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Introduction: Post COVID dyspnea is considered one of the most troublesome symptoms, even after the acute phase of COVID-19 disease. Few data are currently available describing features post-COVD dyspnea. Aims and objectives: To phenoype dyspnea in patients with post-COVID syndrome. Method(s): We enrolled 309 patients who suffered from COVID-19 disease. All patients were screened with a complete blood workup, body plethysmography, arterial blood gas analysis and 6 minute walking test (6MWT). Moreover, 80 patients underwent chest Computed Tomography (CT) according to their clinical status. Result(s): Half of the enrolled patients (51.8%) reported residual dyspnea, both at rest and during their daily activities. Among them, 56.7% of patients had also dyspnea as the first symptom at COVID-19 onset (p=0.04). Patients referring dyspnea showed a lower PaO2 (p=0.02) and an increased pre-post test BORG scale difference (p<0.0001), without significant desaturations (>=3%) during the 6MWT. We also found a decreased 6 minute walking distance in these patients (p=0.004), as well as a reduction in diffusing capacity (DLCO, p=0.0005). After performing a multivariate logistic regression, only DLCO resulted to be statistically significant (OR=0.97, p=0.03). Moreover, among our patients who performed chest CT, 76.2% of them were found to have residual abnormalities such as ground glass opacities (50%), lung scars (26.2%) and parenchymal consolidations (12.5%). Conclusion(s): DLCO reduction is the most influencing factor for the development of post-COVID dyspnea. Moreover, PaO2, 6MWT parameters and chest CT alterations can also increase the breathing discomfort in these patients.
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Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective(s): Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Method(s): We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Result(s): We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p<0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p<0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion(s): Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
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Introduction: Rare or serious Adverse Events (AEs) in the reproductive sphere have been reported following the administration of the COVID-19 vaccine, especially mRNA vaccines. Although several fertility Societies have announced that COVID-19 mRNA vaccines are unlikely to affect fertility, pregnancy, or breastfeeding, there is no denying that the current evidence is very limited [1]. Objective(s): Aim of this study was a post-marketing assessment of the safety profile of COVID-19 vaccines, through the analysis of the Individual Case Safety Reports (ICSRs) collected in EudraVigilance in 2021 year, by focusing on reproductive disorders. Method(s): We analyzed all ICSRs that contained at least one COVID- 19 vaccine as suspected and at least one AE belonging to the Standardized MedDRA Query (SMQ) level 1 ''Fertility disorders'' or ''Pregnancy and neonatal conditions''. We performed a descriptive analysis and all AEs have been coded as Preferred Term (PT) according to MedDRA. Finally, we used the Reporting Odds Ratio (ROR) with a 95% of Confidence Interval (95% CI) to investigate disproportional reporting of AEs belonging to the SMQs of interest among the vaccines included in the analysis. Result(s): During the study period, 27,089 ICSR were collected and the total number of AEs was found to be 31,337;of these, 62.8% were referred to Comirnaty-, 20.8% to Spikevax-, 12.7% to Vaxzevria-, and 3.7% to Janssen-. For each of the four COVID-19 vaccines, 96.4% were related to female patients, aged between 18-64 years (88.1%), 71.5% were not serious, 46.0% were not resolved yet and 82.3% were reported by non-healthcare professionals. Regardless of the type of vaccine, the most reported PTs were amenorrhea, irregular menstruation, and delayed menstruation. The ROR showed that the probability to report an AE belonging to the SMQ ''Fertility disorders'' is greater for Comirnaty (ROR: 4.20, 95% CI 4.08-4.32) while no statistically significant difference was observed to the SMQ ''Pregnancy and neonatal conditions''. Conclusion(s): In this study, no potential signs of reproductive system safety were found regarding fertility, pregnancy or breastfeeding. Most of the reported events were related to changes in the menstrual cycle, although these disorders are temporary and normally common in the female population. At the time, the EMA's PRAC concluded that the evidence did not support a causal link between these vaccines and menstrual disorders, however, it decided to further studies collecting data from real life contexts are strongly needed to assess their safety profile in relation to reproductive function.
