DiabetesDIABIRUNNCT04174508
Non-insulino-dependant Diabetes in Infants and Teenagers
An observational study of Diabetes and Pediatric Disorder, run by Centre Hospitalier Universitaire de la Réunion at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diabetes, Pediatric Disorder
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Mar 2020to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: child or adolescent with diabetes
Who may be able to join
- 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
Who cannot join
- Patient not residing in the usual way in Reunion island
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Groupe Hospitalier Est Réunion
Saint-Benoît
Lucie AUZANNEAU
Yogananda THIRAPATHI, PH
- Recruiting
Centre Hospitalier Universitaire Réunion
Saint-Denis
Lucie AUZANNEAU
Patricia PIGEON-KHERCHICHE, PH
- Recruiting
Centre Hospitalier Ouest Réunion
Saint-Paul
Lucie AUZANNEAU
Karine BERNY-BURLOT, PH
- Recruiting
Centre Hospitalier Universitaire Réunion
Saint-Pierre
Lucie
Laure HOUDON, PH
About this study
Official title: Evaluation of the Incidence of Diabetes Revealed at Pediatric Age in Reunion
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.
Read more
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.
- Conditions
- Diabetes, Pediatric Disorder
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Mar 2020
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure HOUDON, MD, Principal investigator, Centre Hospitalier Universitaire de La REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174508
- Sponsor's protocol ID
- 2014/CHU/10
- Acronym
- DIABIRUN
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2019
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Diabetes Revealed at Pediatric Age in Reunion
- ClinicalTrials.gov ID
- NCT04174508
- Acronym / sponsor ID
- DIABIRUN / 2014/CHU/10
- Conditions
- Diabetes, Pediatric Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- child or adolescent with diabetes
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient not residing in the usual way in Reunion island
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure HOUDON, MD principal investigator
Centre Hospitalier Universitaire de La REUNION
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Pediatric Disorder, run by Centre Hospitalier Universitaire de la Réunion at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU ((0)262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.