Clinical and Laboratory Characteristics of a Population of Children and Adolescents With Newly Diagnosed Type 1 Diabetes and Insulin Requirements at Onset

NCT06717893 | Recruiting

• 1 other identifier: ESORD1T
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical implication of this study lies in the identification of factors that may predict reduced insulin sensitivity in children and adolescents at the onset of Type 1 Diabetes and would help the physician to undertake appropriate therapy more quickly by achieving the correct therapeutic dosage, in order to achieve good metabolic compensation at an early stage and thus reduce the time (and costs) of hospitalisation.

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Insulin requirement

  maximum amount of insulin administered subcutaneously during hospitalisation per kg of body weight in 24 hours (U/kg/die)

  at onset of type 1 diabetes, 3 months, and 12 months

• Laboratory data

  glucose; total cholesterol; HDL cholesterol; triglycerides (mg/dL)

  at onset of type 1 diabetes, 3 months, and 12 months

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adolescent patients with type 1 diabetes onset between January 2014 and December 2018, with age ≤ 14 years at the time of diagnosis, and who referred to the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy.

You may qualify if:

• 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.

You may not qualify if:

• Patients with diabetes other that type 1;
• Patients followed at other centres at the time of onset of type 1 diabetes.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Giulio Maltoni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio Maltoni, MD

CONTACT

00390512144816; giulio.maltoni@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: October 9, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-10

Locations

IT (1)