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NCT Number: NCT07471906

Compliance to Vaccination in Children With Diabetes 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aristotle University of Thessaloniki

Thessaloniki, 54246, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Communication problems

Treatment and study plan

Compliance to vaccination schedule

Behavioral

Record the percentage of performed vaccination / required vaccination

Primary outcomes

  1. 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®).

Secondary outcomes

  1. 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®).

  2. 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

  3. 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®).

  4. 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.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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