Compliance to Vaccination in Children With Diabetes and Their Siblings

March 12, 2026 updated by: Athanasios Christoforidis, Aristotle University Of Thessaloniki

Compliance to Obligatory and Recommended Vaccination in Children With Type 1 Diabetes Mellitus and Their Siblings

This is an observational, single-center, cross-sectional study about adherence to both obligatory and recommended vaccination in children with Type 1 Diabetes Mellitus and their siblings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A great amount of discussion has been made regarding the possible association between routine vaccinations and the risk of childhood type 1 diabetes mellitus. This study is designed to explore the level of compliance to obligatory and recommended vaccinations in children after being diagnosed with Type 1 Diabetes Mellitus and their siblings.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54246
        • Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parents or legal-caregivers of children diagnosed with Type 1 Diabetes Mellitus will be asked to provide information regarding the vaccination status of their children (date of performed vaccinations)

Description

Inclusion Criteria:

  1. Willingness to participate in the study
  2. Informed consent obtained by parents or legal caregivers before any trial-related activities.
  3. Documented diagnosis of tyoe 1 Diabetes mellitus in one children of the family
  4. Written documents on vaccination schedules in participating subjects (children with Type 1 Diabetes and siblings)

Exclusion Criteria:

1. Communication problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with type 1 Diabetes
Retrospective analysis of their vaccination program
Behavioral: Compliance to vaccination schedule
Record the percentage of performed vaccination / required vaccination
Siblings of children with Typw 1 Diabetes
Retrospective analysis of their vaccination program
Behavioral: Compliance to vaccination schedule
Record the percentage of performed vaccination / required vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart
Time Frame: 3-6 months after insulin switch
Percentage of time that interstitial glucose levels are between 70-180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
3-6 months after insulin switch

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart
Time Frame: 3-6 months after switching insulin
Percentage of time that interstitial glucose levels are above 180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
3-6 months after switching insulin
Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart
Time Frame: 12 months
Mean HbA1c (%) calculated from laboratory measurements over the 12 months before and after insulin switch
12 months
Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart
Time Frame: 3-6 months after switching insulin
Percentage of time that interstitial glucose levels are below 70 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
3-6 months after switching insulin
Change in total daily insulin dose and basal/bolus proportions
Time Frame: 3-6 months after switching insulin
Total daily insulin (U/kg/day) and percentage of basal and bolus insulin, obtained from clinical records before and after switching to ultra-rapid insulin aspart.
3-6 months after switching insulin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Athanasios Christoforidis, PhD, Aristotle University of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTH-AC-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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