Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT04530292
Eligibility Criteria:
For the prospective group (strategy under study):
* 1 to 16 years old
* Diagnosis of type 1 diabetes (T1D)
* EPICES score \> 30 (if separated parents, highest score)
* Hospitalized at the discovery of T1D in the pediatric diabetology unit of Bordeaux University Hospital
* Parents affiliated to social security
* Living in Gironde
* Consent of the parents or the holders of parental authority for the participation of their child
* Assent of the child
For the retrospective group (classic strategy):
* 1 to 16 years old at diabetes diagnosis
* Diagnosis of type 1 diabetes (T1D) from 1 January 2017 until the start of the study inclusion period
* EPICES score \> 30 (if separated parents, highest score)
* Hospitalized to the discovery of T1D and followed by the pediatric diabetology unit of Bordeaux University Hospital
* Parents affiliated to social security
* Living in Gironde
* For patients who are minor at the time of the study: whose parents or holders of the parental authority have received an individual information and are not opposed to the use of their data (EPICES score and their child's clinical data).
For minors who became adults at the time of the study: having received individual information and are not opposed to the use of the data necessary for the study (EPICES score and their clinical data).
Exclusion criteria:
For the prospective group (strategy under study):
* Absence of the therapeutic education nurse during the child's hospitalization
* Child and/or family who do not speak French
* Family benefiting from the PASS
* Intention of leaving the Gironde department in the first six months of the study
* T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease
For the retrospective group (classic strategy):
* Child and/or family who do not speak French
* Family benefiting from the PASS
* T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT04530292
Study Brief:
Protocol Section:
NCT04530292