Type 1 Diabetes Mellitus
Conditions
Brief summary
Observational study about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Detailed 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.
Interventions
BIOLOGICALInfluenza vaccination
Correct influenza vaccination status was considered in the following situation: \- Received at least one Influenza vaccine dose in the last year.
BIOLOGICALPneumococcal 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.
BIOLOGICALHepatitis 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.
Sponsors
Castilla-La Mancha Health Service
University of Castilla-La Mancha
Jesús Moreno Fernández
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM | 1 year | Adherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Age According to Vaccination Status | 1 year | Age (years) |
| Number of Participants Who Have Taken Related Sick Leaves | 1 year | Number of patients who have taken related sick leaves. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adherence Vaccination All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, pneumococcal and HBV vaccination status.
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.
HBV vaccination: Correct HBV vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months. | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | Adherence Vaccination |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 280 Participants |
| Age, Continuous | 40 Years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 300 Participants |
| Region of Enrollment Spain | 300 Participants |
| Sex: Female, Male Female | 160 Participants |
| Sex: Female, Male Male | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adherece Vaccination | Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM | No vaccination | 30 Participants |
| Adherece Vaccination | Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM | influenza vaccination | 165 Participants |
| Adherece Vaccination | Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM | Pneumoccocal vaccination | 54 Participants |
| Adherece Vaccination | Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM | HBV vaccination | 51 Participants |
Secondary
Number of Participants Who Have Taken Related Sick Leaves
Number of patients who have taken related sick leaves.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adherece Vaccination | Number of Participants Who Have Taken Related Sick Leaves | 17 participants |
Secondary
Patient Age According to Vaccination Status
Age (years)
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adherece Vaccination | Patient Age According to Vaccination Status | Age : Influenzae vaccination: | 43.5 years | Standard Deviation 15.2 |
| Adherece Vaccination | Patient Age According to Vaccination Status | Age : No influcenzae vaccination | 39.7 years | Standard Deviation 13 |
| Adherece Vaccination | Patient Age According to Vaccination Status | Age : HBV vaccination | 28.3 years | Standard Deviation 10.8 |
| Adherece Vaccination | Patient Age According to Vaccination Status | Age : HBV pneumoccocal vaccination | 44.5 years | Standard Deviation 13.5 |