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

Study Overview
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Brief Summary
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Observational study about adherence to guidelines for 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 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 for Influenza, Pneumococcal and Hepatitis B Vaccination in Adult Patients With Type 1 Diabetes Mellitus (AVADI-1).

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Biological: Influenza vaccination
* Biological: Pneumococcal vaccination
* Biological: Hepatitis B Virus (HBV) vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age. Diagnosed of Type 1 Diabetes Mellitus. Be attended in Ciudad Real General University Hospital. Exclusion Criteria: Less than 18 years old. Other types of diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status. | 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: Pneumococcal 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 |
| --- | --- | --- |
| Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM | Adherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Age According to Vaccination Status | Age (years) | 1 year | 
| Number of Participants Who Have Taken Related Sick Leaves | Number of patients who have taken related sick leaves. | 1 year |