adults who underwent bariatric surgery between August 2010 and May 2019. Electronic medical records were accessed to obtain variables of interest. Screening for OSA was performed as a medical indication and registered as positive if apnea-hypopnea index was ≥5 events/hour in patients who did not have previous OSA diagnosis. The primary outcome was the presence of cardiac or pulmonary events in the 30-day postoperative period. Secondary outcomes included length of stay (days), need for an intensive care unit (ICU) after surgery, length of mechanical ventilation, and time from mechanical ventilation withdrawal. Statistical analyses were performed with χ2, Fisher's exact test, Student's t-test, Mann-Whitney U test, and Poisson regression. RESULTS: Most participants (n = 326) did not have OSA screening with polysomnography, while 196 had performed this screening. There was no difference in cardiopulmonary events between the screening and non-screening groups (4.2% vs. 2.8%; P = 0.45). Polysomnography screening could not reduce cardiovascular or pulmonary complications in the postoperative period, RR = 1.73 (95% CI: 0.68-4.14). There was no difference in ICU admission, length of stay, and time from mechanical ventilation between groups in secondary outcomes. CONCLUSIONS: Our study suggests that OSA screening with polysomnography in the pre-operative care of bariatric surgery is a dispensable procedure, as it does not change postoperative cardiopulmonary outcomes. Indications for polysomnography should be made at the individual level.

Medical adherence in the time of social distancing: a brief report on the impact of the COVID-19 pandemic on adherence to treatment in patients with diabetes

ABSTRACT We conducted a cross-sectional study to evaluate the impact of social distancing determined by the COVID-19 pandemic on treatment adherence using the Self-Care Inventory-revised in adults with diabetes mellitus. In type 1 diabetes, the adherence score was lower during than before social distancing.

"Not having a minute of self-distancing during the social distancing is exhausting": a qualitative study on the perspective of caregivers of youth with type 1 diabetes during the COVID-19 pandemic.

OBJECTIVE: To investigate the impact of the COVID-19 pandemic on caregivers of youth with type 1 diabetes. METHODS: We performed a qualitative research based on an open-ended questionnaire that was conducted through an online platform for primary caregivers of children and adolescents with type 1 diabetes. Participants were asked to describe the impact of the COVID-19 outbreak on their caring for youth with diabetes, as well as the emotional burden that it has brought to their personal lives. Interview responses were coded and stratified by youth age: ≤ 12 years (youth aged ≤ 12 years) and between 13 and 18 years (youth aged > 12 years). The connections between the responses were identified based on either positive or negative content of the reported experience. Data were analyzed in accordance with an inductive reasoning methodology. RESULTS: A total of 318 participants (mean age of 40.3 ± 8.1 years old) were included, representing caregivers of youth aged 11.7 ± 4.3-year-old with diabetes duration of 5.1 ± 3.8 years. The preponderance of negative feelings was noteworthy. Regarding diabetes care, more than 80% of participants reported concern and anxiety about the changes in habits that accompanied the pandemic. Also, more than half of caregivers regretted the isolation of their youth, factors that were associated with greater difficulty in achieving good glycemic control. Regarding the personal burden experienced, the negative impact of uncertainties and concerns about the COVID-19 were present in almost all participants. CONCLUSION: The period of pandemic may lead to exhaustion in caregivers of youths with type 1 diabetes, which reflects the need for mental health support strategies to help those families.