Clinical trial NCT06365255: National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes
Official title: National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Type 1
Keywords: Stress
Glycemic control
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 1344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To study the impact of stress on glycaemia, we chose to conduct an epidemiological study in France on a population of type 1 diabetic patients (T1DM).

Many patients frequently and systematically cite stress as a frequent cause, or even the main cause, of the deterioration in their glycaemic control.

Brief summary: The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.

In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes;
* Do not have a psychiatric pathology;
* At least 18 years old;
* Affiliated to the Social Security;
* Having read the non-opposition form and not objecting to it.

Exclusion Criteria:

* Patient who has declared his opposition using the electronic non-opposition form
* Patient with type 2 diabetes

Primary outcomes:
measure: The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.
timeFrame: 30 minutes
Secondary outcomes:
measure: Identify sub-populations of patients who feel stressed
timeFrame: 30 minutes
measure: Establish and categorise the different stress factors
timeFrame: 30 minutes
measure: Establishing a relationship between personality type and the impact of stress
timeFrame: 30 minutes
measure: Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Avignon
country: France
facility: Avignon Hospital
city: Bordeaux
country: France
facility: St André Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Evry
country: France
facility: CERITD
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Marseille
country: France
facility: APHM- La Conception Hospital
city: Mérignac
country: France
facility: Private practice in endocrinology and metabolic diseases
city: Strasbourg
country: France
facility: Srasbourg University Hospital
Study officials:
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Sylvia Franc, MD
role: PRINCIPAL_INVESTIGATOR
References: