Compliance to Vaccination in Children With Diabetes and Their Siblings

NCT07471906 | Completed

• 1 other identifier: AUTH-AC-2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

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®).

  3-6 months after insulin switch

Secondary Outcomes (4)

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

  3-6 months after switching insulin

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

  12 months

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

  3-6 months after switching insulin

• Change in total daily insulin dose and basal/bolus proportions

  3-6 months after switching insulin

Study Arms (2)

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

Compliance to vaccination schedule BEHAVIORAL

Record the percentage of performed vaccination / required vaccination

Children with type 1 Diabetes; Siblings of children with Typw 1 Diabetes

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

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

You may not qualify if:

• \. Communication problems

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54246, Greece

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Athanasios Christoforidis, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatric Endocrinology

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: March 13, 2026
• Study Start: November 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 15, 2019
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

GR (1)