Type 1 Diabetes
Conditions
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.
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.
Interventions
BEHAVIORALCompliance to vaccination schedule
Record the percentage of performed vaccination / required vaccination
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart | 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®). |
| Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart | 12 months | Mean HbA1c (%) calculated from laboratory measurements over the 12 months before and after insulin switch |
| Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart | 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®). |
| Change in total daily insulin dose and basal/bolus proportions | 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. |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORAthanasios Christoforidis, PhD
Aristotle University Of Thessaloniki
Outcome results
None listed