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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with type 1 Diabetes | Retrospective analysis of their vaccination program |
| |
| Siblings of children with Typw 1 Diabetes | Retrospective analysis of their vaccination program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compliance to vaccination schedule | Behavioral | Record the percentage of performed vaccination / required vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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®). | 3-6 months after switching insulin |
| Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart |
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Inclusion Criteria:
Exclusion Criteria:
1. Communication problems
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Athanasios Christoforidis, PhD | Aristotle University Of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aristotle University of Thessaloniki | Thessaloniki | 54246 | Greece |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 | 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 | 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |