Clinical trial
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
Name
C-549
Description
Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Trial arms
Trial start
2022-09-01
Estimated PCD
2022-12-01
Trial end
2022-12-31
Status
Completed
Treatment
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.
Arms:
Vaccination adherence
Influenza vaccination
Correct influenza vaccination status was considered in the following situation:
- Received at least one Influenza vaccine dose in the last year.
Arms:
Vaccination adherence
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.
Arms:
Vaccination adherence
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.
Arms:
Vaccination adherence
Size
300
Primary endpoint
Vaccination adherence
1 year and a half
Eligibility criteria
Inclusion Criteria:
* Type 1 diabetes
* Age: 18 yrs. or older
Exclusion Criteria:
* Other diabetes types.
* Younger than 18 years.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}
Updated at
2023-02-08
1 organization
4 products
1 indication
Organization
Castilla-La Mancha Health ServiceProduct
Covid-19 vaccinationIndication
Type 1 DiabetesProduct
Influenza vaccinationProduct
Pneumococcal vaccination