Actively Recruiting

Age: 0 - 14Years
All Genders
ID06717893

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-05

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates children and adolescents newly diagnosed with Type 1 Diabetes, focusing on clinical and laboratory factors that might predict changes in insulin sensitivity and requirements at the disease onset. The goal is to help doctors quickly find the right insulin dosage for better early metabolic control and reduce hospitalization time and costs. The study is observational and retrospective, analyzing medical records from patients diagnosed between 2014 and 2018. The study collects and reviews clinical and laboratory data from pediatric patients diagnosed with Type 1 Diabetes at a single center. It evaluates insulin needs at diagnosis, 3 months, and 12 months after onset, aiming to link these requirements with initial clinical and laboratory factors. No new treatments are given; instead, existing patient data is analyzed to understand insulin needs over time. Participants' medical records are used to track insulin dosage and laboratory results at diagnosis and during follow-up visits up to one year. The study measures insulin requirements and lab data at diagnosis, 3 months, and 12 months to identify predictive factors. There is no active treatment or intervention, and participation involves data collection only, with the study ending after data analysis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years or younger at time of Type 1 Diabetes diagnosis
  • 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
  • At least 1 year of follow-up after diagnosis
  • Informed consent obtained from parents or legal guardians
Not Eligible

You will not qualify if you...

  • Diagnosis of diabetes other than Type 1
  • Patients followed at other centers at the time of Type 1 Diabetes onset

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants who were diagnosed with Type 1 Diabetes are observed with collection and analysis of clinical and laboratory data at onset, 3 months, and 12 months after diagnosis.

3 visits (in-person) at onset, 3 months, and 12 months

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

G

Giulio Maltoni, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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