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Vaccination Coverage in People Linving With Diabetes (VacDiab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04391088
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

For several years, the prevalence of people living with diabetes (pDT) has been steadily increasing. It was estimated by the health insurance in 2016 at 5 %, or more than 3.3 million people in France. By different physiological mechanisms, diabetes is associated with immunodeficiency. As a result, several vaccines are recommended in pDT.

The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. This vaccine is especially indicated for this segment of the population because diabetes is a risk factor for tetanus. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for pDT according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious for these patients compared to the general population. Influenza vaccine has to be done annually in the early winter period. The vaccine coverage for winter 2018/2019 was estimated at 46.8 % of the target population. The vaccination scheme for pneumococcal vaccine is more complex: it involves a primary vaccination with a vaccine with 13 valences followed by another with 23 valences at least eight weeks later. Thereafter, a recall is to be carried out every five years with the 23 valences vaccine. Vaccination coverage was estimated in France in 2011 at 8.1 % in the population at risk.

According to several studies, the shingles virus has a greater impact and is more aggressive in pDT than in the general population. Similarly, the virus would tend to unbalance diabetes. There is currently a vaccine against shingles that is recommended and reimbursed in the population aged 65 to 74 years.

In our practice, a pharmaceutical team has been carrying out medication reconciliation for several years at the hospital admission and discharge of the patient in the endocrinology-nutrition department of the university hospital of Montpellier.

During this medication reconciliation, a pharmaceutical interview on the management of drug treatments is carried out . Since May 2019, we added to this interview an assessment of the vaccination coverage and feelings of people regarding vaccination. Following this assessment, a report is made during an interview with the doctor responsible for the patient. During this interview, the update of mandatory and recommended vaccinations are discussed between the doctor and the pharmacist.

In this context, it seems interesting to us to make an assessment of our practices and the investigator make the following assumptions:

  • There is a defect in the mandatory and recommended process of vaccination for pDT
  • A synthesis of pDT vaccine status between the physician and the pharmacist at the time of hospitalization would allow optimization of vaccine management in accordance with current recommendations and practices.

The main objective of the study is to assess vaccine coverage for mandatory and recommended pDT vaccines at hospital admission.

The secondary objectives are:

  • Description of pDT experience with vaccination;
  • Description of the management of vaccination within the Department of Endocrinology-Nutrition-Diabetes during and after the patient's hospitalization in terms of (intra-hospital vaccination, hospital prescriptions of a vaccine after hospitalization and number of vaccination recommendations in the hospitalization report).
  • Description of transmission of vaccination status of patients to their treating physician

Condition or disease Intervention/treatment
Diabetes Other: vaccine coverage assessment

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Study Type : Observational
Estimated Enrollment : 235 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vaccination Coverage in People Linving With Diabetes
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : September 1, 2020

Group/Cohort Intervention/treatment
hospitalized people living with diabetes
hospitalized people living with diabetes
Other: vaccine coverage assessment
vaccine coverage assessment

Primary Outcome Measures :
  1. number of diabetic patients up to date with their mandatory and recommended vaccinations [ Time Frame: 1 day (at hospital admission) ]
    number of diabetic patients up to date with their mandatory and recommended vaccinations

Secondary Outcome Measures :
  1. number of patients vaccinated during hospitalization [ Time Frame: 1 day (from the day of admission to the day of discharge) ]
    number of patients vaccinated during hospitalization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population was composed of people living with diabetes hospitalized in Diabetes-Nutrition unit of Montpellier University hospital

Inclusion criteria:

  • Patients aged above 18 years old,
  • People living with diabetes

Exclusion criteria:

• Patients hospitalized for diabetes discovery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04391088

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Contact: Cyril BREUKER, PharmD,Phd 467337121 ext 33

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Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: cyril BREUKER   
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Cyril BREUKER University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT04391088    
Other Study ID Numbers: RECHMPL19_0575
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
People over 18 years old
Clinical pharmacy
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases