662864fc34d57fca8c1bb6b215effeb5 305891.pdf 5f1f3396c444b59f55e6e27cdb0dea9bc37a8680 305891.pdf f3240734451fb7d9e511d17bb27e2902eec0f3bb468e87f5b013e193071a697a 305891.pdf Title: Metabolic and Clinical Outcomes in Type 1 Diabetes in the COVID-19 Pre- and Post-Vaccination Periods in Spain:The COVID-SED1 Study Subject: Aims: To evaluate the metabolic and clinical outcomes in the Spanish type 1 diabetes mellitus (T1D) population before and after COVID-19 vaccination. Methods: A retrospective observational study was carried out in Spanish public hospitals previously enrolled in the SED1 study. Adults and children with T1D were included and their clinical electronic records were reviewed. Clinical, laboratory, and glucometric parameters from continuous glucose monitoring (CGM) data corresponding to the periods before and after administering the first COVID-19 vaccination were analyzed. Results: A total of 26 centers and 228 patients participated in this new phase of the SED1 study and 187 were finally evaluable (mean age 37.5 15.6 years, 56.7% women). Overall, 94.6% of the sample was vaccinated, and this percentage increased with higher levels of education (p-value = 0.027). In the pre- and post-vaccination periods, respectively, the number of patients with acute hyperglycemic decompensation was 6/161 (3.7%) and 7/161 (4.3%) (p = 1) and with acute hypoglycemic decompensation was 6/161 (3.7%) and 6/161 (3.7%) (p = 1). The HbA1c level was lower in the post-vaccination period(mean SD, mg/dL): pre-vaccination 7.4 0.9; post-vaccination 7.2 1.0, (-0.19; p-value = 0.0006). A total of 31.9% of patients (95% CI: 24.7–39.7) in the pre-vaccination period and 45.0% (IC95%: 37.1–53.1) in the post-vaccine period had HbA1c < 7% (p-value < 0.001). Glucometrics from CGM data also showed numerical improvements post-vaccination. Conclusions: The COVID-19 vaccination was highly accepted in the Spanish T1D population, with hesitancy about the COVID-19 vaccine being higher in those with lower educational levels. A mildly better glycemic control was observed in the post-vaccination period. Keywords: type 1 diabetes; COVID-19; vaccination; glycemic control; continuous glucose monitoring; diabetes complications Author: Fernando Gómez-Peralta, Edelmiro Menéndez, Santiago Conde, Pablo Abellán-Galiana, Miguel Brito, Marina Beléndez and Antonio Pérez Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Wed Mar 27 10:13:57 2024 CET ModDate: Wed Mar 27 10:29:37 2024 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 12 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 264200 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- ZZTQUO+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 NQTYUW+URWPalladioL-Bold Type 1 Custom yes yes yes 16 0 YDCOEL+URWPalladioL-Roma Type 1 Custom yes yes yes 22 0 WJCUCD+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 GQWIGS+CMSY10 Type 1 Builtin yes yes yes 32 0 YLNWFX+VnURWPalladioL Type 1 Custom yes yes yes 37 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 53 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 56 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 85 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-02-11 02:50:36 CET RepresentationInformation: 305891.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-02-10 13:44:37 CET Size: 264200 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 232 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Study Design Destination: subsection.2.1 Item: Title: Endpoints Destination: subsection.2.2 Item: Title: Evaluated Variables Destination: subsection.2.3 Item: Title: Statistical Analysis Destination: subsection.2.4 Item: Title: Results Destination: section.3 Children: Item: Title: Population Destination: subsection.3.1 Item: Title: COVID-19 Vaccination Destination: subsection.3.2 Item: Title: COVID-19-Related Events Destination: subsection.3.3 Item: Title: Comorbidity and Complications Associated with T1D Destination: subsection.3.4 Item: Title: HbA1c before and after Vaccination Destination: subsection.3.5 Item: Title: Glucometrics and CGM-Derived Variables before and after Vaccination Destination: subsection.3.6 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: Appendix A Destination: appendix.A. Item: Title: References Destination: appendix.B. Info: Title: Metabolic and Clinical Outcomes in Type 1 Diabetes in the COVID-19 Pre- and Post-Vaccination Periods in Spain:The COVID-SED1 Study Author: Fernando Gómez-Peralta, Edelmiro Menéndez, Santiago Conde, Pablo Abellán-Galiana, Miguel Brito, Marina Beléndez and Antonio Pérez Subject: Aims: To evaluate the metabolic and clinical outcomes in the Spanish type 1 diabetes mellitus (T1D) population before and after COVID-19 vaccination. Methods: A retrospective observational study was carried out in Spanish public hospitals previously enrolled in the SED1 study. Adults and children with T1D were included and their clinical electronic records were reviewed. Clinical, laboratory, and glucometric parameters from continuous glucose monitoring (CGM) data corresponding to the periods before and after administering the first COVID-19 vaccination were analyzed. Results: A total of 26 centers and 228 patients participated in this new phase of the SED1 study and 187 were finally evaluable (mean age 37.5 15.6 years, 56.7% women). Overall, 94.6% of the sample was vaccinated, and this percentage increased with higher levels of education (p-value = 0.027). In the pre- and post-vaccination periods, respectively, the number of patients with acute hyperglycemic decompensation was 6/161 (3.7%) and 7/161 (4.3%) (p = 1) and with acute hypoglycemic decompensation was 6/161 (3.7%) and 6/161 (3.7%) (p = 1). The HbA1c level was lower in the post-vaccination period(mean SD, mg/dL): pre-vaccination 7.4 0.9; post-vaccination 7.2 1.0, (-0.19; p-value = 0.0006). A total of 31.9% of patients (95% CI: 24.7 39.7) in the pre-vaccination period and 45.0% (IC95%: 37.1 53.1) in the post-vaccine period had HbA1c < 7% (p-value < 0.001). Glucometrics from CGM data also showed numerical improvements post-vaccination. Conclusions: The COVID-19 vaccination was highly accepted in the Spanish T1D population, with hesitancy about the COVID-19 vaccine being higher in those with lower educational levels. A mildly better glycemic control was observed in the post-vaccination period. 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