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CompletedNCT07471906Updated Mar 13, 2026

Compliance to Vaccination in Children With Diabetes and Their Siblings

An observational study in Type 1 Diabetes, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
1 Month to 18 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Type 1 Diabetes
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In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 60 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
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)

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

Exclusion Criteria:

1. Communication problems

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Children with type 1 Diabetes

    Retrospective analysis of their vaccination program

    Behavioral: Compliance to vaccination schedule

  • Siblings of children with Typw 1 Diabetes

    Retrospective analysis of their vaccination program

    Behavioral: Compliance to vaccination schedule

Interventions

  • BehavioralCompliance to vaccination schedule

    Record the percentage of performed vaccination / required vaccination

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What researchers measure

Primary outcomes

  1. Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart

    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®).

    Time frame: 3-6 months after insulin switch

Secondary outcomes

  1. Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart

    Percentage of time that interstitial glucose levels are above 180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).

    Time frame: 3-6 months after switching insulin

  2. Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart

    Mean HbA1c (%) calculated from laboratory measurements over the 12 months before and after insulin switch

    Time frame: 12 months

  3. Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart

    Percentage of time that interstitial glucose levels are below 70 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).

    Time frame: 3-6 months after switching insulin

  4. Change in total daily insulin dose and basal/bolus proportions

    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.

    Time frame: 3-6 months after switching insulin

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Study locations

1 site
  • Aristotle University of Thessaloniki
    Thessaloniki, 54246, Greece
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07471906
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
Athanasios Christoforidis (Assistant Professor in Pediatric Endocrinology, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Mar 13, 2026
Start date
Nov 1, 2019
Primary completion
Nov 30, 2019
Completion
Dec 15, 2019
Last update
Mar 13, 2026

Study contacts

Athanasios Christoforidis, PhD
principal investigator · Aristotle University Of Thessaloniki

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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