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

Type 1 Diabetes Mellitus Clinical Trial

— AVADI-1  

Official title:

Adherence to Guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in Adult Patients With Type 1 Diabetes Mellitus (AVADI-1).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478254
• Other study ID #: C-127
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2020
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Spain	Obispo Rafael Torija, St.	Ciudad Real

Sponsors (3)

Lead Sponsor	Collaborator
Jesús Moreno Fernández	Castilla-La Mancha Health Service, University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Alcusky MJ, Pawasauskas J. Adherence to Guidelines for Hepatitis B, Pneumococcal, and Influenza Vaccination in Patients With Diabetes. Clin Diabetes. 2015 Jul;33(3):116-22. doi: 10.2337/diaclin.33.3.116. — View Citation

American Association of Diabetes Educators. Vaccination practices for hepatitis B, influenza, and pneumococcal disease for people with diabetes. Diabetes Educ. 2014 Jan-Feb;40(1):122-4. doi: 10.1177/0145721713513545. — View Citation

Muller LM, Gorter KJ, Hak E, Goudzwaard WL, Schellevis FG, Hoepelman AI, Rutten GE. Increased risk of common infections in patients with type 1 and type 2 diabetes mellitus. Clin Infect Dis. 2005 Aug 1;41(3):281-8. Epub 2005 Jun 16. — View Citation

Sastre J, Pinés PJ, Moreno J, Aguirre M, Blanco B, Calderón D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish. — View Citation

Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care. 2003 Feb;26(2):510-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Age According to Vaccination Status	Age (years)	1 year
Secondary	Number of Participants Who Have Taken Related Sick Leaves	Number of patients who have taken related sick leaves.	1 year