Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05481801
Acronym
AVADI-2
Enrollment
300
Registered
2022-08-01
Start date
2022-09-01
Completion date
2022-12-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief 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.

Interventions

BIOLOGICALCovid-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.

BIOLOGICALInfluenza vaccination

Correct influenza vaccination status was considered in the following situation: \- Received at least one Influenza vaccine dose in the last year.

BIOLOGICALPneumococal 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.

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.

Sponsors

Castilla-La Mancha Health Service
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Other diabetes types. * Younger than 18 years.

Design outcomes

Primary

MeasureTime frameDescription
Vaccination adherence1 year and a halfAdherence 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

MeasureTime frameDescription
Sick Leaves1 year and a halfTotal number of related sick leaves due to Covid-19, pneumococcus, influenzae or HBV according to vaccination status (vaccinated or not vaccinated).
Hospital admission1 year and a halfNumber of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.
Death1 year and a halfMortality rate according to vaccination status

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026