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DIABIRUN: Non-insulino-dependant Diabetes in Infants and Teenagers

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Recruiting
CT.gov ID
NCT04174508
Collaborator
(none)
150
Enrollment
4
Locations
63.2
Anticipated Duration (Months)
37.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The incidence of diabetes in children, which is constantly increasing worldwide is estimated in mainland France at about 15/100 000 per year with a wide disparity between countries and a north gradient South.

In Reunion island, about 30 children a year seem to reveal diabetes before the age of 18 years but no precise data has ever been published on this subject.

Indeed, while type 1 diabetes (insulin-dependent autoimmune) represents historically the majority of cases of diabetes revealed at pediatric age (about 90%), since a little more than 10 years other types of diabetes seem emerge at pediatric age. This is particularly the case of type 2 diabetes in connection with the global epidemic of obesity.

The purpose of the investigator's study is the exhaustive prospective collection of all cases of diabetes revealed before the age of 18 in the Reunion region over a period of 5 years.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Incidence of Diabetes Revealed at Pediatric Age in Reunion
    Actual Study Start Date :
    Mar 24, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • child or adolescent residing in the territory of the reunion island

    • with a diagnosis that revealed diabetes according to criteria defined by WHO (World Health Organization) before 18 years of age

    • Parents who signed the participation consent

    Exclusion Criteria:
    • Patient not residing in the usual way in Reunion island

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Est Réunion Saint-Benoît France
    2 Centre Hospitalier Universitaire Réunion Saint-Denis France
    3 Centre Hospitalier Ouest Réunion Saint-Paul France
    4 Centre Hospitalier Universitaire Réunion Saint-Pierre France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de la Réunion

    Investigators

    • Principal Investigator: Laure HOUDON, MD, Centre Hospitalier Universitaire de La REUNION

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de la Réunion
    ClinicalTrials.gov Identifier:
    NCT04174508
    Other Study ID Numbers:
    • 2014/CHU/10
    First Posted:
    Nov 22, 2019
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of Nov 24, 2021