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Completed

NCT Number: NCT05481801

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes
  • Age: 18 yrs. or older

Exclusion criteria

  • Other diabetes types.
  • Younger than 18 years.

Treatment and study plan

COVID-19 Vaccination

Biological

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.

Influenza vaccination

Biological

Correct influenza vaccination status was considered in the following situation:

  • Received at least one Influenza vaccine dose in the last year.

Pneumococal vaccination

Biological

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.

Hepatitis B Virus (HBV) vaccination

Biological

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.

Primary outcomes

  1. Vaccination adherence

    Time frame: 1 year and a half

    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

Secondary outcomes

  1. Sick Leaves

    Time frame: 1 year and a half

    Total number of related sick leaves due to Covid-19, pneumococcus, influenzae or HBV according to vaccination status (vaccinated or not vaccinated).

  2. Hospital admission

    Time frame: 1 year and a half

    Number of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.

  3. Death

    Time frame: 1 year and a half

    Mortality rate according to vaccination status

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Registry information

Acronym: AVADI-2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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