NCT04174508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 24, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

4.8 years

First QC Date

November 5, 2019

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria

    5 years

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

child or adolescent with diabetes

You may qualify if:

  • 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

You may not qualify if:

  • Patient not residing in the usual way in Reunion island

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Groupe Hospitalier Est Réunion

Saint-Benoît, France

RECRUITING

Centre Hospitalier Universitaire Réunion

Saint-Denis, France

RECRUITING

Centre Hospitalier Ouest Réunion

Saint-Paul, France

RECRUITING

Centre Hospitalier Universitaire Réunion

Saint-Pierre, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Laure HOUDON, MD

    Centre Hospitalier Universitaire de La REUNION

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 22, 2019

Study Start

March 24, 2020

Primary Completion

January 1, 2025

Study Completion

July 1, 2025

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations