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

December 1, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Principal Investigator:
          • Giulio Maltoni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin requirement
Time Frame: at onset of type 1 diabetes, 3 months, and 12 months
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
Time Frame: at onset of type 1 diabetes, 3 months, and 12 months
glucose; total cholesterol; HDL cholesterol; triglycerides (mg/dL)
at onset of type 1 diabetes, 3 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Giulio Maltoni, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESORD1T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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