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Introduction: COVID-19 is a complex disease with several clinical phases of progression, affecting many organs apart from the respiratory tract that has shown a worst prognosis in both patients with type 1 and type 2 diabetes mellitus [1]. Based on these considerations, the vaccination for COVID-19 is a priority for this subpopulation [2]. However, few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. Objective(s): We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). Method(s): ICSRs were retrieved for the period from January 1st, 2021 to December 11th, 2021. An ICSR related to events of impaired glucose metabolism was identified by using selected preferred terms (PTs) from Standardized MedDRA Queries ''Hyperglycaemia/new onset diabetes mellitus'' and ''Hypoglycaemia''. Impaired glucose metabolism events were described and analyzed based on the Diabetologists' classification into nine groups: ''diabetes in pregnancy'', ''acute complications of diabetes'', ''pre-diabetes'', ''type 1 diabetes mellitus'', ''type 2 diabetes mellitus'', ''high glucose levels'', ''diabetes mellitus inadequate control'', ''diabetes melli-tus not specified'', and ''hypoglycaemia''. The reporting odds ratios were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. Result(s): During the study period, 3,917 ICSRs with a COVID-19 vaccine as suspected and at least an event of impaired glucose metabolism were retrieved from the EV, of which 2,027 (51.75%) referred to Pfizer-BioNTech vaccine, 586 (14.96%) to Moderna vaccine, 1,163 (29.70%) to Oxford-AstraZeneca vaccine, and 141 (3.59%) to Janssen vaccine. From 3,917 ICSRs, we observed 4,275 impaired glucose metabolism events (1.09 adverse events per ICSR). Most adverse events were classified as serious (2,694;63.02%), and the most reported events were related to ''high glucose levels'' (2,012;47.06%). The mRNA vaccines were associated with an increased reporting frequency of ''type 1 diabetes mellitus'' (ROR 1.86;95% CI 1.33-2.60), ''type 2 diabetes mellitus'' (ROR 1.58;95% CI 1.03-2.42), ''high glucose levels'' (ROR 1.16;95% CI 1.06-1.27), ''diabetes mellitus inadequate control'' (ROR 1.63;95% CI 1.25-2.11), and ''hypoglycemia'' (ROR 1.62;95% CI 1.41-1.86) compared to viral vector-based vaccines. The highest reporting rate per 100,000 was observed for Oxford-AstraZeneca vaccine (1.87;95% CI 1.77-1.97). Conclusion(s): In conclusion, mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycaemic perturbations. Larger nationwide studies are warranted to verify these findings.
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Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective(s): To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Method(s): After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Result(s): 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition: 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for Guillan- Barre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion(s): GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.
ABSTRACT
Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective: Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Methods: We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Results: We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p < 0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p < 0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion: Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
ABSTRACT
Introduction: Rare or serious Adverse Events (AEs) in the reproductive sphere have been reported following the administration of the COVID-19 vaccine, especially mRNA vaccines. Although several fertility Societies have announced that COVID-19 mRNA vaccines are unlikely to affect fertility, pregnancy, or breastfeeding, there is no denying that the current evidence is very limited [1]. Objective: Aim of this study was a post-marketing assessment of the safety profile of COVID-19 vaccines, through the analysis of the Individual Case Safety Reports (ICSRs) collected in EudraVigilance in 2021 year, by focusing on reproductive disorders. Methods: We analyzed all ICSRs that contained at least one COVID-19 vaccine as suspected and at least one AE belonging to the Standardized MedDRA Query (SMQ) level 1 "Fertility disorders" or "Pregnancy and neonatal conditions". We performed a descriptive analysis and all AEs have been coded as Preferred Term (PT) according to MedDRA. Finally, we used the Reporting Odds Ratio (ROR) with a 95% of Confidence Interval (95% CI) to investigate disproportional reporting of AEs belonging to the SMQs of interest among the vaccines included in the analysis. Results: During the study period, 27,089 ICSR were collected and the total number of AEs was found to be 31,337;of these, 62.8% were referred to Comirnaty®, 20.8% to Spikevax®, 12.7% to Vaxzevria®, and 3.7% to Janssen®. For each of the four COVID-19 vaccines, 96.4% were related to female patients, aged between 18-64 years (88.1%), 71.5% were not serious, 46.0% were not resolved yet and 82.3% were reported by non-healthcare professionals. Regardless of the type of vaccine, the most reported PTs were amenorrhea, irregular menstruation, and delayed menstruation. The ROR showed that the probability to report an AE belonging to the SMQ "Fertility disorders" is greater for Comirnaty® (ROR: 4.20, 95% CI 4.08-4.32) while no statistically significant difference was observed to the SMQ "Pregnancy and neonatal conditions". Conclusion: In this study, no potential signs of reproductive system safety were found regarding fertility, pregnancy or breastfeeding. Most of the reported events were related to changes in the menstrual cycle, although these disorders are temporary and normally common in the female population. At the time, the EMA's PRAC concluded that the evidence did not support a causal link between these vaccines and menstrual disorders, however, it decided to further studies collecting data from real life contexts are strongly needed to assess their safety profile in relation to reproductive function.
