National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes

Diabetes Type 1 Clinical Trial

— EPISTRESS2  

Official title:

National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06365255
• Other study ID #: 2022-A01453-40
• Status: Completed
• Start date: January 17, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1344
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Type 1

Intervention

Other:
• questionnaires
filling in questionnaires

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Avignon Hospital	Avignon
France	St André Hospital	Bordeaux
France	Brest University Hospital	Brest
France	Dijon University Hospital	Dijon
France	CERITD	Evry
France	Grenoble University Hospital	Grenoble
France	Lille University Hospital	Lille
France	APHM- La Conception Hospital	Marseille
France	Private practice in endocrinology and metabolic diseases	Mérignac
France	Srasbourg University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.	Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels. This questionnaire was designed and developed by CERITD to assess the impact of perceived stress on blood glucose levels in T1DM patients.	30 minutes
Secondary	Identify sub-populations of patients who feel stressed	Identify and profile a sub-population of patients whose blood glucose levels rise in response to stress; Identify and profile a sub-population of patients whose blood glucose levels decrease in response to stress; Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels	30 minutes
Secondary	Establish and categorise the different stress factors	Cungi brief stress evaluation scales The Cungi 1 scale is composed of 8 items. This questionnaire assesses patient stressors.; The maximum score is 48, the minimum score is 8. A high score reflects a large number of stressors; The Cungi 2 scale is composed of 11 items. This questionnaire assesses the patient's sensitivity to stress.; The maximum score is 66, the minimum score is 11. A high score reflects a high senstivity of stress.	30 minutes
Secondary	Establishing a relationship between personality type and the impact of stress	State-Trait Anxiety Inventory (STAI) questionnaire. The STAI-Y1 is composed of 20 items. This questionnaire assesses how the patient feels at the present moment. Patients are asked to score each question on a four-point scale (from 1 - corresponding to "not at all" to 4 - "much"); The STAI-Y2 is composed of 20 items. This questionnaire assesses how the patient feels in general.; Patients are asked to answer each question on a four-point scale (from 1 - corresponding to "almost never" to 4 - "almost always").	30 minutes
Secondary	Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities	EQ-5D-5L (European Quality of Life 5 Dimensions) questionnaire The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on five levels of severity. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform (5)	30 minutes