An observational study in Type 1 Diabetes, sponsored by Castilla-La Mancha Health Service. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Castilla-La Mancha Health Service · Observational
Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Cross-sectional analysis about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
All clinical variables are gathered from two EMR softwares (Mambrino XXI and Turriano).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 300 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Castilla-La Mancha Health Service is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All type 1 diabetes patients attendet at the Ciudad Real General University Hospital.
Exclusion Criteria:
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Covid-19, Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status.
Biological: Covid-19 vaccination · Biological: Influenza vaccination · Biological: Pneumococal vaccination · Biological: Hepatitis B Virus (HBV) vaccination
Correct Covid19 vaccination status was considered in the following situation: Received at least two Covid-19 vaccine doses being the last in the last 6 months.
Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year.
Correct pneumococal vaccination status was considered if a subject received at least one of the following options: One pneumococcal conjugate vaccine (PCV) 13 dose in the last year. One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months. One PPSV 23 dose in the last 5 years. One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
Correct Hepatitis B Virus (HBV) vaccination status was considered in the following situation: .- Received at least three consecutive doses of HBV vaccine during six consecutive months.
Vaccination adherence
Adherence ratio (number of vaccinated patients/total number of patients) to regional guidelines for the Immunization for Covid-19, pneumococcus, influenza and HBV of Adults With Type 1 Diabetes Mellitus
Time frame: 1 year and a half
Sick Leaves
Total number of related sick leaves due to Covid-19, pneumococcus, influenzae or HBV according to vaccination status (vaccinated or not vaccinated).
Time frame: 1 year and a half
Hospital admission
Number of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.
Time frame: 1 year and a half
Death
Mortality rate according to vaccination status
Time frame: 1 year and a half
Plan to share: No — Clinical IPD will be available at request from others researchers.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Castilla-La Mancha Health Service