NCT05481801

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Covid-19 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.
BIOLOGICAL	Influenza vaccination	Correct influenza vaccination status was considered in the following situation: \- Received at least one Influenza vaccine dose in the last year.
BIOLOGICAL	Pneumococal vaccination	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.
BIOLOGICAL	Hepatitis B Virus (HBV) vaccination	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-12-01
• Completion: 2022-12-31
• First posted: 2022-08-01
• Last updated: 2023-02-08

Locations

1 site across 1 country: Spain