Attrition and social vulnerability during 2-year-long structured care in type 2 diabetes, the ERMIES randomized controlled trial.

BACKGROUND: Diabetes self-management education is exposed to attrition from services and structured ambulatory care. However, knowledge about factors related to attrition in educational programs remains limited. The context of social vulnerability due to low income may interfere. The aim of this study was to identify the sociodemographic, clinical, psychometric, and lifestyle factors associated with attrition from the ERMIES multicentre randomized parallel controlled trial (RCT) that was interrupted due to the combination of both slow inclusion and high attrition. METHODS: The ERMIES trial was performed from 2011 to 2016 on Reunion Island, which is characterized by a multicultural population and high social vulnerability. The original objective of the RCT was to test the efficacy of a2-year structured group self-management education in improving blood glucose in adult patients with nonrecent, insufficiently controlled type 2 diabetes. One hundred participants were randomized to intensive educational intervention maintained over two years (n = 51) versus only initial education (n = 49). Randomization was stratified on two factors: centres (five strata) and antidiabetic treatment (two strata: insulin-treated or not). Sociodemographic, clinical, health-care access and pathway, psychometric and lifestyle characteristics data were collected at baseline and used to assess determinants of attrition in a particular social context and vulnerability. Attrition and retention rates were measured at each visit during the study. Multiple correspondence analysis and Cox regression were performed to identify variables associated with attrition. RESULTS: The global attrition rate was 26% during the study, with no significant difference between the two arms of randomization (9 dropouts out of 51 patients in the intervention group and 17 out of 49 in the control group). Male gender, multiperson household, low household incomes (< 800 euros), probable depression and history of hospitalization or medical leave at inclusion were associated with a higher risk of attrition from the study in multivariate regression. CONCLUSIONS: Social context, vulnerability, and health care history were related to attrition in this 2-year longitudinal comparative study of structured care. Considering these potential determinants and biases is of importance in scaling up interventions aimed at the optimization of long-term care in type 2 diabetes mellitus. TRIAL REGISTRATION: ID_RCB number: 2011-A00046-35, Clinicaltrials.gov number: NCT01425866 (Registration date: 30/08/2011). SOURCE OF FUNDING: Ministry of Health, France.

Sex disparities in COVID-19 outcomes of inpatients with diabetes: insights from the CORONADO study.

OBJECTIVE: Male sex is one of the determinants of severe coronavirus diseas-e-2019 (COVID-19). We aimed to characterize sex differences in severe outcomes in adults with diabetes hospitalized for COVID-19. METHODS: We performed a sex-stratified analysis of clinical and biological features and outcomes (i.e. invasive mechanical ventilation (IMV), death, intensive care unit (ICU) admission and home discharge at day 7 (D7) or day 28 (D28)) in 2380 patients with diabetes hospitalized for COVID-19 and included in the nationwide CORONADO observational study (NCT04324736). RESULTS: The study population was predominantly male (63.5%). After multiple adjustments, female sex was negatively associated with the primary outcome (IMV and/or death, OR: 0.66 (0.49-0.88)), death (OR: 0.49 (0.30-0.79)) and ICU admission (OR: 0.57 (0.43-0.77)) at D7 but only with ICU admission (OR: 0.58 (0.43-0.77)) at D28. Older age and a history of microvascular complications were predictors of death at D28 in both sexes, while chronic obstructive pulmonary disease (COPD) was predictive of death in women only. At admission, C-reactive protein (CRP), aspartate amino transferase (AST) and estimated glomerular filtration rate (eGFR), according to the CKD-EPI formula predicted death in both sexes. Lymphocytopenia was an independent predictor of death in women only, while thrombocytopenia and elevated plasma glucose concentration were predictors of death in men only. CONCLUSIONS: In patients with diabetes admitted for COVID-19, female sex was associated with lower incidence of early severe outcomes, but did not influence the overall in-hospital mortality, suggesting that diabetes mitigates the female protection from COVID-19 severity. Sex-associated biological determinants may be useful to optimize COVID-19 prevention and management in women and men.

Predictors of hospital discharge and mortality in patients with diabetes and COVID-19: updated results from the nationwide CORONADO study.

AIMS/HYPOTHESIS: This is an update of the results from the previous report of the CORONADO (Coronavirus SARS-CoV-2 and Diabetes Outcomes) study, which aims to describe the outcomes and prognostic factors in patients with diabetes hospitalised for coronavirus disease-2019 (COVID-19). METHODS: The CORONADO initiative is a French nationwide multicentre study of patients with diabetes hospitalised for COVID-19 with a 28-day follow-up. The patients were screened after hospital admission from 10 March to 10 April 2020. We mainly focused on hospital discharge and death within 28 days. RESULTS: We included 2796 participants: 63.7% men, mean age 69.7 ± 13.2 years, median BMI (25th-75th percentile) 28.4 (25.0-32.4) kg/m2. Microvascular and macrovascular diabetic complications were found in 44.2% and 38.6% of participants, respectively. Within 28 days, 1404 (50.2%; 95% CI 48.3%, 52.1%) were discharged from hospital with a median duration of hospital stay of 9 (5-14) days, while 577 participants died (20.6%; 95% CI 19.2%, 22.2%). In multivariable models, younger age, routine metformin therapy and longer symptom duration on admission were positively associated with discharge. History of microvascular complications, anticoagulant routine therapy, dyspnoea on admission, and higher aspartate aminotransferase, white cell count and C-reactive protein levels were associated with a reduced chance of discharge. Factors associated with death within 28 days mirrored those associated with discharge, and also included routine treatment by insulin and statin as deleterious factors. CONCLUSIONS/INTERPRETATION: In patients with diabetes hospitalised for COVID-19, we established prognostic factors for hospital discharge and death that could help clinicians in this pandemic period. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04324736.