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).

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.

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.

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.

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.

Telehealth strategy to mitigate the negative psychological impact of the COVID-19 pandemic on type 2 diabetes: A randomized controlled trial.

AIMS: To assess the impact of teleintervention on mental health parameters in type 2 diabetes patients during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: This is a controlled randomized trial for a multidisciplinary telehealth intervention in Southern Brazil, with social distancing measures. Adults aged 18 years or older with previous diagnosis of type 2 diabetes were included in the study. The intervention performed was a set of strategies to help patients stay healthy during the COVID-19 pandemic and included the maintaining of telephone contacts and providing educational materials on issues related to mental health, healthy habits, and diabetes care. The primary outcome was a positive screening for mental health disorders (Self-Reporting Questionnaire) after 16 weeks of intervention. A positive screening for mental health disorders was considered when the survey scored greater than or equal to 7. Secondary outcomes included a positive screening for diabetes-related emotional distress (Problem Areas in Diabetes), eating (Eating Attitudes Test), and sleep disorders (Mini Sleep Questionnaire). Comparisons with χ2 tests for dichotomous outcomes, along with the Mann-Whitney U test, was used for between group analyses. RESULTS: A total of 91 individuals agreed to participate (46 intervention group and 45 control group). There were no differences in demographic and clinical data at baseline. After 16 weeks of follow-up, a positive screening for mental health disorders was found in 37.0% of participants in the intervention group vs. 57.8% in the control group (P = 0.04). Diabetes-related emotional distress was found in 21.7% of participants in the intervention group vs. 42.2% in the control group (P = 0.03). No differences were found between groups with regard to eating and sleep disorders. CONCLUSION: This study demonstrated that maintaining remote connections with health professionals during social distancing and quarantine have the potential to reduce the prevalence of positive screening for mental health disorders and diabetes-related emotional distress in adults with type 2 diabetes.

Mental health in the era of COVID-19: prevalence of psychiatric disorders in a cohort of patients with type 1 and type 2 diabetes during the social distancing.

BACKGROUND: In patients with diabetes, the prevalence of depression and anxiety symptoms is about two to four times greater than in the general population. The association between diabetes and mental health disorders could be exacerbated in a stressful environment, and psychological distress could increase depressive symptoms and cause adverse diabetes outcomes. OBJECTIVES: To assess the prevalence of mental health disorders in patients with diabetes during the social distancing period due to COVID-19 pandemic. METHODS: This is a cross-sectional study developed to assess the impact of social distancing on a cohort of adults with type 1 (n = 52) and type 2 diabetes (n = 68) in Brazil. Inclusion criteria involved having an HbA1c test collected in the past 3 months and having a valid telephone number in electronic medical records. The primary outcome was the prevalence of minor psychiatric disorders, assessed by survey (SRQ-20). Secondary outcomes included the prevalence of diabetes related emotional distress, eating and sleeping disorders, all assessed by validated surveys at the moment of the study. Statistical analyses included unpaired t-test for continuous variables and χ 2 test for categorical variables. RESULTS: Overall (n = 120), participants had a mean age of 54.8 ± 14.4 years-old, and HbA1c of 9.0 ± 1.6% (75 ± 17.5 mmol/mol); 93% of patients showed signs of current mental suffering based on the surveys measured. Almost 43% of patients showed evidence of significant psychological distress, with a significant greater tendency in patients with type 2 diabetes. The presence of diabetes related emotional distress was found in 29.2% of patients; eating disorders in 75.8%; and moderate/severe sleeping disorders in 77.5%. CONCLUSIONS: We found a high prevalence of evidence of psychological distress among patients with diabetes during the COVID-19 pandemic and this highlights the need for mental health access and support for patients with type 1 and type 2 diabetes.