ABSTRACT
Introduction: COVID-19 is a complex disease with several clinical phases of progression, affecting many organs apart from the respiratory tract that has shown a worst prognosis in both patients with type 1 and type 2 diabetes mellitus [1]. Based on these considerations, the vaccination for COVID-19 is a priority for this subpopulation [2]. However, few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. Objective: We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). Methods: ICSRs were retrieved for the period from January 1st, 2021 to December 11th, 2021. An ICSR related to events of impaired glucose metabolism was identified by using selected preferred terms (PTs) from Standardized MedDRA Queries "Hyperglycaemia/new onset diabetes mellitus" and "Hypoglycaemia". Impaired glucose metabolism events were described and analyzed based on the Diabetologists' classification into nine groups: "diabetes in pregnancy", "acute complications of diabetes", "pre-diabetes", "type 1 diabetes mellitus", "type 2 diabetes mellitus", "high glucose levels", "diabetes mellitus inadequate control", "diabetes melli-tus not specified", and "hypoglycaemia". The reporting odds ratios were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. Results: During the study period, 3,917 ICSRs with a COVID-19 vaccine as suspected and at least an event of impaired glucose metabolism were retrieved from the EV, of which 2,027 (51.75%) referred to Pfizer-BioNTech vaccine, 586 (14.96%) to Moderna vaccine, 1,163 (29.70%) to Oxford-AstraZeneca vaccine, and 141 (3.59%) to Janssen vaccine. From 3,917 ICSRs, we observed 4,275 impaired glucose metabolism events (1.09 adverse events per ICSR). Most adverse events were classified as serious (2,694;63.02%), and the most reported events were related to "high glucose levels" (2,012;47.06%). The mRNA vaccines were associated with an increased reporting frequency of "type 1 diabetes mellitus" (ROR 1.86;95% CI 1.33-2.60), "type 2 diabetes mellitus" (ROR 1.58;95% CI 1.03-2.42), "high glucose levels" (ROR 1.16;95% CI 1.06-1.27), "diabetes mellitus inadequate control" (ROR 1.63;95% CI 1.25-2.11), and "hypoglycemia" (ROR 1.62;95% CI 1.41-1.86) compared to viral vector-based vaccines. The highest reporting rate per 100,000 was observed for Oxford-AstraZeneca vaccine (1.87;95% CI 1.77-1.97). Conclusion: In conclusion, mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycaemic perturbations. Larger nationwide studies are warranted to verify these findings.
ABSTRACT
Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective: To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Methods: After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Results: 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition: 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for GuillanBarre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion: GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.
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Introduction: The Istituto Superiore di Sanita and the Agenzia Italiana del Farmaco coordinate the project TheShinISS-Vax, Flu, a post-marketing "active" surveillance of influenza vaccines. We report the results of the investigation using the Self- Controlled Case Series (SCCS) design on influenza vaccine and Guillain-Barre syndrome in vaccinated population aged over than 6 months, during the influenza vaccine campaign 2020-2021 in Italy. Materials and methods: A SCCS multi-regional study was carried out using linked data from Regional Health Care Registries of Valle d'Aosta, Friuli Venezia Giulia, Emilia-Romagna, Toscana, Lazio, Campania, and Puglia. Relative incidence of Guillain-Barre syndrome was estimated, comparing the exposure risk periods (0-41 days from the vaccination day, subdivided in six intervals) with the unexposed period.
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In 2020 and 2021 the COVID-19 pandemic reshaped the way we work. To help contain the virus employees made a mass migration from working in offices to working remotely from home, but this mass shift to working from home is expected to have a lasting impact on workplace design. Post-pandemic workplaces are expected to be increasingly ‘hybrid’ and use shared workspaces to permit worker fluidity between the office and the home. This article argues that shared and fluid working arrangements significantly disadvantage employees with ‘invisible’ disability in various ways, yet the outdated design of Australian labour law and anti-discrimination law is ill-equipped to deal with these new and emerging inequalities in the workplace. This article proposes law reform and policy solutions designed to enhance ‘person-environment fit’ in workplaces, which may help prevent these inequalities from arising in the post-pandemic world of work. © 2022, University of New South Wales Law Journal. All rights reserved.
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PURPOSE: This study is aimed at evaluating changes in metrics of glucose control in home-isolated patients with type 1 diabetes and COVID-19 using a continuous glucose monitoring (CGM) system. METHODS: We included adults aged 18-45 years with type 1 diabetes, using CGM, followed by telemedicine at a Southern Italian University Hospital. Thirty-two home-quarantined subjects with SARS-CoV-2 positive swab constituted the COVID-19 group. Thirty age-matched diabetic individuals without COVID-19 formed the control group. The effects of COVID-19 on glycemic control in patients infected were assessed at different time points [2 weeks before-COVID-19 (Time 1), 2 weeks during-COVID-19 (Time 2) and 2 weeks after COVID-19 (Time 3)] and compared with those without infection. RESULTS: A significant reduction of TIR (Time 1 vs Time 2, %, 60.1 ± 16.6 vs 55.4 ± 19.2, P = 0.03), associated with a significant increase of TAR level 2 (10.1 ± 7.3 vs 16.7 ± 12.9, P < 0.001), GMI (7.1 ± 0.6 vs 7.5 ± 0.8, P < 0.001), CV (37.3 ± 7.1 vs 39.6 ± 7.0, P = 0.04), mean glucose values (mg/dL, 160.2 ± 26.5 vs 175.5 ± 32.6, P = 0.001) and standard deviation (59.2 ± 13.1 vs 68.6 ± 17.7, P = 0.001) was observed in patients with COVID-19. No significant change of glycemic metrics was found in the NO COVID-19 group across the time. CONCLUSION: Young home-isolated patients with type 1 diabetes and COVID-19 showed a worsening of glucose control during COVID-19, as compared with age-matched diabetic subjects without the infection.