Type 1 DiabetesAVADI-2NCT05481801
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 1 site in Spain.
Trial summary
Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Covid-19 vaccination, Influenza vaccination and Pneumococal vaccination
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All type 1 diabetes patients attendet at the Ciudad Real General University Hospital.
Who may be able to join
- Type 1 diabetes
- Age: 18 yrs. or older
Who cannot join
- Other diabetes types.
- Younger than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Read the 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
- Being tested
- Covid-19 vaccination, Influenza vaccination, Pneumococal vaccination, Hepatitis B Virus (HBV) vaccination
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 vaccinationBiological
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.
Influenza vaccinationBiological
Correct influenza vaccination status was considered in the following situation:
- Received at least one Influenza vaccine dose in the last year.
Pneumococal vaccinationBiological
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) vaccinationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination adherence | All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Covid-19, Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status. Receives: Biological: Covid-19 vaccination; Biological: Influenza vaccination; Biological: Pneumococal vaccination; Biological: Hepatitis B Virus (HBV) vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination adherence
Adherence 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
Measured: 1 year and a half
Secondary outcomes (3)
Sick Leaves
Total number of related sick leaves due to Covid-19, pneumococcus, influenzae or HBV according to vaccination status (vaccinated or not vaccinated).
Measured: 1 year and a half
Hospital admission
Number of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.
Measured: 1 year and a half
Death
Mortality rate according to vaccination status
Measured: 1 year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481801
- Sponsor's protocol ID
- C-549
- Acronym
- AVADI-2
- Status last verified
- Feb 2023
- First submitted
- 25 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical IPD will be available at request from others researchers.
Publications
Moreno-Fernandez J, Garcia-Seco JA, Rodrigo EMO, Segura AMS, Garcia-Seco F, Munoz-Rodriguez JR. Vaccination adherence to influenza, pneumococcal and hepatitis B virus in adult type 1 diabetes mellitus patients. Prim Care Diabetes. 2020 Aug;14(4):343-348. doi: 10.1016/j.pcd.2019.09.004. Epub 2019 Sep 30.
PubMed 31582202Giatraki V, Dimitriou H, Pappas A, Mamoulakis D, Makris G, Galanakis E, Perdikogianni C. Vaccine coverage in children, adolescents and adults with type 1 diabetes and their close contacts in Crete. Hum Vaccin Immunother. 2021 Nov 2;17(11):4291-4298. doi: 10.1080/21645515.2021.1973882. Epub 2021 Oct 6.
PubMed 34613871Wang CH, Jones J, Hilliard ME, Tully C, Monaghan M, Marks BE, Hildebrandt T, Streisand R. Correlates and Patterns of COVID-19 Vaccination Intentions among Parents of Children with Type 1 Diabetes. J Pediatr Psychol. 2022 Aug 12;47(8):883-891. doi: 10.1093/jpepsy/jsac048.
PubMed 35689648
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
- ClinicalTrials.gov ID
- NCT05481801
- Acronym / sponsor ID
- AVADI-2 / C-549
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination adherence | – | Biological: Covid-19 vaccination, Biological: Influenza vaccination, Biological: Pneumococal vaccination, Biological: Hepatitis B Virus (HBV) vaccinationAll type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Covid-19, Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All type 1 diabetes patients attendet at the Ciudad Real General University Hospital.
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Age: 18 yrs. or older
Key exclusion criteria (2 listed)
- Other diabetes types.
- Younger than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid-19 vaccinationCorrect 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 | Vaccination adherence |
| Influenza vaccinationCorrect influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year. | Biological | Vaccination adherence |
| Pneumococal vaccinationCorrect 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 | Vaccination adherence |
| Hepatitis B Virus (HBV) vaccinationCorrect 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. | Biological | Vaccination adherence |
Primary outcome
Vaccination adherence
Time frame: 1 year and a half
Adherence 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
3 secondary outcomes
Sick Leaves
Time frame: 1 year and a half
Hospital admission
Time frame: 1 year and a half
Death
Time frame: 1 year and a half
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Results publication: PubMed 31582202Moreno-Fernandez J, Garcia-Seco JA, Rodrigo EMO, Segura AMS, Garcia-Seco F, Munoz-Rodriguez JR. Vaccination adherence to influenza, pneumococcal and hepatitis B virus in adult type 1 diabetes mellitus patients. Prim Care Diabetes. 2020 Aug;14(4):343-348. doi: 10.1016/j.pcd.2019.09.004. Epub 2019 Sep 30.
- Results publication: PubMed 34613871Giatraki V, Dimitriou H, Pappas A, Mamoulakis D, Makris G, Galanakis E, Perdikogianni C. Vaccine coverage in children, adolescents and adults with type 1 diabetes and their close contacts in Crete. Hum Vaccin Immunother. 2021 Nov 2;17(11):4291-4298. doi: 10.1080/21645515.2021.1973882. Epub 2021 Oct 6.
- Results publication: PubMed 35689648Wang CH, Jones J, Hilliard ME, Tully C, Monaghan M, Marks BE, Hildebrandt T, Streisand R. Correlates and Patterns of COVID-19 Vaccination Intentions among Parents of Children with Type 1 Diabetes. J Pediatr Psychol. 2022 Aug 12;47(8):883-891. doi: 10.1093/jpepsy/jsac048.
- Individual participant dataSharing planned: No. Clinical IPD will be available at request from others researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination adherence (time frame: 1 year and a half). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481801, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.