Type 1 Diabetes MellitusAVADI-1NCT03478254

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

An observational study of Type 1 Diabetes Mellitus, run by Jesús Moreno Fernández at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Observational study about adherence to guidelines for 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 Mellitus
What is being tested?: Influenza vaccination, Pneumococcal vaccination and Hepatitis B Virus (HBV) vaccination
Type of treatment: Vaccines
How many people: 300 participants
Where: 1 siteSpain
Study dates: 1 Dec 2017to 31 Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Study population: All patients attended to care in consults during this period were eligible for chart review. Patients included in the analysis were required to be ≥18 years of age and be diagnosed of type 1 diabetes mellitus.

Who may be able to join

≥18 years of age.
Diagnosed of Type 1 Diabetes Mellitus.
Be attended in Ciudad Real General University Hospital.

Who cannot join

Less than 18 years old.
Other types of diabetes mellitus.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Obispo Rafael Torija, St.
Ciudad Real, 13005

Other trials in Spain

About this study

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

Observational study about adherence to guidelines for 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 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 Mellitus
Being tested: Influenza vaccination, Pneumococcal 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.

Influenza vaccinationBiological
Correct influenza vaccination status was considered in the following situation:
- Received at least one Influenza vaccine dose in the last year.
Pneumococcal 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 groups in NCT03478254
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 Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status. Receives: Biological: Influenza vaccination; Biological: Pneumococcal vaccination; Biological: Hepatitis B Virus (HBV) vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year

Secondary outcomes (2)

Patient Age According to Vaccination Status
Age (years)
Measured: 1 year
Number of Participants Who Have Taken Related Sick Leaves
Number of patients who have taken related sick leaves.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201731 Dec 2018

First posted27 Mar 2018
Study start1 Dec 2017
Primary completion1 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies 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: Cross-sectional
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03478254
Sponsor's protocol ID: C-127
Acronym: AVADI-1
Status last verified: Dec 2020
First submitted: 20 Mar 2018
Last updated: 11 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: In request.

Publications

Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care. 2003 Feb;26(2):510-3. doi: 10.2337/diacare.26.2.510.
PubMed 12547890
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. doi: 10.1086/431587. Epub 2005 Jun 16.
PubMed 16007521
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.
PubMed 26203204
Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon 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.
PubMed 23039989
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. No abstract available.
PubMed 24442103
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 31582202

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adherence to Guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in Adult Patients With Type 1 Diabetes Mellitus (AVADI-1).
ClinicalTrials.gov ID: NCT03478254
Acronym / sponsor ID: AVADI-1 / C-127
Conditions: Type 1 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Jesús Moreno FernándezUniversity, hospital or other
Collaborators: Castilla-La Mancha Health Service, University of Castilla-La Mancha
Study start: 1 Dec 2017 (actual)
Primary completion: 1 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 27 Mar 2018 (actual)
Results: Posted 11 Jan 2021

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 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).

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: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Vaccination adherence	–	Biological: Influenza vaccination, Biological: Pneumococcal vaccination, Biological: Hepatitis B Virus (HBV) vaccinationAll type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients attended to care in consults during this period were eligible for chart review. Patients included in the analysis were required to be ≥18 years of age and be diagnosed of type 1 diabetes mellitus.

Key inclusion criteria (3 listed)

≥18 years of age.
Diagnosed of Type 1 Diabetes Mellitus.
Be attended in Ciudad Real General University Hospital.

Key exclusion criteria (2 listed)

Less than 18 years old.
Other types of diabetes mellitus.

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
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
Pneumococcal 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

Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM
Time frame: 1 year
Adherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

2 secondary outcomes

Patient Age According to Vaccination Status
Time frame: 1 year
Number of Participants Who Have Taken Related Sick Leaves
Time frame: 1 year

Results and safety

Results posted to the registry on 11 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influenza Vaccination	300	300

Primary outcome: Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Adherece Vaccination n = 300
influenza vaccination	165
Pneumoccocal vaccination	54
HBV vaccination	51
No vaccination	30

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were not collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adherence Vaccination	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12547890Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care. 2003 Feb;26(2):510-3. doi: 10.2337/diacare.26.2.510.
Background: PubMed 16007521Muller 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. doi: 10.1086/431587. Epub 2005 Jun 16.
Background: PubMed 26203204Alcusky 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.
Background: PubMed 23039989Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon 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.
Background: PubMed 24442103American 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. No abstract available.
Derived from this study: 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.
Individual participant dataSharing planned: Yes. In request.

Related trials for Type 1 Diabetes Mellitus

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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.

Elena M Ortega Rodrigo study chair

University of Castilla-La Mancha

Jose Alberto Garcia Seco, RN study chair

University of Castilla-La Mancha

Fernando Garcia Seco study chair

Universidad de Córdoba

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 Mellitus, run by Jesús Moreno Fernández 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 3 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 11 Jan 2021. 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?

Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM (time frame: 1 year). 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 NCT03478254, which also lists 6 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 11 Jan 2021.