Understanding factors affecting blood sugar control in children with Type 1 diabetes
Exploring Genetic, Epigenetic and Environmental Determinants of Glycaemic Control in Children and Young Individuals With Type 1 Diabetes
This study looks at how genetics, gut bacteria, and other factors affect blood sugar control in children with Type 1 diabetes to help improve their management and reduce complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 6 Years to 20 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT06325111 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the determinants of glycaemic control in children aged 6 to 20 years with Type 1 diabetes. It will explore the relationship between genetic factors, epigenetic modifications, and the role of the microbiome in managing blood sugar levels. By analyzing clinical histories and biological samples, the study seeks to uncover how these factors contribute to the risk of diabetes-related complications. The findings could enhance understanding of glycaemic control mechanisms in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 6 to 20 years who have been diagnosed with Type 1 diabetes for at least 5 years.
Not a fit: Patients with other types of diabetes or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing blood sugar levels in children with Type 1 diabetes, potentially reducing the risk of complications.
How similar studies have performed: While there is ongoing research into glycaemic control in Type 1 diabetes, this study's specific focus on epigenetic factors and the microbiome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes subjects * Age from 6 to 20 years old * At least 5 years of duration of disease Exclusion Criteria: * Type 1 diabetes subjects incapable of giving valid informed consent or whose parents are incapable of giving valid informed consent. * Type 1 diabetes subjects for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes * Subjects with other types of diabetes (i.e. type 2, monogenic diabetes, cystic fibrosis related diabetes)
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Eulalia Catamo, BSc
- Email: eulalia.catamo@burlo.trieste.it
- Phone: 040.3785470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.