Understanding insulin needs in children with newly diagnosed Type 1 Diabetes
Clinical and Laboratory Characteristics of a Population of Children and Adolescents With Newly Diagnosed Type 1 Diabetes and Insulin Requirements at Onset
This study looks at how different factors can help us understand insulin needs in children and teens who have just been diagnosed with Type 1 Diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06717893 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify clinical and laboratory factors that may predict insulin sensitivity in children and adolescents diagnosed with Type 1 Diabetes. By analyzing data from patients diagnosed between January 2014 and December 2018 at a single center in Bologna, Italy, the study seeks to determine how these factors relate to insulin requirements at the onset of the disease. The goal is to enable quicker and more effective therapeutic interventions, potentially reducing hospitalization time and costs. Additionally, the study will assess insulin requirements one year after diagnosis.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 14 years or younger who were diagnosed with Type 1 Diabetes between January 2014 and December 2018.
Not a fit: Patients with diabetes types other than Type 1 or those who were diagnosed and treated at other centers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective insulin therapies for children with Type 1 Diabetes, improving their metabolic control.
How similar studies have performed: While similar studies have explored insulin requirements in Type 1 Diabetes, this specific approach focusing on early predictive factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≤ 14 years at the time of diagnosis of type 1 diabetes; * Diagnosis of type 1 diabetes confirmed between January 2014 and December 2018 at the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy; * Patients with at least 1 year of follow-up after diagnosis od type 1 diabetes; * Obtaining informed consent from parents/legal guardian of pediatric patients. Exclusion Criteria: * Patients with diabetes other that type 1; * Patients followed at other centres at the time of onset of type 1 diabetes.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Giulio Maltoni, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Giulio Maltoni, MD
- Email: giulio.maltoni@aosp.bo.it
- Phone: 00390512144816
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.