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Clinical and Laboratory Characteristics of a Population of Children and Adolescents With Newly Diagnosed Type 1 Diabetes and Insulin Requirements at Onset
NCT06717893 · IRCCS Azienda Ospedaliero-Universitaria di Bologna
In plain English
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About this study
The primary aim of this observational, retrospective, single-centre, non-pharmacological study is to assess whether the presence of clinical and laboratory predictive factors at the onset of type 1 diabetes may be related to an increased insulin requirement in a population of pediatric and adolescent patients with diagnosis of type 1 diabetes between January 2014 and December 2018 at the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy. The secondary aim is to assess the insulin requirement 1 year after the onset of type 1 diabetes. This study consists of collection and analyses of clinical and laboratory data of patients enrolled.
Eligibility 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.
Study design
Enrollment target: 180 participants
Age groups: child
Timeline
Starts: 2020-10-09
Estimated completion: 2024-12-31
Last updated: 2024-12-05
Primary outcomes
- • Insulin requirement (at onset of type 1 diabetes, 3 months, and 12 months)
- • Laboratory data (at onset of type 1 diabetes, 3 months, and 12 months)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · other
Contacts & investigators
ContactGiulio Maltoni, MD · contact · giulio.maltoni@aosp.bo.it · 00390512144816
InvestigatorGiulio Maltoni, MD · principal_investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
All locations (1)
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
Bologna, Italy