Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)

Study Overview
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Brief Summary
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Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

Detailed Description
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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.

Official Title
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Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Biological: Covid-19 vaccination
* Biological: Influenza vaccination
* Biological: Pneumococal vaccination
* Biological: Hepatitis B Virus (HBV) vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes Age: 18 yrs. or older Exclusion Criteria: Other diabetes types. Younger than 18 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccination adherence<br>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<br>* 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.<br>Biological: Influenza vaccination<br>* Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year.<br>Biological: Pneumococal vaccination<br>* 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.<br>Biological: Hepatitis B Virus (HBV) vaccination<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year and a half | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick Leaves | Total number of related sick leaves due to Covid-19, pneumococcus, influenzae or HBV according to vaccination status (vaccinated or not vaccinated). | 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. | 1 year and a half | 
| Death | Mortality rate according to vaccination status | 1 year and a half |